Delving into the Latest Updates on Zolbetuximab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Claudiximab, Zolbetuximab-CLZB, 佐贝妥昔单抗

+ [9]

Target

CLDN18.2

Action

inhibitors

Mechanism

CLDN18.2 inhibitors(Claudin 18.2 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Complement dependent cytotoxicity (CDC) effects

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease

Active Indication

Advanced Gastroesophageal Junction AdenocarcinomaCLDN18.2 positive Gastroesophageal junction adenocarcinomaCLDN18.2 positive stomach adenocarcinoma+ [9]

Inactive Indication

AdenocarcinomaCLDN18.2 Positive Gastrointestinal NeoplasmsEsophageal Carcinoma+ [1]

Originator Organization

Ganymed Pharmaceuticals AG

Active Organization

Astellas Pharma Global Development, Inc.

Astellas Pharma China, Inc.Astellas Pharma Europe BV

+ [5]

Inactive Organization

Ganymed Pharmaceuticals AG

License Organization

Shanghai Pharmaceutical Co., Ltd.

Ganymed Pharmaceuticals AG

Astellas Pharma, Inc.

Drug Highest PhaseApproved

First Approval Date

Japan (26 Mar 2024),

CLDN18.2 positive Stomach Cancer

RegulationPriority Review (United States), Accelerated Approval (United States), Orphan Drug (South Korea), Orphan Drug (Australia)

Login to view timeline

Structure/Sequence

Sequence Code 431594752L

Source: *****

Sequence Code 524309292H

Source: *****

Pancreatic cancer is difficult to diagnose early. By the time people have been diagnosed, the cancer has usually spread to other parts of the body (metastatic). The standard treatment is chemotherapy, but other treatments are needed to improve outcomes in people with pancreatic cancer.
In this study, zolbetuximab will be given together with chemotherapy to people with pancreatic cancer. Zolbetuximab attaches to a protein called CLDN18.2 found at high levels on the surface of the cancer tumor. This switches on the immune system to attack the tumor.
Adults 18 years or older with metastatic pancreatic cancer who have not previously had chemotherapy can take part in the study.
There are 2 main aims of this study:
* To check the safety of zolbetuximab, when given with chemotherapy in people with metastatic pancreatic cancer
* To check if people could cope with (tolerate) any medical problems during the study This is an open-label study. This means people in the study and the study doctors will know that people will receive zolbetuximab with chemotherapy. Different small groups will receive lower to higher doses of zolbetuximab with chemotherapy.
Zolbetuximab and chemotherapy will be given through a vein. This is called an infusion. People will receive zolbetuximab on the first day they receive chemotherapy. This will happen every 14 days in a 28-day cycle.
People will receive zolbetuximab and chemotherapy in the study clinic and at home. Also, doctors will check for any medical problems. People will also have a health check including blood tests. On some visits they will also have scans to check for any changes in their cancer.
People will visit the study clinic about 7 days after they stop treatment. They will be asked about any medical problems and will have a health check including blood tests.
After this, people will have several more visits to the study clinic for health checks. The number of visits and checks done at each visit will depend on the health of each person and whether they complete their treatment or not.

Start Date24 Sep 2025

Sponsor / Collaborator

Astellas Pharma Global Development, Inc.

NCT06901531

/ RecruitingPhase 3

A Phase 3, Double-blind, Randomized Study of Zolbetuximab in Combination With Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in Participants Whose Tumors Are HER2-negative, Claudin (CLDN) 18.2-positive and Programmed Death-ligand 1 (PD-L1)-Positive

Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (GEJ) cancer. Zolbetuximab with chemotherapy may be used to treat stomach and GEJ cancer when the cancer cells do not have a protein called HER2 (human epidermal growth factor receptor 2) on their surface (HER2-negative) but do have a protein called Claudin 18.2 (Claudin 18.2-positive). Zolbetuximab is thought to work by attaching to the Claudin 18.2 protein in their tumor, which switches on the body's immune system to attack the tumor. Certain stomach and GEJ cancers may be treated with immunotherapy, which helps the body's immune system fight cancer. This study will give more information about how well zolbetuximab works when given with an immunotherapy medicine called pembrolizumab and chemotherapy. In this study, adults with stomach cancer or GEJ cancer will either be given zolbetuximab with pembrolizumab and chemotherapy or a placebo with pembrolizumab and chemotherapy. A placebo looks like zolbetuximab but doesn't have any medicine in it.
The main aim of the study is to check how long people with stomach cancer and GEJ cancer live after treatment with zolbetuximab with pembrolizumab and chemotherapy compared to placebo with pembrolizumab and chemotherapy.
Adults with locally advanced unresectable or metastatic stomach cancer or GEJ cancer can take part. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. A tumor sample (biopsy) of their cancer will have the Claudin 18.2 protein, PD-L1 protein, and be HER2-negative. They may have been previously treated with certain standard therapies. People cannot take part if they need to take medicines to suppress their immune system, have blockages or bleeding in their gut, have specific uncontrollable cancers such as symptomatic or untreated cancers in the nervous system, or have a specific heart condition, or infections.
The study treatments are either zolbetuximab with pembrolizumab and chemotherapy, or placebo with pembrolizumab and chemotherapy. People who take part will receive just 1 of the study treatments by chance. The people in the study and the study doctors will not know who takes which of the study treatments. Study treatment will be given in 6-week (42-day) cycles. The study treatment is mainly given to people slowly through a tube into a vein. This is called an infusion. People will receive study treatment as follows: Zolbetuximab or placebo: 1 infusion every 2 or 3 weeks (2 or 3 infusions in a cycle) together with: Chemotherapy (1 of the following types of chemotherapy): 1. CAPOX (capecitabine and oxaliplatin): 1 infusion of oxaliplatin every 3 weeks (2 infusions in a cycle). People will also take 1 tablet of capecitabine twice a day for 2 weeks (14 days) at the start of each cycle (Day 1) and again in the middle of each cycle (Day 22). After 8 study treatments people will receive capecitabine only. 2. Modified FOLFOX6 or mFOLFOX6 (5-fluorouracil, folinic acid and oxaliplatin): 1 infusion every 2 weeks (3 infusions in a cycle). After 12 study treatments people will receive folinic acid and fluorouracil only, instead of mFOLFOX6. Pembrolizumab: 1 infusion every 3 or 6 weeks (1 or 2 infusions in a cycle). People can be in the study and will receive study treatment until their cancer worsens, they cannot tolerate the study treatment, or they need to start another cancer treatment. People may receive pembrolizumab for up to 2 years. People will visit the clinic on certain days to receive their study treatment and have health checks. The study doctors will check if people had any medical problems from taking zolbetuximab or the other study treatments. On some visits they will have scans to check for any changes in their cancer. People will have the option of giving a tumor sample if they stop treatment because their cancer has worsened. People will visit the clinic after they stop their study treatment. People will be asked about any medical problems and will have a health check. People will continue to have scans every 9 or 12 weeks to check for any changes in their cancer. They will have telephone health checks every 3 months. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their study treatment or not.

Start Date22 May 2025

Sponsor / Collaborator

Astellas Pharma Global Development, Inc.

100 Clinical Results associated with Zolbetuximab

Login to view more data

100 Translational Medicine associated with Zolbetuximab

Login to view more data

100 Patents (Medical) associated with Zolbetuximab

Login to view more data

160

Literatures (Medical) associated with Zolbetuximab

01 Apr 2026·DEN open

Endoscopic Complete Response to Zolbetuximab for Advanced Gastric Cancer With Claudin 18.2 Positive: A Case Report

Article

Author: Yoshioka, Tsubasa ; Kimura, Rika ; Yamaba, Tomohiro ; Uchiyama, Gaku ; Sasaki, Akinori ; Tachibana, Ayu ; Okamoto, Risa

ABSTRACT:

Recently, zolbetuximab combined with chemotherapy has been approved as a first‐line treatment for advanced gastric cancer (GC). However, to date, no endoscopic images demonstrating endoscopic complete response (eCR) to zolbetuximab plus chemotherapy have been reported. Herein, we report the case of an 80‐year‐old man who presented with epigastric pain and loss of appetite and was diagnosed with undifferentiated GC and peritoneal metastasis. The patient received modified FOLFOX6 plus zolbetuximab because genetic testing revealed HER2‐negative and claudin 18.2‐positive. He experienced grade 2 nausea, which improved with the administration of antiemetic agents. Computed tomography performed at month 5 showed resolution of peritoneal dissemination. Endoscopic examination during the same period showed the disappearance of the primary gastric tumor with scarring. Biopsy of the scar area revealed only inflammatory cells; therefore, the primary lesion was defined as an eCR. To the best of our knowledge, this is the first report of eCR to zolbetuximab and chemotherapy in a patient with GC and claudin 18.2 positive. This case report suggested that chemotherapy combined with zolbetuximab may offer greater therapeutic benefit than chemotherapy combined with immune checkpoint inhibitors in patients with undifferentiated GC. Further analysis is expected to enable the identification of patients with claudin 18.2‐positive GC in whom zolbetuximab treatment is effective.

01 Mar 2026·Cancer diagnosis & prognosis

Expression of CLDN18.2 in Invasive Mucinous Adenocarcinomas of the Lung

Article

Author: Kondo, Tetsuo ; Tahara, Ippei ; Mochizuki, Kunio ; Inoue, Tomohiro ; Kasai, Kazunari

Background/Aim: Invasive mucinous adenocarcinoma (IMA) of the lung is a rare adenocarcinoma subtype with abundant intracytoplasmic mucin and poor response to standard non-small cell lung cancer chemotherapy. Molecularly targeted therapies may be useful in IMA. Zolbetuximab is a chimeric IgG1 monoclonal antibody against Claudin-18.2 (CLDN18.2) that induces cell death in CLDN18.2-positive gastric and gastro-esophageal junction adenocarcinomas. If lung IMAs also highly express CLDN18.2, they may be candidates for zolbetuximab treatment. This study evaluated CLDN18.2 expression in lung IMAs by immunohistochemistry. Materials and Methods: We analyzed surgically resected samples comprising 30 IMAs, 10 non-mucinous adenocarcinomas (NMAs), 10 squamous cell carcinomas (SqCCs), 10 small cell carcinomas (SmCCs), 9 large cell carcinomas (LCCs), and 10 large cell neuroendocrine carcinomas (LCNECs) of the lung. Results: We confirmed CLDN18.2 expression (H-score ≥50 points) in 77% of IMA samples. Its expression was rarely observed in other histological types of lung cancer. Conclusion: CLDN18.2 is frequently expressed in IMAs but rarely in other major lung cancer subtypes, suggesting that zolbetuximab may represent a promising targeted therapy for IMA.

25 Feb 2026·Zhonghua wei chang wai ke za zhi = Chinese journal of gastrointestinal surgery

[Progress of treatment of new targets in gastric cancer].

Review

Author: Xiao, X Y ; Zhuo, M ; Han, T ; Lin, X L

In recent years, biomarkers such as HER-2, PD-L1, and Claudin 18.2 (CLDN 18.2) have provided new opportunities for precision treatment. HER-2-targeted therapies have achieved substantial advancements, while immune checkpoint inhibitors have demonstrated survival benefits in a subset of, but not all patients. CLDN18.2, as an emerging target, has been proven in multiple studies to have potential in the treatment of advanced gastric cancer, with drugs targeting CLDN18.2, such as Zolbetuximab, already approved, opening new pathways for precision treatment. Furthermore, research on targets such as FGFR2b, MET, DKK1, and TROP2 continues, aiming to offer personalized treatment plans for patients with different biomarker profiles. Although the current biomarkers have certain limitations in treatment, the continuous discovery of new targets and the deepening of clinical research hold great promise for precision treatment of gastric cancer and are expected to significantly improve the prognosis of advanced gastric cancer patients.

124

News (Medical) associated with Zolbetuximab

27 Mar 2026

·allsci.com

Astellas terminates first-in-human study of STING inhibitor in Sjögren’s syndrome

Astellas Pharma (Japan) has terminated its Phase I clinical trial of ASP5502, an oral small-molecule STING (Stimulator of Interferon Genes) inhibitor, in healthy adults and patients with primary Sjögren’s syndrome. The clinical trial terminated before completion, according to an updated record on ClinicalTrials.gov (NCT06544642), with the status verified as of March 2026. The study, which began enrolling participants in August 2024 at a Fortrea Clinical Research Unit in Daytona Beach, Florida, had been designed as a first-in-human evaluation of the compound. No results have been posted to the registry. The study was a randomized, double-masked, placebo-controlled Phase I trial with a three-part design: single ascending doses (including a food-effect cohort), multiple ascending doses in healthy volunteers over 14 days, and a 28-day repeated-dose cohort in adults with primary Sjögren’s syndrome without a placebo comparator. The trial planned to enroll 116 participants aged 18–65, with primary endpoints focused on safety and tolerability (adverse events, laboratory abnormalities, vital signs, and ECGs) and secondary endpoints assessing pharmacokinetics and cardiac safety. The Sjögren’s cohort required a diagnosis based on 2016 ACR-EULAR criteria and excluded patients receiving immunosuppressive or B-cell–targeting therapies or with other systemic autoimmune conditions. Termination context The study was terminated for strategic reasons, according to the ClinicalTrials.gov NCT06544642 entry, with no indication of safety concerns or lack of efficacy. The decision comes amid Astellas’ broader efforts to prioritize late-stage and core therapeutic areas, although the company has not publicly linked those changes to ASP5502 specifically. ASP5502 was positioned within Astellas’s immune homeostasis research area, which sits outside the company’s four declared primary focus areas: immuno-oncology, targeted protein degradation, genetic regulation, and blindness and regeneration. Astellas has been executing a systematic drug development pipeline update over the past two years, driven in large part by the approaching patent cliff for enzalutamide (Xtandi), its largest revenue-generating product, with generic competition expected around 2027. The company has concentrated resources on late-stage oncology assets — enfortumab vedotin (Padcev), zolbetuximab (Vyloy), and several degrader and antibody-drug conjugate programs — while pruning early-stage assets in non-core therapeutic areas. Prior discontinuations include a CAR-T program derived from the Xyphos acquisition and a KRAS G12D pancreatic cancer program (ASP4396), with the company recording approximately JPY 12.8 billion in discontinuation-related losses. A February 2025 management restructuring created a new Chief R&D Officer role consolidating oversight of research and development divisions, a move interpreted as tightening portfolio governance. AllSci lists no other active clinical trials for ASP5502, although Astellas has not confirmed the molecule’s discontinuation publicly. The Sjögren’s syndrome landscape Primary Sjögren’s syndrome affects an estimated 0.5% to 1.0% of the adult population, predominantly women, and is characterized by lymphocytic infiltration of exocrine glands leading to sicca symptoms — dry eyes and dry mouth — along with systemic manifestations including fatigue, arthralgia, and organ involvement. Despite its prevalence and burden, no therapy has received FDA approval specifically for the treatment of primary Sjögren’s syndrome. Current management relies on symptomatic relief and off-label use of immunosuppressants. The therapeutic landscape has seen repeated clinical failures. Bristol Myers Squibb’s abatacept did not meet its primary endpoint in a Phase III trial. Novartis tested ianalumab (an anti-BAFF receptor antibody) and reported mixed results, though development continues. GSK’s belimumab, approved for lupus, has been explored in Sjögren’s syndrome without regulatory success in that indication. Horizon Therapeutics (now Amgen) evaluated teprotumumab but in a different autoimmune context. The BAFF/APRIL axis, B-cell depletion, and T-cell co-stimulation blockade have all been pursued with limited translational success in this disease. STING inhibition represented a mechanistically distinct approach. The STING pathway, part of the innate immune system’s cytosolic DNA sensing machinery, has been implicated in the pathogenesis of several autoimmune conditions, including Sjögren’s syndrome, where aberrant type I interferon signaling is a recognized feature. Preclinical rationale for targeting STING in Sjögren’s syndrome rests on the observation that chronic activation of the interferon pathway contributes to glandular inflammation and tissue damage. However, translating STING pathway modulation into clinical benefit in autoimmune disease remains unproven, and ASP5502 was among the first oral STING inhibitors to enter human testing for this indication. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Phase 1Phase 3ImmunotherapyClinical Result

10 Mar 2026

·endpoints.news

BioNTech co-founders to exit company and start a new one

Uğur Şahin and Özlem Türeci are set to leave BioNTech by the end of the year and establish a new company dedicated to next-generation mRNA innovations. BioNTech itself will narrow its focus to its late-stage pipeline, and the hunt is on to find a new leadership team. BioNTech said Tuesday that it would contribute certain rights and mRNA technologies to the new, as-yet-unnamed company “on an arm’s length basis” in exchange for a minority stake and possible milestones and royalties. A binding agreement is set to be signed by the end of June. Exactly what this new biotech will work on is not wholly clear, with the announcement simply saying “next-generation mRNA innovations with disruptive potential.” “Özlem and I are ready to become pioneers once again,” Şahin said in a statement. “Our vision has always been to translate our science into meaningful advances for patients, and we see extraordinary opportunities to unlock the next generation of transformative innovations.” Aside from the part-ownership by BioNTech, the new entity will have distinct resources, operations and funding options. The idea is that the two companies’ different strategic priorities — one focused on discovery and early development of new tech, the other on late-stage development and commercialization — will create more value for shareholders. Helmut Jeggle, chairman of BioNTech’s supervisory board, said the two companies might work together on potential combination therapies. Şahin, BioNTech’s CEO, and Türeci, the company’s chief medical officer, founded the company in 2008 with Christoph Huber, initially focusing on cancer. It hit the big time when the biotech used its mRNA expertise to develop a highly effective — and highly lucrative — shot for Covid-19, in collaboration with Pfizer. In recent years, BioNTech has worked hard to diversify away from the Covid vaccine, which remains its only marketed product. Its revenue from the vaccine fell from a peak of nearly €19 billion (about $21 billion) in 2021 to €2.8 billion in 2024, as the pandemic eased. BioNTech’s 2025 revenue came in at €2.9 billion, BioNTech said in a separate release Tuesday. The company’s net loss was €1.1 billion, up from €665 million the year prior. Its sales guidance for 2026 is between €2 billion and €2.3 billion. BioNTech’s late-stage pipeline is cancer-focused. It includes gotistobart, an anti-CTLA-4 antibody for lung cancer; pumitamig, a bispecific in the hot space of targeting PD-L1 and VEGF-A, in Phase 3 development for lung and breast cancers; and the HER2-targeting antibody-drug conjugate trastuzumab pamirtecan, for breast and endometrial cancer. The latter could become BioNTech’s next approved product, though not in the US. Following a successful China-based trial conducted by BioNTech’s partner DualityBio, a Chinese BLA filing is being planned. BioNTech said that its pipeline will be unaffected by the plans for the new company, adding that it expects to have 15 ongoing Phase 3 cancer trials by the end of 2026, eight of which will be for pumitamig, in collaboration with Bristol Myers Squibb. BioNTech also has six late-stage data readouts that “will inform regulatory and launch plans” across various cancers on this year’s slate. Soon after that, Şahin and Türeci will be at their new company, their third startup. In 2001, they founded Ganymed Pharmaceuticals, and 15 years later, sold it to Astellas for $1.4 billion. The centerpiece of that deal was a Claudin18.2-targeted antibody, which was approved in the US as Vyloy last year. The Tuesday announcement adds to a long string of departures so far this year that includes CEOs from Bavarian Nordic , Sarepta , Sanofi , Alkermes , CSL and Charles River . Editor’s note: This article was updated to include BioNTech’s 2025 financial results.

VaccineAcquisitionmRNAFinancial StatementPhase 3

24 Feb 2026

·www.biospace.com

Astellas Bets up to $1.7B for Vir’s ‘Robust Competitor’ in Prostate Cancer

iStock, master1305 In a Phase 1 study, 82% of patients on VIR-5500 achieved at least a 50% reduction in PSA levels—a result analysts praised as competitive in the prostate cancer space. Astellas Pharma is committing $335 million and betting over a billion more to collaborate with Vir Biotechnology on a T cell engager that analysts at Truist Securities called a “robust competitor” in the prostate cancer market. Under the terms of the agreement, Astellas will make a $240 million cash payment, a $75 million equity investment and pay a $20 million near-term award. Vir will also be eligible for up to $1.37 billion in development, regulatory and sales milestones, plus double-digit royalties on sales outside the U.S., according to a Monday release . The deal’s centerpiece is VIR-5500, an investigational T cell engager that uses a bispecific molecule to bind to both the prostate-specific membrane antigen (PSMA) and CD3 proteins. Through this mechanism of action, the drug stimulates the immune system and directs its response to the target malignant cells. VIR-5500 was developed using Vir’s PRO-XTEN masking technology , which renders therapies inactive until they are in the vicinity of a tumor. Phase 1 data, also released Monday , showed that VIR-5500 elicited a dose-dependent anti-tumor response, with 82% of treated patients achieving a 50% or greater decrease in prostate-specific antigen (PSA) levels, a biomarker of the cancer. Meanwhile, 53% saw at least a 90% PSA reduction. Reacting to the early-stage readout, Truist said VIR-5500 “emerges as a more robust contender” among PSMA-targeting therapies. Vir’s masking technology, they continued, “enables high-dose VIR-5500 administration,” leading to stronger treatment responses than other treatments under development. Under the terms of the agreement, Astellas will be responsible for 60% of VIR-5500’s global development costs, while Vir will shoulder the remaining 40%. Vir will continue to conduct the asset’s Phase 1 development, after which Astellas will take over all subsequent development activities. Vir will have the option to co-promote VIR-5500 in the U.S., with profits and losses split evenly. Astellas will have exclusive rights abroad. The deal for VIR-5500 beefs up Astellas’ prostate cancer portfolio, which currently is anchored by the oral drug Xtandi . In the first nine months of the company’s 2025 fiscal year, Xtandi made $4.72 billion . The biotech is also advancing abiraterone decanoate, a small-molecule drug in Phase 2 development. Astellas’ other cancer products include the Pfizer-partnered bladder cancer drug Padcev and the stomach cancer therapy Vyloy. For Vir, the Astellas agreement gives it access not just to additional capital but also to a proven market infrastructure. “Astellas’ established commercial footprint in prostate cancer through Xtandi further strengthens the strategic positioning of VIR-5500,” Truist said.

Phase 1License out/inPhase 2Clinical ResultPROTACs

100 Deals associated with Zolbetuximab

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
-	Zolbetuximab	-	DB15118

R&D Status

Approved

10 top approved records.

Login

to view more data

Indication	Country/Location	Organization	Date
Advanced Gastroesophageal Junction Adenocarcinoma	Canada	Astellas Pharma Canada, Inc.	09 Jan 2025
CLDN18.2 positive Gastroesophageal junction adenocarcinoma	United Kingdom	Astellas Pharma, Inc.	14 Aug 2024
CLDN18.2 positive stomach adenocarcinoma	United Kingdom	Astellas Pharma, Inc.	14 Aug 2024
CLDN18.2 positive Stomach Cancer	Japan	Astellas Pharma, Inc.	26 Mar 2024

Developing

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	United States	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	China	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Japan	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Argentina	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Canada	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Croatia	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Greece	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Ireland	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Malaysia	Astellas Pharma Global Development, Inc.	28 Nov 2018
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	Netherlands	Astellas Pharma Global Development, Inc.	28 Nov 2018

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06901531 (LUCERNA, ASCO_GI2026)	Phase 3	Locally Advanced Gastroesophageal Junction Adenocarcinoma \| PD-L1 positive Solid Tumors \| CLDN18.2 positive stomach adenocarcinoma First line CLDN18.2-positive \| HER2-negative \| PD-L1-positive	500	Zolbetuximab + pembrolizumab + CAPOX/mFOLFOX6	ontpjlrmik(xortnaqpgt) = gqljiarijl rgwdfnmlfj (odxwfgbnsw, 24.9 - NR)	Positive	08 Jan 2026
				Placebo + pembrolizumab + CAPOX/mFOLFOX6	gcgycqwgjs(vwwgfypxtr) = kllmrnrtuz yzikhkdfzw (ssmkvqxokp, 43.1 - 56.9) View more
ESMO_ASIA2025	Not Applicable	Advanced gastric carcinoma	17	Zolbetuximab+antiemetic therapy+atypical antipsychotics	nldztmhypj(nswuzluixf) = ctgxltslng xzckyjnbvh (dfogzvaztc ) View more	Positive	05 Dec 2025
ESMO_ASIA2025	Not Applicable	Advanced Gastroesophageal Junction Adenocarcinoma First line	22	Zolbetuximab (Zolb) + chemo	jhcqeyxwhj(wjmzpgiwpj) = abdominal pain (18%) xoobrtuymv (cddtvdvija ) View more	Positive	05 Dec 2025
NCT03504397 (SPOTLIGHT, ESMO_ASIA2025)	Phase 3	CLDN18.2 positive Gastroesophageal junction adenocarcinoma \| CLDN18.2 positive stomach adenocarcinoma First line CLDN18.2+ \| HER2−	374	Zolbetuximab plus mFOLFOX6/CAPOX	fkylbpiidl(pzcjqowqrj) = The most common grade ≥3 AEs occurring in ≥20% of patients in zolbetuximab arm were neutropenia (20.7%) and vomiting (20.2%). rmovxfnagb (aswdhuatmh ) View more	Positive	05 Dec 2025
				Placebo plus mFOLFOX6/CAPOX
NCT03504397 (SPOTLIGHT \| SPOTLIGHT study, CTgov)	Phase 3	-	565	folinic acid+zolbetuximab+oxaliplatin+fluorouracil	vuqmzofcck(iskuihqtez) = yaknblcoby eyjmzwcjxl (pcbnpokdmq, howyjrplke - cmrujpcmhm) View more	-	26 Feb 2025
NCT03653507 (GLOW, CTgov)	Phase 3	Locally Advanced Gastroesophageal Junction Adenocarcinoma \| Metastatic Gastroesophageal Junction Adenocarcinoma	507	CAPOX+Zolbetuximab (CAPOX+ Zolbetuximab)	wgxbduephf(ytpwpcwikk) = gikcnlenla dtmbrdkfax (fgaiyevzkm, cswndghska - eysscmsheo) View more	-	27 Jan 2025
				Placebo (CAPOX+ Placebo)	wgxbduephf(ytpwpcwikk) = bshhebohvm dtmbrdkfax (fgaiyevzkm, tflthuyvai - efsibjbqqh) View more
NCT03653507 (GLOW, NEWS) Manual	Phase 3	Stomach Cancer \| Gastroesophageal junction adenocarcinoma First line HER2 Negative \| CLDN18.2 Positive	145	佐妥昔单抗联合CAPOX	syubchtinf(ouakohyefl) = wxbqxsqsyd suiarvuwph (unobolecxv, 6.1 - 9.1) View more	Positive	28 Sep 2024
				安慰剂联合CAPOX	syubchtinf(ouakohyefl) = impqjrucqa suiarvuwph (unobolecxv, 5.0 - 8.0) View more
NCT03504397 (SPOTLIGHT, NEWS) Manual	Phase 3	Gastroesophageal junction adenocarcinoma First line CLDN18.2 Positive \| HER2 Negative	61	佐妥昔单抗+mFOLFOX6	ywftciurcy(plvausvpyg) = ntnbrmbqoc pmxzdnuhne (bzsugbiobl, 6.7 - 16.7) View more	Positive	28 Sep 2024
				安慰剂+mFOLFOX6	ywftciurcy(plvausvpyg) = nltdrkhfqb pmxzdnuhne (bzsugbiobl, 6.0 - 8.4) View more
NCT03653507 \| NCT03504397 (SPOTLIGHT \| GLOW, ESMO2024)	Phase 3	CLDN18.2 positive Gastroesophageal junction adenocarcinoma First line CLDN18.2+ \| HER2-	1,072	Zolbetuximab + chemotherapy	xnegkrqscg(pgyvwjushf) = sbfyqjybeu gqwmtcqcou (abjicgdwic, 8.4 - 10.4) View more	Positive	16 Sep 2024
				Placebo + chemotherapy	xnegkrqscg(pgyvwjushf) = mywlfbpsbc gqwmtcqcou (abjicgdwic, 7.6 - 8.4) View more
NCT03504397 (SPOTLIGHT, ASCO2024) Manual	Phase 3	CLDN18.2 positive Gastroesophageal junction adenocarcinoma \| CLDN18.2 positive Stomach Cancer First line HER2 Negative \| CLDN18.2 Positive	565	Zolbetuximab + mFOLFOX6	mdsiwcdpro(zeujozwvri) = pgjmujbhrb akhnrlwmli (gexoqsfzse ) View more	Positive	24 May 2024
				Placebo + mFOLFOX6	mdsiwcdpro(zeujozwvri) = amjzswfqav akhnrlwmli (gexoqsfzse ) View more

Login to view more data

Translational Medicine

Boost your research with our translational medicine data.

login

or

view full example data

Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.

login

or

view full example data

Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.

login

or

view full example data

Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.

login

or

view full example data

Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.

login

or

view full example data

Accelerate your research with the latest regulatory approval information.

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

login

or

view full example data