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: This trial enrolls adults with metastatic or unresectable solid tumors (excluding NSCLC) harboring activating HER2 mutations, who have progressed on standard therapy or have no satisfactory alternatives. Patients receive BAY2927088, an oral reversible tyrosine kinase inhibitor targeting mutant HER2 and EGFR.

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 advanced/metastatic solid tumors in three cohorts: recurrent/metastatic cervical cancer after 1–2 prior lines; recurrent/metastatic HNSCC (including PD-L1–positive, systemic-therapy–naive or platinum-refractory); and untreated R/M HNSCC receive volrustomig, a bispecific PD-1/CTLA-4 antibody, as monotherapy or combined with chemo (carboplatin/paclitaxel or 5-FU plus platinum). Excludes prior checkpoint inhibitor exposure and requires ECOG 0–1 and PD-L1 testing; endpoints include ORR and safety per RECIST 1.1.

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 locally advanced or metastatic CLDN18.2-positive, HER2-negative gastric/GEJ/distal esophageal adenocarcinoma (ECOG 0–1) are enrolled in PD-L1/ICI-eligibility–defined cohorts. Cohort 1 (PD-L1+ and ICI-eligible) tests the CLDN18.2-targeted ADC sonesitatug vedotin (CLDN18.2-directed, MMAE payload) plus capecitabine with rilvegostomig (PD-1/TIGIT bispecific) or with nivolumab versus standard nivolumab + CAPOX/FOLFOX, while Cohort 2 (PD-L1− or ICI-ineligible) compares sonesitatug vedotin + capecitabine versus zolbetuximab + CAPOX/FOLFOX.

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 gastric, gastroesophageal junction, or esophageal adenocarcinoma that is CLDN18.2-positive and PD-L1 CPS ≥1 (ECOG 0–1; measurable disease; prior perioperative therapy allowed if completed ≥6 months prior) are randomized to add givastomig (TJ033721), a CLDN18.2×4-1BB/CD137 bispecific antibody providing tumor-localized T-cell costimulation, to nivolumab plus mFOLFOX or CAPOX versus nivolumab plus the same chemotherapy alone. Two IV givastomig dose levels are tested alongside standard nivolumab/oxaliplatin-fluoropyrimidine chemotherapy.

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: Adults with previously untreated, measurable advanced/metastatic gastric, gastroesophageal junction, or distal esophageal adenocarcinoma that is HER2-negative and PD-L1 ≥1 are randomized to platinum/fluoropyrimidine chemotherapy (FOLFOX or CAPOX) plus pumitamig (BNT327/PM8002; bispecific anti–PD-L1/anti–VEGF-A checkpoint/anti-angiogenic antibody) versus the standard nivolumab (anti–PD-1) plus the same chemotherapy backbone. Key exclusions include untreated CNS metastases, recent major cardiovascular/thromboembolic events or uncontrolled hypertension, major coagulation disorders, recent GI perforation/fistula, and recent major surgery/trauma.

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 previously untreated locally advanced unresectable or metastatic HER2-negative adenocarcinoma of the esophagus, GEJ, or stomach receive first-line ivonescimab plus FOLFOX. Ivonescimab is an investigational tetravalent bispecific antibody that blocks both PD-1 and VEGF, combining checkpoint inhibition with anti-angiogenic activity.

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: Enrolls treatment-naïve adults with locally advanced or metastatic HER2-negative, PD-L1–positive gastric, gastroesophageal junction, or esophageal adenocarcinoma and ECOG 0–1. Patients receive PF-08634404/SSGJ-707, an investigational bispecific antibody targeting PD-1 and VEGF, plus chemotherapy, with phase 3 comparison against nivolumab plus chemotherapy.

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 measurable, unresectable locally advanced or metastatic solid tumors that have progressed after standard therapies, enrolled in tumor-specific refractory cohorts (e.g., melanoma post–PD-(L)1, SCCHN post platinum/PD-(L)1, HER2-negative gastric/GEJ, HGS ovarian, cervical, endometrial, urothelial, ESCC, pancreatic, mCRPC, nonsquamous NSCLC without drivers, and HR+/HER2– breast cancer after CDK4/6 and chemo). Single-arm therapy is patritumab deruxtecan (HER3-DXd) 5.6 mg/kg IV q3w, an HER3-targeted antibody–drug conjugate delivering a topoisomerase I inhibitor (DXd).

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/metastatic esophageal, gastric, or GEJ adenocarcinoma after one prior line (or relapse ≤6 months after perioperative therapy), ECOG 0–1, receive ramucirumab plus paclitaxel combined with investigational immunotherapies: agenT‑797 (allogeneic invariant NKT cell therapy targeting CD1d-presented glycolipids), botensilimab (Fc‑enhanced CTLA‑4 inhibitor), and balstilimab (PD‑1 inhibitor). Excludes prior ramucirumab, recent taxane, severe prior irAEs from PD‑(L)1/CTLA‑4, active CNS mets, significant neuropathy, or active viral infections.

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 or metastatic ESCC after exactly one prior platinum-based chemo plus immune checkpoint inhibitor are randomized to ifinatamab deruxtecan, a B7-H3–targeted antibody–drug conjugate delivering a topoisomerase I inhibitor, versus investigator’s choice of docetaxel, paclitaxel, or irinotecan. Key eligibility includes ECOG 0–1, measurable disease, and exclusion of prior B7‑H3 or topo I agents and significant ILD/pneumonitis or CNS disease.

ClinicalTrials.gov ID: NCT06644781