The purpose of this study is to evaluate evorpacept with anti-cancer therapies in advanced/metastatic malignancies. The study is comprised of the following substudies:
* Metastatic HER2+ breast cancer (MBC) - single-arm substudy evaluating the efficacy, safety, and tolerability of evorpacept in combination with trastuzumab and chemotherapy in participants with HER2-positive metastatic breast cancer who have previously received trastuzumab-deruxtecan. This substudy is actively recruiting.
* Metastatic colorectal cancer (CRC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not recruiting.
* Recurrent/metastatic head and neck cancer (HNSCC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not recruiting.

Start Date28 Apr 2025

Sponsor / Collaborator

ALX Oncology, Inc.

NCT05467670

/ RecruitingPhase 2IIT

Safety and Efficacy of Anti-CD47, ALX148 in Combination with Liposomal Doxorubicin and Pembrolizumab in Patients with Recurrent Platinum-resistant Ovarian Cancer: Phase II Study

Immunotherapy with immune checkpoint inhibitors, including pembrolizumab, have emerged as a promising option in several solid cancers with durable effect and low toxicity profile. However, the benefit is limited to smaller subset of solid tumors. This trial involves the enhancement of current immune checkpoint-based immunotherapy with ALX148, an agent that inhibits CD47 (a trans-membrane protein that is highly expressed on the surface of many solid tumors as compared to normal cells).

Start Date30 Mar 2023

Sponsor / Collaborator

University of Pittsburgh

[+2]

NCT05868226

/ RecruitingPhase 1

PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I/Ib Platform Trial

I-SPY Phase I/Ib (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and/or other oncology-based trials in a timely manner.

Start Date15 Feb 2023

Sponsor / Collaborator

Quantumleap Healthcare Collaborative

100 Clinical Results associated with Evorpacept

100 Translational Medicine associated with Evorpacept

100 Patents (Medical) associated with Evorpacept

Literatures (Medical) associated with Evorpacept

01 Jul 2024·CURRENT OPINION IN ONCOLOGY

State of the art and upcoming trends in HER2-directed therapies in gastrointestinal malignancies

Review

Author: Lee, Jaeyop ; Ku, Geoffrey

Purpose of review:

This review critically evaluates the evolution and current status of human epidermal growth factor receptor 2 (HER2)-directed therapies in upper gastrointestinal (GI) malignancies, a timely and relevant inquiry given the dynamic shifts in therapeutic strategies over the past decade. Initial enthusiasm following the Trastuzumab for Gastric Cancer (ToGA) study's demonstration of trastuzumab's efficacy, however, encountered hurdles due to subsequent trials showing limited progress, underscoring the necessity for a reevaluation of therapeutic approaches and the exploration of novel agents.

Recent findings:

The review highlights significant breakthroughs in the form of immune checkpoint inhibitors and innovative therapeutic technologies, which have redefined treatment paradigms and shown promising efficacy in HER2-positive cases. Emerging treatments such as trastuzumab deruxtecan (T-DXd), zanidatamab and evorpacept further illustrate the ongoing efforts to leverage unique mechanisms of action for improved HER2-positive antitumor activity.

Summary:

The advancements in HER2-directed therapies underscore a pivotal era in the management of upper GI malignancies. These developments not only reflect the profound impact of integrating novel therapeutic combinations but also highlight the critical role of ongoing research in overcoming resistance mechanisms and tailoring treatment to individual disease profiles.

01 Jan 2024·TRANSFUSION MEDICINE AND HEMOTHERAPY

Evorpacept-Induced Interference and Application of a Novel Mitigation Agent, Evo-NR, in Pretransfusion Testing

Article

Author: Kim, Tae Yeul ; Yoon, Eungjun ; Kim, Hyungsuk ; Cho, Duck

Introduction: Evorpacept is a CD47-blocking agent currently being developed for the treatment of various cancers. Interference by evorpacept in pretransfusion compatibility testing has been reported at limited plasma concentrations. Although various mitigation strategies have been proposed, none are practical. This in vitro study assessed evorpacept-induced interference at extended concentrations and investigated the capability of a novel mitigation agent, Evo-NR. Methods: Antibody screening tests were performed on evorpacept-spiked plasma with (anti-E and anti-Jk^a) or without alloantibodies at evorpacept concentrations up to 2,000 μg/mL using manual gel cards and automated analyzers. Evorpacept-coated red blood cells (RBCs) (rr [ce/ce], Fy[a+b−], S−s+) were tested by direct antiglobulin testing (DAT) and antigen typing using anti-Fy^b and anti-S reagents at indirect antiglobulin testing (IAT) phase. Evo-NR was used to resolve the interference in plasma and RBC samples. Flow cytometry was used to assess the mitigation effects. Results: Evorpacept-spiked plasma showed panreactive interference in antibody screening tests using manual gel cards (2+ to 3+) and automated analyzers (4+). A carryover effect was also observed in the automated analyzers. The use of a 3- to 6-fold molar excess of Evo-NR effectively resolved the interference in the plasma and enabled accurate alloantibody identification. Although the reduction in evorpacept binding to RBCs was identified via flow cytometry, Evo-NR was incapable of resolving the serologic interference observed in DAT and antigen typing at IAT phase. Discussion: Evorpacept showed constant panreactivity and a carryover effect at high concentrations. Evo-NR successfully resolved the interference in the plasma samples and could be considered a practical and efficient mitigation solution. Implementation of Evo-NR has the potential to support RBC transfusion for patients undergoing evorpacept treatment.

01 Dec 2021·The Lancet. OncologyQ1 · MEDICINE

Evorpacept alone and in combination with pembrolizumab or trastuzumab in patients with advanced solid tumours (ASPEN-01): a first-in-human, open-label, multicentre, phase 1 dose-escalation and dose-expansion study

Q1 · MEDICINE

Article

Author: Patricia LoRusso ; Hyun Cheol Chung ; Keun-Wook Lee ; Hong I Wan ; Nehal J Lakhani ; Wells A Messersmith ; Pierre Squifflet ; Justin F Gainor ; Yung-Jue Bang ; Jaume Pons ; Frank Stephen Hodi ; Won Seog Kim ; Laura Q M Chow ; Jeeyun Lee ; Philip Fanning ; Sophia S Randolph ; Feng Jin ; Rafael Santana-Davila ; Tracy C Kuo

BACKGROUND:

Both innate and adaptive immune responses are important components of anticancer immunity. The CD47-SIRPα interaction could represent an important pathway used by tumour cells to evade immune surveillance. We aimed to evaluate the safety, pharmacokinetics, pharmacodynamics, and anticancer activity of evorpacept (also known as ALX148), a high-affinity CD47-blocking protein with an inactive IgG Fc region in patients with solid tumours.

METHODS:

We did a first-in-human, open-label, multicentre, phase 1 dose-escalation and dose-expansion study at nine hospitals and one clinic in the USA and Korea. Eligible patients for the dose-escalation and safety lead-in phases were aged 18 years or older with histological or cytological diagnosis of advanced or metastatic solid tumours with no available standard therapy, measurable or unmeasurable disease according to the Response Evaluation Criteria in Solid Tumors version 1.1, and an Eastern Cooperative Oncology Group performance status score of 0 or 1. In the dose-escalation phase, which used a 3 + 3 design, patients received intravenous evorpacept at either 0·3, 1, 3, or 10 mg/kg once per week in 21-day cycles, or 30 mg/kg once every other week in 28-day cycles. In the safety lead-in phase, patients were given the maximum tolerable dose of evorpacept from the dose-escalation phase plus either intravenous pembrolizumab (200 mg administered once every 3 weeks) or intravenous trastuzumab (8 mg/kg loading dose followed by 6 mg/kg once every 3 weeks). In the dose-expansion phase, additional patients aged 18 years or older with second-line or later-line advanced malignancies were enrolled into three parallel cohorts: those with head and neck squamous cell carcinoma (HNSCC) and those with non-small-cell lung cancer (NSCLC) were given the maximum tolerated dose of evorpacept plus intravenous pembrolizumab (200 mg administered once every 3 weeks), and patients with HER2-positive gastric or gastroesophageal junction cancer were given the maximum tolerated dose of evorpacept plus intravenous trastuzumab (8 mg/kg loading dose followed by 6 mg/kg once every 3 weeks) until disease progression, voluntary withdrawal from the study, or unacceptable toxicity. The primary endpoint was the maximum tolerated dose of evorpacept administered as a single agent and in combination with pembrolizumab or trastuzumab, measured by the occurrence of dose-limiting toxicities during the first cycle, and was assessed in all patients who had received at least one dose of evorpacept. Secondary outcomes included the safety, tolerability, and antitumour activity of evorpacept, alone or in combination with pembrolizumab or trastuzumab. The primary outcome, safety, and tolerability were assessed in all patients who had received at least one dose of evorpacept, and antitumour activity was assessed in those who recieved at least one dose of study treatment and underwent at least one post-baseline tumor assessment. This trial is registered with ClinicalTrials.gov, NCT03013218.

FINDINGS:

Between March 6, 2017, and Feb 21, 2019, 110 patients received single-agent evorpacept (n=28), evorpacept plus pembrolizumab (n=52), or evorpacept plus trastuzumab (n=30), and were included in the safety analysis. Median follow-up was 29·1 months (95% CI not calculable [NC]-NC) in the single-agent cohort, 27·0 months (25·1-28·8) in the evorpacept plus pembrolizumab cohort, and 32·7 months (27·0-32·7) in the evorpacept plus trastuzumab cohort. Two (7%) dose-limiting toxicities in the first cycle were reported in patients who received single-agent evorpacept; neutropenia with an associated infection in one patient with gastroesophageal junction cancer who received 3 mg/kg once per week, and thrombocytopenia with associated bleeding in one patient with pancreatic cancer who received 30 mg/kg once every other week. No maximum tolerated dose was reached; the maximum administered doses were 10 mg/kg once per week or 30 mg/kg once every other week. The 10 mg/kg once per week dose was used in the expansion cohorts in combination with pembrolizumab or trastuzumab. The most common grade 3 or worse treatment-related adverse events were thrombocytopenia with single-agent evorpacept (two [7%] patients) and evorpacept plus pembrolizumab (two [4%]), and thrombocytopenia (two [7%]) and neutropenia (two [7%]) with evorpacept plus trastuzumab. In patients who received single-agent evorpacept, four treatment-related serious adverse events were reported. Five serious treatment-related adverse events related to evorpacept plus pembrolizumab were reported, and one serious adverse event related to evorpacept plus trastuzumab was reported. In response-evaluable patients in the dose-escalation phase (n=15) receiving single-agent evorpacept once per week, four (27%) had a best overall response of stable disease (two received 0·3 mg/kg, one received 3 mg/kg, and one received 10 mg/kg); in the 11 patients who received single-agent evorpacept at the highest dose of 30 mg/kg once every other week, two (18%) had stable disease. In the dose-expansion cohort, overall responses were recorded in four (20·0%; 95% CI 5·7-43·7) of 20 patients with HNSCC who received evorpacept plus pembrolizumab, in one (5·0%; 0·1-24·9) of 20 patients with NSCLC who received evorpacept plus pembrolizumab, and in four (21·1%; 6·1-45·6) of 19 patients with gastric or gastroesophageal junction cancer who received evorpacept plus trastuzumab.

INTERPRETATION:

The safety findings support the use of evorpacept in combination with pembrolizumab or trastuzumab for patients with advanced solid tumours. Preliminary antitumour activity results support future investigation of evorpacept combined with pembrolizumab or trastuzumab in patients with HNSCC, gastric or gastroesophageal junction cancer, and NSCLC.

FUNDING:

ALX Oncology.

127

News (Medical) associated with Evorpacept

20 Aug 2025

·pipelinereview.com

ALX Oncology Doses First Patient in Phase 1 Dose Escalation Trial Evaluating ADC ALX2004 for the Treatment of EGFR-Expressing Solid Tumors

– A potential best- and first-in-class antibody-drug conjugate (ADC) for the treatment of EGFR-expressing solid tumors, ALX2004 is uniquely designed with every component optimized to maximize the therapeutic window -First-in-human trial of ALX2004 builds upon body of positive preclinical data demonstrating dose dependent anti-tumor activity and favorable safety profile -Initial safety data anticipated in first half 2026 SOUTH SAN FRANCISCO, CA, USA I August 19, 2025 I ALX Oncology Holdings Inc., (“ALX Oncology” or the”Company”) (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today announced that the first patient has been dosed in the Company’s Phase 1 clinical trial for ALX2004, a potential best- and first-in-class, epidermal growth factor receptor (EGFR) ADC that is being studied for the treatment of EGFR-expressing solid tumors. “Dosing of the first patient in the Phase 1 trial is an important milestone in ALX Oncology’s mission to develop a pipeline of best-in-class drugs; ALX2004 is our first ADC and treating our first patient with this drug is a significant step forward in fulfilling the potential of EGFR-targeted ADCs,” said Jason Lettmann, Chief Executive Officer at ALX Oncology. “Our preclinical data supports our conviction that ALX2004, with its optimized antibody, linker and payload, has the potential to overcome the toxicity challenges that have limited earlier generation EGFR-targeted ADCs. We look forward to enrolling this trial and expect to report initial safety data in the first half of 2026.” The Phase 1 clinical trial ( NCT07085091 ) is a first-in-human, open-label multicenter study evaluating ALX2004 in participants with advanced or metastatic select EGFR-expressing solid tumors. The study consists of a Phase 1a dose escalation portion followed by dose exploration, and a Phase 1b dose expansion. The dose escalation portion of the trial will enroll patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC) and colorectal cancer (CRC). All or a subset of these tumor types may be included in the dose exploration and expansion portions of the trial. ALX2004: Optimized for Success Based on Rigorous Drug Design Process Developed by ALX Oncology’s protein engineers utilizing the Company’s proprietary topoisomerase I inhibitor (Top1i) payload and linker payload platform, ALX2004 is a uniquely designed EGFR-targeted ADC where every component is optimized to maximize the therapeutic window by reducing toxicity. This includes an affinity-tuned EGFR antibody with a binding epitope distinct from approved EGFR antibodies. ALX2004 also has a proprietary Top1i payload engineered to offer enhanced bystander effect with improved linker stability for on-target delivery of payload. Robust Preclinical Data: Supporting Differentiation in EGFR-ADC Class Preclinical data supports ALX2004’s differentiated linker-payload construct, which has demonstrated superior stability versus other ADCs in its class, with dose-dependent activity and a favorable safety profile. In addition, ALX2004 has shown dose-dependent activity across a range of tumors, EGFR expression levels and mutations. Potent activity in tumor models supports its potential for treating patients with EGFR-expressing tumors. Preclinical model findings did not demonstrate EGFR-related skin toxicity at clinically relevant doses or payload-related interstitial lung disease, supportive of a potentially differentiated safety profile. About ALX Oncology ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action and entered the clinic in a Phase 1 trial in August 2025. More information is available at www.alxoncology.com and on LinkedIn @ ALX Oncology . SOURCE: ALX Oncology

Phase 1ADCImmunotherapy

19 Aug 2025

·ir.alxoncology.com

ALX Oncology Doses First Patient in Phase 1 Dose Escalation Trial Evaluating ADC ALX2004 for the Treatment of EGFR-Expressing Solid Tumors

- A potential best- and first-in-class antibody-drug conjugate (ADC) for the treatment of EGFR-expressing solid tumors, ALX2004 is uniquely designed with every component optimized to maximize the therapeutic window -First-in-human trial of ALX2004 builds upon body of positive preclinical data demonstrating dose dependent anti-tumor activity and favorable safety profile -Initial safety data anticipated in first half 2026 SOUTH SAN FRANCISCO, Calif., Aug. 19, 2025 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology" or the"Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today announced that the first patient has been dosed in the Company’s Phase 1 clinical trial for ALX2004, a potential best- and first-in-class, epidermal growth factor receptor (EGFR) ADC that is being studied for the treatment of EGFR-expressing solid tumors. "Dosing of the first patient in the Phase 1 trial is an important milestone in ALX Oncology’s mission to develop a pipeline of best-in-class drugs; ALX2004 is our first ADC and treating our first patient with this drug is a significant step forward in fulfilling the potential of EGFR-targeted ADCs," said Jason Lettmann, Chief Executive Officer at ALX Oncology. "Our preclinical data supports our conviction that ALX2004, with its optimized antibody, linker and payload, has the potential to overcome the toxicity challenges that have limited earlier generation EGFR-targeted ADCs. We look forward to enrolling this trial and expect to report initial safety data in the first half of 2026." The Phase 1 clinical trial (NCT07085091) is a first-in-human, open-label multicenter study evaluating ALX2004 in participants with advanced or metastatic select EGFR-expressing solid tumors. The study consists of a Phase 1a dose escalation portion followed by dose exploration, and a Phase 1b dose expansion. The dose escalation portion of the trial will enroll patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC) and colorectal cancer (CRC). All or a subset of these tumor types may be included in the dose exploration and expansion portions of the trial. ALX2004: Optimized for Success Based on Rigorous Drug Design Process Developed by ALX Oncology’s protein engineers utilizing the Company’s proprietary topoisomerase I inhibitor (Top1i) payload and linker payload platform, ALX2004 is a uniquely designed EGFR-targeted ADC where every component is optimized to maximize the therapeutic window by reducing toxicity. This includes an affinity-tuned EGFR antibody with a binding epitope distinct from approved EGFR antibodies. ALX2004 also has a proprietary Top1i payload engineered to offer enhanced bystander effect with improved linker stability for on-target delivery of payload. Robust Preclinical Data: Supporting Differentiation in EGFR-ADC Class Preclinical data supports ALX2004’s differentiated linker-payload construct, which has demonstrated superior stability versus other ADCs in its class, with dose-dependent activity and a favorable safety profile. In addition, ALX2004 has shown dose-dependent activity across a range of tumors, EGFR expression levels and mutations. Potent activity in tumor models supports its potential for treating patients with EGFR-expressing tumors. Preclinical model findings did not demonstrate EGFR-related skin toxicity at clinically relevant doses or payload-related interstitial lung disease, supportive of a potentially differentiated safety profile. About ALX Oncology ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action and entered the clinic in a Phase 1 trial in August 2025. More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objects of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology’s beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology’s actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology’s filings with the Securities and Exchange Commission (SEC), including ALX Oncology’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Relations Contact: Elhan Webb, CFA, IR Consultant ewebb@alxoncology.com Media Contact: Audra Friis, Sam Brown Healthcare Communications audrafriis@sambrown.com (917) 519-9577

Phase 1ADC

01 Jul 2025

·www.biospace.com

Pfizer Ends Mid-Stage Trial for CD47 Blood Cancer Drug, Citing Recruitment Problems

iStock, mohd izzuan Pfizer insists that the discontinuation of the Phase II study was due to recruitment difficulties and was not linked to maplirpacept’s safety or efficacy. Pfizer has terminated a Phase II trial that was evaluating its investigational fusion protein maplirpacept in diffuse large B-cell lymphoma after running into recruitment challenges. According to an update to a federal clinical trials database , the study was dropped because of the “inability to recruit the planned number of subjects.” Only six had been enrolled into the trial since it began in August 2023. “The decision was not based on any safety and/or efficacy concerns,” the update noted. In a statement to Endpoints News , a spokesperson for Pfizer confirmed that “recruiting challenges” led to the call to discontinue the trial. Designed to be delivered intravenously, maplirpacept is a recombinant fusion protein that targets CD47, a cell surface ligand that binds to immune cells and prevents phagocytosis. CD47 is present at low levels in almost all cells of the body, but is overexpressed in blood cancer cells, in turn allowing them to evade immune activity. CD47 has been linked to worse clinical outcomes and blocking this protein helps boost both the innate and adaptive immune responses, according to Pfizer’s website. Pfizer gained ownership of maplirpacept with the $2.26 billion acquisition of Trillium Therapeutics in August 2021. In the statement to Endpoints , the company spokesperson said that Pfizer continues to study maplirpacept in other blood cancers, including multiple myeloma. The pharma also has a Phase I/II trial of the asset, combined with Roche’s Columvi, in patients with relapsed or refractory diffuse large B-cell lymphoma. The clinicaltrials.gov webpage for this study indicates that it is currently recruiting , with a primary completion date of September 2026. The discontinuation of maplirpacept’s mid-stage study represents yet another setback for the embattled CD47 space. Earlier this year, ALX Oncology reported that its CD47 blocker evorpacept, in combination with Merck’s Keytruda, failed two mid-stage studies in metastatic or unresectable recurrent head and neck cancer. Arguably the most high-pro failure, however, is Gilead’s magrolimab, which was finally completely discontinued last year after a troubled run. In early 2022, the FDA slapped partial clinical holds on several studies of magrolimab after detecting an imbalance of serious toxicities in treated patients. Then, in July 2023, the pharma terminated a late-stage study for the drug in myelodysplastic syndromes, citing futility.

AcquisitionPhase 2Clinical StudyImmunotherapy

100 Deals associated with Evorpacept

External Link

KEGG	Wiki	ATC	Drug Bank
D12193	-	-	-

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
HER2-expressing Gastric Adenocarcinoma	Phase 3	United States	ALX Oncology, Inc.	15 Jan 2022
HER2-expressing Gastric Adenocarcinoma	Phase 3	United States	Eli Lilly & Co.	15 Jan 2022
HER2-expressing Gastric Adenocarcinoma	Phase 3	Japan	Eli Lilly & Co.	15 Jan 2022
HER2-expressing Gastric Adenocarcinoma	Phase 3	Japan	ALX Oncology, Inc.	15 Jan 2022
HER2-expressing Gastric Adenocarcinoma	Phase 3	Australia	ALX Oncology, Inc.	15 Jan 2022
HER2-expressing Gastric Adenocarcinoma	Phase 3	Australia	Eli Lilly & Co.	15 Jan 2022
HER2-expressing Gastric Adenocarcinoma	Phase 3	Belgium	ALX Oncology, Inc.	15 Jan 2022
HER2-expressing Gastric Adenocarcinoma	Phase 3	Belgium	Eli Lilly & Co.	15 Jan 2022
HER2-expressing Gastric Adenocarcinoma	Phase 3	Czechia	ALX Oncology, Inc.	15 Jan 2022
HER2-expressing Gastric Adenocarcinoma	Phase 3	Czechia	Eli Lilly & Co.	15 Jan 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05025800 (AACR2025) Manual	Phase 1	Non-Hodgkin Lymphoma	20	Evorpacept + lenalidomide + rituximab	majxygbgvn(feamocwkla) = pkfnkhkacj xhgbpulvua (evjnnpfwhs ) View more	Positive	29 Apr 2025
NCT04675294 (ASPEN-03, Company_Website) Manual	Phase 2	Advanced Head and Neck Squamous Cell Carcinoma First line PD-L1 Positive	-	Evorpacept + pembrolizumab	nqsbmmasqh(svpklqooow) = Not Meet Primary Endpoints xjmqgdysae (zfyluzhoee ) Not Met	Negative	25 Apr 2025
				pembrolizumab
NCT04675333 (ASPEN-04, Company_Website) Manual	Phase 2	Advanced Head and Neck Squamous Cell Carcinoma	-	evorpacept + pembrolizumab + chemotherapy	jgfuktludj(vqclwodmwh) = Not Meet Primary Endpoints. cwjcuighmp (bfvutucrtl ) Not Met	Negative	25 Apr 2025
				pembrolizumab + chemotherapy
NCT05002127 (ASPEN-06, Corporate Publications) Manual	Phase 2/3	HER2 positive Gastrooesophageal junction cancer \| HER2-positive gastric cancer HER2 Positive	127	Evorpacept + Trastuzumab + Ramucirumab + Paclitaxel	msbmlnfpov(jcxsequbvb) = mjalunvdgh rypwcswwnk (zuxebshjmu, 29.0 - 54.4) View more	Positive	23 Jan 2025
				Trastuzumab + Ramucirumab + Paclitaxel	msbmlnfpov(jcxsequbvb) = qpyolmkkga rypwcswwnk (zuxebshjmu, 16.3 - 39.1) View more
NCT05002127 (ASPEN-06, ASCO_GI2025) Manual	Phase 2/3	HER2 Positive Gastroesophageal Adenocarcinoma \| HER2-positive gastric cancer HER2+	127	EvorpaceptEvorpacept (ALX148) + Trastuzumab (T) + Ramucirumab (R) + Paclitaxel (P)	yvapjoqbnl(twgtivysyk) = kakklcwzsr alqtdwofzx (rumiqbtnqi ) View more	Positive	23 Jan 2025
				Trastuzumab (T) + Ramucirumab (R) + Paclitaxel (P)	yvapjoqbnl(twgtivysyk) = ajtuebqtew alqtdwofzx (rumiqbtnqi ) View more
NCT05002127 (ASPEN-06, Company_Website) Manual	Phase 2/3	HER2-positive gastric cancer \| HER2 positive Gastroesophageal Junction Adenocarcinoma HER2 Positive	127	Evorpacept + trastuzumab + CYRAMZA + paclitaxel	pywljievfp(inbjlfsmfy) = ieabuwekwu fbemoqzzoi (aqwxiioowb ) View more	Positive	31 Jul 2024
				Trastuzumab + CYRAMZA + paclitaxel	pywljievfp(inbjlfsmfy) = aynquywzzb fbemoqzzoi (aqwxiioowb ) View more
NCT05167409 (ASCO2024) Manual	Phase 2	Metastatic Microsatellite Stable Colorectal Carcinoma Microsatellite Stable (MSS)	16	Evorpacept (E) 15 mg/kgcetuximabpembrolizumab	daweoonzic(yevqhycjyy) = hnrbdhijtv thzkpxqsft (sstgpfvryz ) View more	Negative	24 May 2024
NCT05524545 (ASCO2024) Manual	Phase 1	Locally Advanced Urothelial Carcinoma \| Metastatic urothelial carcinoma	20	Evorpacept 20 mg/kgenfortumab vedotin	rgiuhlyrrn(xtxvnsabfs) = Not observed. otrnjsnhxs (jszkjshgfd ) View more	Positive	24 May 2024
NCT05025800 (AACR2024) Manual	Phase 1	Non-Hodgkin Lymphoma	20	Evorpacept+rituximab+lenalidomide	ddpyphkjui(lmbytbjtsv) = jajrbhtwmt tbpgmdkvvs (bsmxnjybsf ) View more	Positive	05 Apr 2024
NCT05002127 (ASPEN-06, NEWS) Manual	Phase 2	Metastatic HER2 positive gastroesophageal junction cancer \| HER2-positive gastric cancer Second line HER2 Positive	54	Evorpacept 30 mg/kg+trastuzumab + CYRAMZA + paclitaxel	zkjdjxgmvk(cyqajcttfm) = iknbzuapdf etqfycazde (ezamqolaaf ) View more	Positive	03 Oct 2023
				trastuzumab + CYRAMZA + paclitaxel	zkjdjxgmvk(cyqajcttfm) = dzegsbmxsn etqfycazde (ezamqolaaf ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

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.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis