Efficacy and Safety of Socazolimab Combined With Chemotherapy With or Without Bevacizumab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer: A Randomized, Double-blind, Placebo-controlled Phase III Study

The goal of this clinical trial is to evaluate the efficacy and safety of Socazolimab combined with chemotherapy with or without bevacizumab as first-Line treatment in persistent, recurrent, or metastatic cervical cancer. The main question it aims to answer is:
Does Socazolimab combined with chemotherapy with or without bevacizumab better benefit patients with persistent, recurrent, or metastatic cervical cancer as first-line treatment compared with placebo combined with chemotherapy with or without bevacizumab.
Participants will be treated with Socazolimab/placebo + chemotherapy ± bevacizumab) for 6
8 cycles (Q3w), following maintenance treatment of Socazolimab/placebo (Q3w).

Start Date01 Sep 2024

Sponsor / Collaborator

Lee's Pharmaceutical Holdings Ltd.

ChiCTR2300078237 / SuspendedEarly Phase 1IIT

A single-arm exploratory clinical study of nab-paclitaxel combined with subcutaneous PD-L1 monoclonal antibody in the treatment of advanced and posterior triple-negative breast cancer

Start Date01 Dec 2023

Sponsor / Collaborator-

CTR20210605 / TerminatedPhase 1/2

一线治疗失败后局部进展或转移性黑色素瘤中Pexa-Vec（痘苗GM-CSF/TK灭活病毒）联合重组全人抗PD-L1单克隆抗体（ZKAB001）的Ib/II期、开放、对照临床研究

[Translation] A Phase Ib/II, open-label, controlled clinical study of Pexa-Vec (vaccinia GM-CSF/TK inactivated virus) combined with a recombinant fully human anti-PD-L1 monoclonal antibody (ZKAB001) in locally advanced or metastatic melanoma after failure of first-line therapy

主要目的： Ib期：评价在一线治疗失败的局部进展或转移性黑色素瘤患者中Pexa-Vec联合ZKAB001治疗的安全性和II期推荐剂量（RP2D）； II期：评价在一线治疗失败的局部进展或转移性黑色素瘤患者中ZKAB001联合Pexa-Vec II期推荐剂量或ZKAB001单药治疗的客观缓解率（ORR）和无进展生存期（PFS）。次要目的： 1) ZKAB001联合Pexa-Vec及ZKAB001单药治疗一线治疗失败的局部进展或转移性黑色素瘤患者的总生存期（OS）、疾病控制率（DCR）和缓解持续时间（DOR）； 2) 评价Pexa-Vec联合ZKAB001治疗一线治疗失败的局部进展或转移性黑色素瘤患者的安全性； 3) 评价肿瘤组织PD-L1的表达水平与临床效应关系； 4) 评价Pexa-vec治疗前后肿瘤组织免疫微环境的变化（CD8+表达水平）。

[Translation]

Main objectives: Phase Ib: To evaluate the safety and Phase II recommended dose (RP2D) of Pexa-Vec combined with ZKAB001 in patients with locally advanced or metastatic melanoma who have failed first-line treatment; Phase II: To evaluate the objective response rate (ORR) and progression-free survival (PFS) of ZKAB001 combined with Pexa-Vec Phase II recommended dose or ZKAB001 monotherapy in patients with locally advanced or metastatic melanoma who have failed first-line treatment. Secondary objectives: 1) To evaluate the overall survival (OS), disease control rate (DCR) and duration of response (DOR) of patients with locally advanced or metastatic melanoma who have failed first-line treatment with ZKAB001 combined with Pexa-Vec and ZKAB001 alone; 2) To evaluate the safety of Pexa-Vec combined with ZKAB001 in patients with locally advanced or metastatic melanoma who have failed first-line treatment; 3) To evaluate the relationship between the expression level of PD-L1 in tumor tissue and clinical effect; 4) To evaluate the changes in the immune microenvironment of tumor tissue before and after Pexa-vec treatment (CD8+ expression level).

Start Date27 Sep 2021

Sponsor / Collaborator

Zhaoke (Guangzhou) Oncology Pharmaceutical Ltd.

100 Clinical Results associated with Socazolimab

100 Translational Medicine associated with Socazolimab

100 Patents (Medical) associated with Socazolimab

Literatures (Medical) associated with Socazolimab

29 Oct 2024·PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

O-GlcNAcylation of enolase 1 serves as a dual regulator of aerobic glycolysis and immune evasion in colorectal cancer

Article

Author: Li, Jingchao ; Yi, Wen ; Hsieh-Wilson, Linda C. ; Chai, Siyuan ; Zhu, Qiang ; Fan, Zhiya ; Lin, Bingyi ; Wang, Yong ; Wu, Liming ; Hu, Jiating ; Qin, Weijie ; Sun, Haofan

Aerobic glycolysis and immune evasion are two key hallmarks of cancer. However, how these two features are mechanistically linked to promote tumor growth is not well understood. Here, we show that the glycolytic enzyme enolase-1 (ENO1) is dynamically modified with an O -linked β- N -acetylglucosamine (O-GlcNAcylation), and simultaneously regulates aerobic glycolysis and immune evasion via differential glycosylation. Glycosylation of threonine 19 (T19) on ENO1 promotes its glycolytic activity via the formation of active dimers. On the other hand, glycosylation of serine 249 (S249) on ENO1 inhibits its interaction with PD-L1, decreases association of PD-L1 with the E3 ligase STUB1, resulting in stabilization of PD-L1. Consequently, blockade of T19 glycosylation on ENO1 inhibits glycolysis, and decreases cell proliferation and tumor growth. Blockade of S249 glycosylation on ENO1 reduces PD-L1 expression and enhances T cell–mediated immunity against tumor cells. Notably, elimination of glycosylation at both sites synergizes with PD-L1 monoclonal antibody therapy to promote antitumor immune response. Clinically, ENO1 glycosylation levels are up-regulated and show a positive correlation with PD-L1 levels in human colorectal cancers. Thus, our findings provide a mechanistic understanding of how O-GlcNAcylation bridges aerobic glycolysis and immune evasion to promote tumor growth, suggesting effective therapeutic opportunities.

01 Jun 2024·Current cancer drug targets

IR-780 Dye-based Targeting of Cancer-associated Fibroblasts Improves Cancer Immunotherapy by Increasing Intra-tumoral T Lymphocytes Infiltration

Article

Author: Chen, Hongdan ; Yang, Wei ; Zhang, Can ; Tan, Xu ; Chen, Zelin ; Chen, Wanchao ; Qu, Langfan ; Shi, Chunmeng ; Zheng, Jiancheng

Background:::

Immune-checkpoint inhibitors (ICIs) against programmed death (PD)-1/PD-L1 pathway immunotherapy have been demonstrated to be effective in only a subset of patients with cancer, while the rest may exhibit low response or may develop drug resistance after initially responding. Previous studies have indicated that extensive collagen-rich stroma secreted by cancer-associated fibroblasts (CAFs) within the tumor microenvironment is one of the key obstructions of the immunotherapy for some tumors by decreasing the infiltrating cytotoxic T cells. However, there is still a lack of effective therapeutic strategies to control the extracellular matrix by targeting CAFs.

Methods:::

The enhanced uptake of IR-780 by CAFs was assessed by using in vivo or ex vivo nearinfrared fluorescence imaging, confocal NIR fluorescent imaging, and CAFs isolation testing. The fibrotic phenotype down-regulation effects and in vitro CAFs killing effect of IR-780 were tested by qPCR, western blot, and flow cytometry. The in vivo therapeutic enhancement of anti-PD-L1 by IR-780 was evaluated on EMT6 and MC38 subcutaneous xenograft mice models.

Results:::

IR-780 has been demonstrated to be preferentially taken up by CAFs and accumulate in the mitochondria. Further results identified low-dose IR-780 to downregulate the fibrotic phenotype, while high-dose IR-780 could directly kill both CAFs and EMT6 cells in vitro. Moreover, IR-780 significantly inhibited extracellular matrix (ECM) protein deposition in the peri-tumoral stroma on subcutaneous EMT6 and MC38 xenografts, which increased the proportion of tumor-infiltrating lymphocytes (TILs) in the deep tumor and further promoted anti-PD-L1 therapeutic efficacy.

Conclusion:::

This work provides a unique strategy for the inhibition of ECM protein deposition in the tumor microenvironment by targeted regulating of CAFs, which destroys the T cell barrier and further promotes tumor response to PD-L1 monoclonal antibody. IR-780 has been proposed as a potential therapeutic small-molecule adjuvant to promote the effect of immunotherapy.

01 Apr 2024·The Annals of pharmacotherapy

Atezolizumab as the First Systemic Therapy Approved for Alveolar Soft Part Sarcoma

Review

Author: Mancuso, David ; Orr, Roger ; Vuskovich, Theresa ; Elgawly, Mariam ; Seligson, Nathan D. ; Bergsma, Emilie J.

Objective:

The objective was to review the pharmacology, efficacy, and safety of atezolizumab (Tecentriq) for the treatment of adult and pediatric patients aged 2 years and older with unresectable or metastatic alveolar soft part sarcoma (ASPS).

Data Sources:

A literature search was conducted using PubMed and MEDLINE databases, published abstracts, and ongoing studies from ClinicalTrials.gov between January 1, 1981, and May 31, 2023. Keywords included atezolizumab, Tecentriq, MPDL3280, immunotherapy, PD-L1, PD-1, pediatrics, sarcoma, and ASPS.

Study selection and data extraction:

All English-language studies involving atezolizumab for ASPS were included and discussed.

Data synthesis:

Atezolizumab is an anti-programmed death-ligand 1 (PD-L1) monoclonal antibody designed to block the interaction between PD-L1 and the programmed cell death protein 1 (PD-1) receptor. Atezolizumab was granted approval by the FDA specifically for ASPS based on a phase II clinical trial in adult and pediatric patients (n = 49), which reported an overall response rate of 24% and a durable response rate at 6 and 12 months of 67% and 42%, respectively. Common grade 3/4 adverse reactions include musculoskeletal pain (8%), followed by hypertension (6%), weight gain (6%), headache (4%), and dizziness (4%).

Relevance to patient care and clinical practice in comparison with existing drugs:

Advanced ASPS is a high-risk disease with limited treatment options. Atezolizumab appears to be a viable treatment option in ASPS demonstrating clinical efficacy and a manageable toxicity profile.

Conclusions:

With no other treatments that are FDA approved specifically for ASPS, and few demonstrating efficacy in the advanced setting, the approval of atezolizumab, including the first approval for pediatric patients, represents a landmark improvement to the therapeutic arsenal against this rare disease.

News (Medical) associated with Socazolimab

01 Nov 2024

·www.prnewswire.com

The Phase III clinical trial application for first-line treatment of extensive disease small cell lung cancer with Chiauranib has been approved

SHENZHEN, China, Nov. 1, 2024 /PRNewswire/ -- On November 1, Shenzhen Chipscreen Biosciences Co., Ltd. (hereinafter referred to as "Chipscreen Biosciences") and its wholly-owned subsidiary Chengdu Chipscreen Pharmaceutical Ltd., received the "Drug Clinical Trial Approval Notice" approved by the National Medical Products Administration. The company's self-developed original new drug, Chiauranib, combined with PD - (L) 1 monoclonal antibody and standard chemotherapy for the first-line treatment of extensive stage small cell lung cancer, has been approved for phase III clinical trials. Extensive disease small cell lung cancer (ES-SCLC), as a highly aggressive subtype of lung cancer, has long been a huge challenge in the field of treatment. In recent years, chemo-immunotherapy has greatly improved the survival outcomes of patients with small cell lung cancer. However, compared to other types of tumors, there is still great room for improvement in the long-term survival of patients with small cell lung cancer. Chiauranib has a multi pathway pharmacological mechanism and has unique anti-tumor activity against neuroendocrine tumors such as small cell lung cancer. At the same time, it can produce synergistic effects with immunotherapy and chemotherapy through its dual effects of anti-angiogenesis and immune regulatory activity. On the basis of first-line chemo-immunotherapy, the introduction of the new regimen of Chiauranib is expected to further improve the long-term survival of patients with extensive stage small cell lung cancer, demonstrating enormous clinical treatment potential. In addition to the approved Phase III clinical trial, the phase III clinical trial of Chiauranib monotherapy for the later-line treatment of small cell lung cancer has been completed and the Pre NDA is currently under communication. The phase III clinical trial of Chiauranib combined with chemotherapy for ovarian cancer, and the phase II clinical trial of single or combined treatment for triple negative breast cancer, soft tissue sarcoma and pancreatic cancer are also being progressed. In terms of overseas clinical trials, the phase Ib/II clinical trial of Chiauranib monotherapy for small cell lung cancer / solid tumor is in progress in the United States. About Chiauranib Chiauranib is a novel molecular entity independently designed and developed by the Chipscreen Biosciences, with global patent protection. It is a selective inhibitor of Aurora B, a key mitotic regulator. Additionally, Chiauranib targets VEGFR to inhibit tumor angiogenesis, and blocks CSF1R and DDR1 pathways to reduce the infiltration and activity of immunosuppressive cells, thereby enhancing tumor immune microenvironment. Its unique Aurora B inhibitory activity specifically targets neuroendocrine tumors, such as SCLC, making it a novel small molecule anti-tumor drug candidate. Chiauranib exerts a comprehensive anti-tumor effect by a triple-pathway mechanism that simultaneously inhibits tumor angiogenesis, prevents tumor cell mitosis, and modulates the tumor microenvironment. Chiauranib has outperformed drugs with a similar mechanism in overall efficacy and safety profile. About Chipscreen Chipscreen Biosciences is an innovative drug company driven by core technologies with globally competitive pipelines. As a pioneer in drug innovation & development in China, adhering to the concept of "Constant Innovation for Life", we focus on developing revolutionary innovative drugs with new mechanisms of action, to address patients' pressing clinical needs. Our complete industry chain that covers early exploratory discovery through commercialization allows us to provide innovative Chinese drugs for patients worldwide. With a global development strategy based on early-stage research in China, Chipscreen Biosciences has leveraged the top scientists and teams with extensive experience in related fields from the Shenzhen Small Molecule Early R&D Center and Chengdu Small Molecule Early R&D Center to create an integrated technology platform based on AI-driven design and chemical genomics, which spanned the whole process from basic science to clinical translation. We have successfully developed first-in-class and best-in-class innovative drugs. Currently, 2 drugs with 6 indications have been marketed worldwide. In addition, we have launched a number of R&D projects with differentiated advantages and global competitiveness in the five major areas, including malignant tumors, metabolic diseases, autoimmune diseases, central nervous system diseases, and antivirals. Chipscreen Biosciences has formed a global industrial layout consisting of Shenzhen Head Office/R&D Center/GMP production base, Chengdu Regional Head Office/R&D Center/GMP production base, Beijing Branch, Shanghai Branch, and Chipscreen Biosciences (USA) Co., Ltd. Meanwhile, as one of the first batches of national "innovative drug incubation bases" and national high-tech enterprises, Chipscreen Biosciences has independently undertaken many national "863" plans and national major science and technology projects, such as "10th five-year plan", "11th five-year plan", "12th five-year plan" and "13th five-year plan", and National Science and Technology primary Project for Innovative Drug Development. We have filed over 680 invention patents in China and worldwide, with over 200 granted. SOURCE Shenzhen Chipscreen Biosciences Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyPhase 3Phase 2Drug Approval

01 Nov 2024

·www.prnewswire.com

Akeso Announces First Patient Enrollment in Phase 3 Trial of Ivonescimab Combination as First-Line Therapy for Biliary Tract Tumors, Compared to Durvalumab

HONG KONG, Oct. 31, 2024 /PRNewswire/ -- Akeso Biopharma (9926.HK) is pleased to announce the successful enrollment of the first patient in the AK112-309 trial, a randomized, controlled, multicenter Phase III registration study for biliary track tumor. This trial is designed to compare the ivonescimab combined regimen, a PD-1/VEGF bispecific antibody internally developed by Akeso, with the durvalumab (PD-L1) combined regimen for the first-line treatment of advanced biliary tract cancers (BTC). The primary endpoint of the AK112-309 study is overall survival (OS). This study represents the sixth registrational Phase III clinical trial featuring ivonescimab, with a PD-1/L1 monoclonal antibody as the comparator. It underscores Akeso's commitment to advancing the field of cancer immunotherapy and establishing a global standard of care for cancer treatment. Furthermore, it highlights Akeso's capability to maximize the number of cancer patients globally that can benefit from its product portfolio through a strategic approach to clinical development. Previously, the positive results from a Phase II clinical study of ivonescimab in combination with chemotherapy for the first-line treatment of BTC were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The findings demonstrated that the ivonescimab regimen exhibits significant antitumor activity and a good safety profile in BTC. The objective response rate (ORR), as assessed by investigators, was 63.6%, with an ORR of 77.8% specifically for patients with gallbladder cancer. The disease control rate (DCR) reached 100%. The median progression-free survival (PFS) was 8.5 months, with a 6-month PFS rate of 84.4%. Furthermore, the median overall survival (OS) was 16.8 months, with a 9-month OS rate of 81.8%. Notably, patients with gallbladder cancer exhibited a median OS of 16.8 months. At the time of the analysis, the median follow-up time was 13.8 months. The study included patients with a median age of 65.3 years, of whom 81.8% had an ECOG performance status of 1. All enrolled patients are presented with unresectable tumors, and 40.9% were diagnosed with gallbladder cancer. Biliary tract malignancies, originating from the bile ducts and gallbladder, represent a group of highly heterogeneous cancers associated with a poor prognosis. At the time of diagnosis, approximately 50% of biliary tract cancer patients are already in advanced stages, often with a survival period of less than one year. Although PD-1/L1 inhibitors in combination with chemotherapy have been approved as a first-line treatment for advanced biliary tract cancer, the overall survival benefit has been limited, particularly for patients with gallbladder cancer. The initial positive clinical data from the ivonescimab regimen indicates a possible advancement in the therapeutic landscape for these challenging malignancies. About Ivonescimab (AK112/SMT112) Ivonescimab is a novel global first-in-class PD-1/VEGF bi-specific immunotherapy drug independently developed by Akeso. Ivonescimab is known as SMT112 in Summit Therapeutics's license territories, including the United States, Canada, Europe, Japan, Central America, South America, the Middle East and Africa. Ivonescimab was granted marketing approval by NMPA for the treatment of EGFR mutated locally advanced or metastatic non-squamous NSCLC patients who have progressed after EGFR TKI treatment. Currently, ivonescimab's first indication has been approved in China, and Akeso is conducting 6 registrational trials versus anti-PD-1/L1 therapeutics. Akeso is also conducting multiple clinical trials of ivonescimab covering 17 indications including gastrointestinal cancer, hepatocellular carcinoma and colorectal cancer. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions.With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 22 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). Additionally, 5 new drugs are commercially available, and 5 new drugs across 7 indications are currently under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical ResultImmunotherapyDrug ApprovalASCO

04 Oct 2024

·pipelinereview.com

Arcus Biosciences Announces Clinical Trial Collaboration Agreement to Evaluate Casdatifan in Combination with Volrustomig in Renal Cell Carcinoma

HAYWARD, CA, USA I October 02, 2024 I Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, today announced a clinical trial collaboration agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) to evaluate casdatifan (AB521), Arcus’s investigational HIF-2a inhibitor, in combination with volrustomig, AstraZeneca’s investigational PD-1/CTLA-4 bispecific antibody, in patients with ccRCC. “We believe casdatifan has best-in-class potential, based on the observed PK and PD profiles and the emerging clinical data from our ARC-20 study in patients with ccRCC,” said Terry Rosen, Ph.D., chief executive officer of Arcus. “This agreement will enable Arcus and AstraZeneca to collaborate and assess the potential for the novel combination of casdatifan with volrustomig to improve outcomes for patients with ccRCC.” “Renal cell carcinoma is a known CTLA-4-responsive tumor type, and our first-in-human study with volrustomig monotherapy demonstrated encouraging efficacy in first-line advanced ccRCC,” said Cristian Massacesi, chief medical officer and oncology chief development officer, AstraZeneca. “We are excited by the potential to build on this by combining HIF-2a inhibition with volrustomig to drive deeper and more durable responses for patients.” As part of this collaboration, AstraZeneca will sponsor and operationalize a study to evaluate the safety and early efficacy of the casdatifan plus volrustomig combination in patients with advanced ccRCC. This is the second clinical collaboration between Arcus and AstraZeneca. In 2020, the companies announced a clinical collaboration for PACIFIC-8, a registrational Phase 3 study of domvanalimab, an Fc-silent anti-TIGIT antibody, added to backbone global standard-of-care durvalumab, an anti-PD-L1 antibody, in patients with unresectable Stage III non-small cell lung cancer. Under the Gilead and Arcus collaboration agreement, Gilead has the right to opt-in to development and commercialization for casdatifan after Arcus’s delivery of a qualifying data package. About Casdatifan (AB521) Casdatifan is a small-molecule inhibitor of HIF-2a, a transcription factor involved in oxygen sensing in multiple organs as well as in tumors. Clear cell RCC is almost universally associated with HIF-2a dysregulation as a result of genetic abnormalities in the VHL pathway. This creates a situation of pseudohypoxia and the abnormal increase in HIF-2a-mediated expression of a wide array of proteins involved in cancer cell proliferation and survival, treatment resistance and angiogenesis. Casdatifan is being evaluated in ARC-20, a Phase 1/1b study in cancer patients, and STELLAR-009, a Phase 1b/2 study in combination with zanzalintinib in patients with advanced solid tumors, including ccRCC. Casdatifan and domvanalimab are investigational molecules. Approval from any regulatory authority for any use of these molecules globally has not been received, and their safety and efficacy have not been established. About RCC According to the American Cancer Society, kidney cancer is among the top 10 most commonly diagnosed forms of cancer among both men and women in the U.S., and an estimated 81,600 Americans will be diagnosed with kidney cancer in 2024. Clear cell RCC is the most common type of kidney cancer in adults. If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 15%. In 2022, approximately 32,200 patients with advanced kidney cancer required systemic therapy in the U.S., with over 20,000 patients receiving first-line treatment. About Arcus Biosciences Arcus Biosciences is a clinical-stage, global biopharmaceutical company developing differentiated molecules and combination medicines for people with cancer. In partnership with industry collaborators, patients and physicians around the world, Arcus is expediting the development of first- or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has expedited the development of multiple investigational medicines into clinical studies, including new combination approaches that target TIGIT, PD-1, HIF-2a, CD73, dual A2a/A2b receptor, CD39, and AXL. For more information about Arcus Biosciences’ clinical and preclinical programs, please visit www.arcusbio.com . SOURCE: Arcus Biosciences

Phase 3License out/in

100 Deals associated with Socazolimab

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Metastatic Cervical Carcinoma	CN	Zhaoke (Guangzhou) Oncology Pharmaceutical Ltd.	19 Dec 2023
Recurrent Cervical Cancer	CN	Zhaoke (Guangzhou) Oncology Pharmaceutical Ltd.	19 Dec 2023

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Extensive stage Small Cell Lung Cancer	NDA/BLA	CN	Zhaoke (Guangzhou) Oncology Pharmaceutical Ltd.	13 Jul 2024
Metastatic Carcinoma to the Uterine Cervix	Phase 3	-	Lee's Pharmaceutical Holdings Ltd.	01 Sep 2024
Osteosarcoma	Phase 3	-	Lee's Pharmaceutical Holdings Ltd.	01 Jun 2020
Metastatic melanoma	Phase 2	CN	Zhaoke (Guangzhou) Oncology Pharmaceutical Ltd.	27 Sep 2021
Esophageal Squamous Cell Carcinoma	Phase 2	CN	Zhaoke (Guangzhou) Oncology Pharmaceutical Ltd.	19 Nov 2020
Metastatic urothelial carcinoma	Phase 2	CN	Lee's Pharmaceutical Holdings Ltd.	10 Oct 2018
Transitional Cell Carcinoma	Phase 2	CN	Lee's Pharmaceutical Holdings Ltd.	10 Oct 2018
Biliary Tract Neoplasms	Phase 1	CN	Zhaoke (Guangzhou) Oncology Pharmaceutical Ltd.	24 Mar 2021
Advanced Urothelial Carcinoma	Phase 1	CN	Zhaoke (Guangzhou) Oncology Pharmaceutical Ltd.	14 Sep 2020
Neoplasms	Preclinical	US	Sorrento Therapeutics, Inc.	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SITC2023	Not Applicable	Melanoma	-	Snail mucus	kjecaaapph(mjtcvhnpcy) = PD-L1 expression was upregulated in the snail mucus-treated A375 cells hpkfilrinr (xxqdivherm ) View more	Positive	02 Nov 2023
NCT04346914 (Pubmed)	Phase 1	Extensive stage Small Cell Lung Cancer First line	20	Socazolimab	xlariphiga(msrbcujmnd) = wowqcqvhne hcrxnxhlui (tbdahtqzmb, 45.72% - 88.11) View more	-	01 Apr 2023
NCT03676959 (Pubmed)	Phase 1	Metastatic Carcinoma to the Uterine Cervix	-	Socazolimab 5mg/kg	nejmyptnww(lutrrafmel) = orrbwtuazb kvmnzhofwg (cglaektwis, 8.7 - 24.5) View more	Positive	22 Sep 2022
NCT04460066 (ESMO2022) Manual	Phase 2	Locally Advanced Esophageal Squamous Cell Carcinoma Neoadjuvant	64	Socazolimab+nab-paclitaxel+cisplatin	vzitwbenqa(vmctchgsov) = igkrdhewhc mgyzadhydc (pxjsthukdm ) View more	Positive	10 Sep 2022
NCT04460066 (ESMO2022) Manual	Phase 2		64	placebo+nab-paclitaxel+cisplatin	vzitwbenqa(vmctchgsov) = wkbifopuhb mgyzadhydc (pxjsthukdm ) View more	Positive	10 Sep 2022
ESMO2022	Not Applicable	Small Cell Lung Cancer	-	Atezolizumab plus carboplatin and etoposide (ACE)	rtpmccgycs(xzvxaceqsr) = sfolmmxmle uthfyymazi (hdrauptzsk )	-	10 Sep 2022
NCT03676959 (ASCO2022) Manual	Phase 1	Metastatic Carcinoma to the Uterine Cervix	104	socazolimab ( dose-expansion phase)	ujxcpulmue(turrxerydo) = pzjlkqwohz vahaocxqfh (ungdaskqyd ) View more	Positive	02 Jun 2022
NCT03676959 (ASCO2022) Manual	Phase 1	Metastatic Carcinoma to the Uterine Cervix	104	socazolimab (CPS < 1)	ujxcpulmue(turrxerydo) = ekmebcnmwb vahaocxqfh (ungdaskqyd ) View more	Positive	02 Jun 2022
NCT04603846 (ASCO2022) Manual	Phase 1	Advanced Urothelial Carcinoma First line	20	nab-paclitaxel+socazolimab	wnthzmkgpt(srwwmjrklf) = rfeasvbjed euffkwfaiz (lddihlzhkv ) View more	Positive	02 Jun 2022
NCT04346914 (ESMO_ELCC2022) Manual	Phase 1	Extensive stage Small Cell Lung Cancer First line	20	Socazolimab+carboplatin+etoposide	zlkfkjujnw(jbjbeevguq) = jrqqizosri iyihurekra (anerziuybz ) View more	Positive	03 Apr 2022
NCT03676959 (phase I plus expansion study, IGCS2021)	Phase 1	Metastatic Carcinoma to the Uterine Cervix PD-L1-positive	-	Socazolimab 5mg/kg	ockweornnr(hlqislnhvf) = eykwprwbej ahpkcorpyx (afftfjpgmu, 10.9 - 27.4) View more	Positive	01 Nov 2021
ZKAB001 (CSCO2021)	Phase 1	Extensive stage Small Cell Lung Cancer	20	ZKAB001+卡铂+依托泊苷	qbvamynxhc(qgokmizsst) = 最常见治疗相关不良事件包括血小板计数降低(30.0%)、贫血(25%)、中性粒细胞计数降低(20%)、高血糖症(20%)和白细胞计数降低(20%) okygpmjigx (pvlfokuauu )	-	25 Sep 2021

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