Gastric Cancer Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

March 03 10:14 2025
Gastric Cancer Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight’s, “Gastric Cancer Pipeline Insight” report provides comprehensive insights about 200+ companies and 220+ pipeline drugs in Gastric Cancer pipeline landscape. It covers the Gastric Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Gastric Cancer therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Explore our comprehensive Gastric Cancer Pipeline Report to stay informed about the latest advancements. Download copy now @ Gastric Cancer Pipeline Outlook

Key Takeaways from the Gastric Cancer Pipeline Report

  • In February 2025:- Bristol-Myers Squibb:- The purpose of this study is to determine the efficacy and safety of investigational drug relatlimab plus nivolumab in combination with chemotherapy in participants with unresectable, untreated, locally advanced or metastatic gastric or GEJ cancer.
  • In February 2025:- Jazz Pharmaceuticals:- This study is being done to find out if zanidatamab, when given with chemotherapy plus or minus tislelizumab, is safe and works better than trastuzumab given with chemotherapy. The patients in this study will have advanced human epidermal growth factor 2 (HER2)-positive stomach and esophageal cancers that are no longer treatable with surgery (unresectable) or chemoradiation, and/or have grown or spread to other parts of the body (metastatic).
  • In February 2025:- Bold Therapeutics, Inc.:- BOLD-100 is an intravenously administered sterile solution containing the ruthenium-based small molecule. BOLD-100 has been shown to preferentially decrease the expression of GRP78 in tumour cells and ER stressed cells when compared to normal cells. BOLD-100 will be combined with cytotoxic FOLFOX chemotherapy in this study, with a dose escalation cohort to ensure tolerability and safety, followed by a cohort expansion phase.
  • In February 2025:- AstraZeneca:- DESTINY-Gastric03 will investigate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of trastuzumab deruxtecan (T-DXd) alone or in combination with chemotherapy and/or immunotherapy in HER2-expressing advanced/metastatic gastric/gastroesophageal junction (GEJ) and esophageal adenocarcinoma patients.
  • DelveInsight’s Gastric Cancer pipeline report depicts a robust space with 200+ active players working to develop 220+ pipeline therapies for Gastric Cancer treatment.
  • The leading Gastric Cancer Companies such as BeiGene, Linton Pharm Co. Ltd., RAPT Therapeutics, Leap Therapeutics, Idience, Bolt Biotherapeutics, Hubro Therapeutics, Immunocore, Ambrx, Hangzhou DAC Biotech, Beijing Immunoah Pharma Tech, Base Therapeutics, Nanjing KAEDI Biotech, HiberCell, Transcenta Holding, Suzhou Zelgen Biopharmaceuticals, Daiichi Sankyo, Ipsen, Alligator Bioscience, Bristol Myers Squibb, Jiangsu Hengrui Medicine, Shanghai Junshi Biosciences, ImmunoACT and others.
  • Promising Gastric Cancer Therapies such as Avelumab, BBI608, Camrelizumab, Catumaxomab, RAPA-201, SHR-1210, Amivantamab, Atezolizumab, Bevacizumab, Cabozantinib, Cinrebafusp alfa, Crizotinib, DKN-01, DP303c, Eflornithine, EP0057, Epacadostat, FLX475, Futibatinib, GEN-001, HLX07, HLX22, Infigratinib, KH903, Lenvatinib, Masitinib, MAX-40279, MRG002, MRG003, Niraparib, Savolitinib, Minnelide, SHR-1701, Margetuximab, Bemarituzumab, Evorpacept, Lenvatinib, CDK-004, TPX-0022, TCRx_T Cells, IN10018, IMU-131, SOT102, CT041, AB011, Zanidatamab, NC410, PT 886, PRS-343, Oraxol, CA-4948, Q702, ACE1702, SI-B001, TT-4, LUM015, LB 1908, CUE-102, TORL-2-307-MAB, OBI-833/OBI-821, ASP2138, NC410, SO-C101, HC-5404-FU, CPL304110, LNS8801, RGX-202-01, A166, GZ17-6.02, HMPL-453, CCT303-406, VMD-928, ITI 4000, PAb 001, and others.

Discover how the Gastric Cancer treatment paradigm is evolving. Access DelveInsight’s in-depth Gastric Cancer Pipeline Analysis for a closer look at promising breakthroughs @ Gastric Cancer Clinical Trials and Studies

Gastric Cancer Emerging Drugs

  • Tislelizumab: BeiGene

Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. The China National Medical Products Administration (NMPA) has approved tislelizumab in six indications. Including full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy, for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and for second- or third-line treatment of patients with locally advanced or metastatic NSCLC who progressed on prior platinum-based chemotherapy. Tislelizumab is not approved for use outside of China. Currently the drug is registered for the treatment of gastric cancer.

  • Catumaxomab: Linton Pharm Co. Ltd.

Catumaxomab was approved by the European Medicines Agency in 2009 for the treatment of malignant ascites. It is a bispecific antibody that binds to EpCAM (the epithelial cell adhesion molecule) on the tumor cell–and CD3 on the T cell, recruits immune accessory cells through FcγR binding at the same time. Catumaxomab kills tumor cells by engaging T cell and accessory cell mediated cytotoxicity and has the potential to induce long-term vaccinal effects which has been verified in animal models. Currently, Catumaxomab is being evaluated in clinical trials for both advanced gastric cancer and non-muscle invasive bladder cancer. Currently the drug is in Phase III stage of development for the treatment of gastric cancer.

  • Tivumecirnon: RAPT Therapeutics

Tivumecirnon is a small molecule CCR4 antagonist designed to block the migration of regulatory T cells (Treg) specifically into tumors, but not healthy tissues. Treg represent a dominant pathway for downregulating the immune response, generally correlate with poor clinical outcomes and may limit the effectiveness of currently available therapies such as checkpoint inhibitors. Tivumecirnon may restore naturally occurring antitumor immunity alone and may synergize with a variety of both conventional and immune-based therapies, such as radiation, chemotherapy, checkpoint inhibitors, immune stimulators, cancer vaccines and adoptive T cell therapy. Currently the drug is in Phase II stage of development for the treatment of gastric cancer.

  • DKN-01: Leap Therapeutics

DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein, a modulator of Wnt/Beta-catenin signaling, a signaling pathway frequently implicated in tumorigenesis and suppressing the immune system. DKK1 has an important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment through enhancing the activity of myeloidderived suppressor cells and downregulating NK ligands on tumor cells. DKN-01 has received Orphan Drug Designation for the treatment of gastric and gastroesophageal junction cancer from the U.S. Food and Drug Administration. Currently the drug is in Phase II stage of development for the treatment of gastric cancer.

  • Venadaparib: Idience

Venadaparib (IDX-1197) is a potent PARP inhibitor that prevents the repair of DNA single-strand breaks (SSB) and promote the conversion of SSB to double-stranded breaks (DSB), which ultimately leads to synthetic lethality in cancer cells. IDX-1197 is under clinical development targeting multiple solid tumors as a monotherapy (including maintenance) and for combination with other anti-cancer agents. Currently the drug is in Phase I stage of development for the treatment of gastric cancer.

  • BDC-4182: Bolt Biotherapeutics

BDC-4182 is Bolt’s next-generation ISAC candidate targeting Claudin 18.2, a novel target in oncology, with programs in development for the treatment of gastric or gastroesophageal junction cancer and pancreatic cancer. Currently the drug is in Preclinical stage of development for the treatment of gastric cancer.

The Gastric Cancer pipeline report provides insights into

  • The report provides detailed insights about companies that are developing therapies for the treatment of Gastric Cancer with aggregate therapies developed by each company for the same.
  • It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Gastric Cancer Treatment.
  • Gastric Cancer Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
  • Gastric Cancer Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
  • Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Gastric Cancer market.

Get a detailed analysis of the latest innovations in the Gastric Cancer pipeline. Explore DelveInsight’s expert-driven report today! @ Gastric Cancer Unmet Needs

Gastric Cancer Companies

BeiGene, Linton Pharm Co. Ltd., RAPT Therapeutics, Leap Therapeutics, Idience, Bolt Biotherapeutics, Hubro Therapeutics, Immunocore, Ambrx, Hangzhou DAC Biotech, Beijing Immunoah Pharma Tech, Base Therapeutics, Nanjing KAEDI Biotech, HiberCell, Transcenta Holding, Suzhou Zelgen Biopharmaceuticals, Daiichi Sankyo, Ipsen, Alligator Bioscience, Bristol Myers Squibb, Jiangsu Hengrui Medicine, Shanghai Junshi Biosciences, ImmunoACT and others.

Gastric Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

  • Intravenous
  • Subcutaneous
  • Oral
  • Intramuscular

Gastric Cancer Products have been categorized under various Molecule types such as

  • Monoclonal antibody
  • Small molecule
  • Peptide

Download DelveInsight’s latest report to gain strategic insights into upcoming Gastric Cancer Therapies and key Gastric Cancer Developments @ Gastric Cancer Market Drivers and Barriers, and Future Perspectives

Scope of the Gastric Cancer Market Report

  • Coverage- Global
  • Gastric Cancer Companies- BeiGene, Linton Pharm Co. Ltd., RAPT Therapeutics, Leap Therapeutics, Idience, Bolt Biotherapeutics, Hubro Therapeutics, Immunocore, Ambrx, Hangzhou DAC Biotech, Beijing Immunoah Pharma Tech, Base Therapeutics, Nanjing KAEDI Biotech, HiberCell, Transcenta Holding, Suzhou Zelgen Biopharmaceuticals, Daiichi Sankyo, Ipsen, Alligator Bioscience, Bristol Myers Squibb, Jiangsu Hengrui Medicine, Shanghai Junshi Biosciences, ImmunoACT and others.
  • Gastric Cancer Therapies- Avelumab, BBI608, Camrelizumab, Catumaxomab, RAPA-201, SHR-1210, Amivantamab, Atezolizumab, Bevacizumab, Cabozantinib, Cinrebafusp alfa, Crizotinib, DKN-01, DP303c, Eflornithine, EP0057, Epacadostat, FLX475, Futibatinib, GEN-001, HLX07, HLX22, Infigratinib, KH903, Lenvatinib, Masitinib, MAX-40279, MRG002, MRG003, Niraparib, Savolitinib, Minnelide, SHR-1701, Margetuximab, Bemarituzumab, Evorpacept, Lenvatinib, CDK-004, TPX-0022, TCRx_T Cells, IN10018, IMU-131, SOT102, CT041, AB011, Zanidatamab, NC410, PT 886, PRS-343, Oraxol, CA-4948, Q702, ACE1702, SI-B001, TT-4, LUM015, LB 1908, CUE-102, TORL-2-307-MAB, OBI-833/OBI-821, ASP2138, NC410, SO-C101, HC-5404-FU, CPL304110, LNS8801, RGX-202-01, A166, GZ17-6.02, HMPL-453, CCT303-406, VMD-928, ITI 4000, PAb 001, and others.
  • Gastric Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
  • Gastric Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Which companies are leading the race in Gastric Cancer drug development? Find out in DelveInsight’s exclusive Gastric Cancer Pipeline Report—access it now! @ Gastric Cancer Emerging Drugs and Major Companies

Table of Content

  1. Introduction
  2. Executive Summary
  3. Gastric Cancer: Overview
  4. Pipeline Therapeutics
  5. Therapeutic Assessment
  6. Gastric Cancer– DelveInsight’s Analytical Perspective
  7. Late Stage Products (Phase III)
  8. Catumaxomab: Linton Pharm Co. Ltd.
  9. Drug profiles in the detailed report…..
  10. Mid Stage Products (Phase II)
  11. Tivumecirnon: RAPT Therapeutics
  12. Drug profiles in the detailed report…..
  13. Early Stage Products (Phase I)
  14. Venadaparib: Idience
  15. Drug profiles in the detailed report…..
  16. Preclinical and Discovery Stage Products
  17. BDC-4182: Bolt Biotherapeutics
  18. Drug profiles in the detailed report…..
  19. Inactive Products
  20. Gastric Cancer Key Companies
  21. Gastric Cancer Key Products
  22. Gastric Cancer- Unmet Needs
  23. Gastric Cancer- Market Drivers and Barriers
  24. Gastric Cancer- Future Perspectives and Conclusion
  25. Gastric Cancer Analyst Views
  26. Gastric Cancer Key Companies
  27. Appendix

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