Clinical Trials for Stomach Cancer

A Phase 2 Open-label Basket Study to Evaluate the Efficacy and Safety of Orally Administered Reversible Tyrosine Kinase Inhibitor BAY 2927088 in Participants With Metastatic or Unresectable Solid Tumors With HER2-activating Mutations

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with unresectable or metastatic solid tumors other than NSCLC that harbor an activating HER2 mutation are eligible after appropriate standard therapy or when no satisfactory alternative exists; prior HER2 tyrosine kinase inhibitor treatment and active brain metastases are excluded. All participants receive oral sevabertinib, a reversible HER2-directed tyrosine kinase inhibitor, 20 mg twice daily.

ClinicalTrials.gov ID: NCT06760819

A Phase II Multicenter Trial of ESK981 in Patients With Select Solid Tumors

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with advanced pancreatic adenocarcinoma or adenosquamous carcinoma, pancreatic or gastrointestinal neuroendocrine neoplasms (Ki-67 >20%), or metastatic prostate cancer with neuroendocrine features after progression on or intolerance of standard therapy receive oral ESK981 in separate single-arm cohorts. ESK981 is an investigational kinase inhibitor targeting VEGFR-1, VEGFR-2, and Tie-2, with preclinical evidence of PIKfyve inhibition.

ClinicalTrials.gov ID: NCT05988918

A Randomized, Double-blinded, Multicenter, Phase Ⅲ Clinical Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab and Chemotherapy (XELOX) Versus Trastuzumab and Chemotherapy (XELOX) With or Without Pembrolizumab for the First Line Treatment of Locally Advanced or Metastatic Gastroesophageal Junction and Gastric Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with previously untreated, unresectable locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma and ECOG 0–1 receive first-line trastuzumab plus XELOX, with or without pembrolizumab. The trial tests adding HLX22, an investigational anti-HER2 antibody that binds a site distinct from trastuzumab’s, versus placebo.

ClinicalTrials.gov ID: NCT06532006

A Phase II Trial of Avutometinib in Combination With Defactinib in Metastatic Diffuse Gastric Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with previously treated unresectable or metastatic diffuse-type, poorly cohesive, signet ring cell, or mixed gastric or gastroesophageal junction cancer are eligible; patients with pathogenic CDH1 or RHOA mutations are eligible regardless of histology. All participants receive oral avutometinib, a RAF–MEK pathway inhibitor, plus defactinib, a focal adhesion kinase inhibitor.

ClinicalTrials.gov ID: NCT06487221

A Phase III Multi-center, Open-label, Sponsor-blinded, Randomized Study of AZD0901 Monotherapy Compared With Investigator's Choice of Therapy in Second- or Later-Line Adult Participants With Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2 (CLARITY Gastric 01)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with CLDN18.2-positive, HER2-negative unresectable or metastatic gastric, gastroesophageal junction, or distal esophageal adenocarcinoma that has progressed after fluoropyrimidine- and platinum-containing therapy are randomized to intravenous AZD0901 or investigator’s choice of therapy. AZD0901 is an investigational CLDN18.2-targeted antibody–drug conjugate that delivers the microtubule-disrupting payload MMAE.

ClinicalTrials.gov ID: NCT06346392

A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in First-Line Claudin18.2-Positive, HER2-Negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with previously untreated, unresectable or metastatic CLDN18.2-positive, HER2-negative gastric, gastroesophageal junction, or distal esophageal adenocarcinoma receive first-line treatment according to PD-L1 status and checkpoint-inhibitor eligibility. The study compares capecitabine plus sonesitatug vedotin, a CLDN18.2-directed antibody–drug conjugate, with or without rilvegostomig, a PD-1/TIGIT-blocking antibody, against nivolumab-based chemotherapy or zolbetuximab-based or oxaliplatin-based chemotherapy.

ClinicalTrials.gov ID: NCT07431281

A Randomized, Multicenter, Open-Label, Phase 2 Study of Givastomig (TJ033721) in Combination With Nivolumab and Chemotherapy Versus Nivolumab and Chemotherapy in Participants With Previously Untreated CLDN18.2 Positive and PD-1L Positive Locally Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Junction Adenocarcinoma

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with previously untreated, unresectable locally advanced or metastatic HER2-negative, CLDN18.2-positive, PD-L1-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma receive nivolumab plus mFOLFOX or CAPOX, with or without givastomig. Givastomig is an investigational bispecific antibody targeting CLDN18.2 and the T-cell costimulatory receptor 4-1BB.

ClinicalTrials.gov ID: NCT07432295

ROSETTA Gastric-204: A Blinded, Randomized, Phase 2/3 Study of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: For adults with previously untreated, HER2-negative, PD-L1–positive (≥1) advanced or metastatic gastric, gastroesophageal junction, or distal esophageal adenocarcinoma, this trial compares pumitamig plus platinum-fluoropyrimidine chemotherapy with nivolumab plus the same chemotherapy. Pumitamig is an investigational bispecific antibody targeting PD-L1 and VEGF-A.

ClinicalTrials.gov ID: NCT07221149

A Single-Arm, Phase II Study of Ivonescimab in Combination With FOLFOX in Advanced HER2 Negative Gastroesophageal Adenocarcinomas

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with unresectable locally advanced or metastatic HER2-negative esophageal, gastroesophageal junction, or gastric adenocarcinoma who have not received treatment for advanced disease receive first-line ivonescimab plus FOLFOX. Ivonescimab is a bispecific antibody targeting PD-1 and VEGF-A; it is given alone for the first treatment, with FOLFOX added from cycle 2 onward.

ClinicalTrials.gov ID: NCT07070466

A PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC GASTRIC, GASTROESOPHAGEAL JUNCTION, OR ESOPHAGEAL ADENOCARCINOMA

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: For treatment-naïve adults with locally advanced or metastatic HER2-negative, PD-L1-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma and ECOG performance status 0–1, this study evaluates PF-08634404 plus chemotherapy against nivolumab plus chemotherapy. PF-08634404 is an investigational bispecific antibody targeting PD-1 and VEGF.

ClinicalTrials.gov ID: NCT07392892