Clinical Trials for Esophageal 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, Multi-Center Study to Evaluate the Efficacy and Safety of Volrustomig as Monotherapy or in Combination With Anti-cancer Agents in Participants With Advanced/Metastatic 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 recurrent or metastatic cervical cancer after 1–2 prior systemic regimens, or incurable recurrent or metastatic head and neck squamous cell carcinoma, receive volrustomig alone or, in one head and neck cohort, with platinum-based chemotherapy. Volrustomig is an investigational bispecific antibody targeting PD-1 and CTLA-4.

ClinicalTrials.gov ID: NCT06535607

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

HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects With Locally Advanced or Metastatic 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

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with ECOG 0–1 and previously treated, refractory, locally advanced unresectable or metastatic solid tumors across multiple tumor-specific cohorts receive patritumab deruxtecan 5.6 mg/kg IV every 3 weeks. This investigational HER3-targeted antibody–drug conjugate delivers an exatecan-derived topoisomerase I inhibitor payload.

ClinicalTrials.gov ID: NCT06172478

A Phase II Study of agenT-797 (Invariant Natural Killer T Cells), Botensilimab, a Novel Fc-enhanced CTLA-4 Inhibitor, Plus Balstilimab (Anti-PD-1) With Ramucirumab and Paclitaxel for Patients With Previously Treated, Advanced Esophageal, Gastric, or Gastro-esophageal 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

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with unresectable or metastatic esophageal, gastric, or gastroesophageal junction adenocarcinoma after one prior metastatic treatment line, or recurrence during or within six months of perioperative therapy, receive ramucirumab plus paclitaxel with investigational agenT-797 (CD1d-directed invariant natural killer T cells), botensilimab (Fc-enhanced anti-CTLA-4), and balstilimab (anti-PD-1).

ClinicalTrials.gov ID: NCT06251973

A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)

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

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with unresectable locally advanced or metastatic ESCC who have progressed after platinum-based chemotherapy and an immune checkpoint inhibitor are randomized to ifinatamab deruxtecan or investigator’s choice of docetaxel, paclitaxel, or irinotecan. Ifinatamab deruxtecan is an investigational B7-H3–targeting antibody–drug conjugate that delivers a topoisomerase I inhibitor.

ClinicalTrials.gov ID: NCT06644781