Clinical Trials for Esophageal Cancer

A Phase 1B, Multicenter, Open-Label Study of the Safety and Efficacy of CHS-114 in Combination With Toripalimab With or Without Other Treatments in Participants With Advanced or Metastatic Solid Tumors

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, advanced/metastatic gastric/GEJ/esophageal adenocarcinoma (HER2‑negative, MSS/pMMR) in the 2L setting and ESCC in 1L or 2L receive the anti‑CCR8 monoclonal antibody CHS‑114 (depletes intratumoral CCR8+ Tregs via enhanced ADCC/ADCP) plus the PD‑1 inhibitor toripalimab, with cisplatin/5‑FU added in 1L ESCC. Requires measurable disease and tissue; excludes active CNS metastases and prior anti‑CCR8.

ClinicalTrials.gov ID: NCT06657144

Phase I Trial of CA-4948 in Combination With FOLFOX/PD-1 Inhibitor +/- Trastuzumab for Untreated Unresectable Gastric and Esophageal Cancer

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: First-line treatment for adults with unresectable/metastatic gastric, GEJ, or esophageal adenocarcinoma or squamous cell carcinoma (ECOG 0–1), testing oral IRAK4 inhibitor emavusertib (CA‑4948; targets TLR/IL‑1R→NF‑κB signaling, with FLT3/CLK activity) added to mFOLFOX7 plus PD‑1 blockade. HER2‑negative patients receive emavusertib + mFOLFOX7 + nivolumab; HER2‑positive patients receive emavusertib + mFOLFOX7 + pembrolizumab + trastuzumab.

ClinicalTrials.gov ID: NCT05187182

A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer Previously Exposed to PD-1/PD-L1 Treatment (KEYMAKER-U06): Substudy 06B

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 metastatic or unresectable esophageal squamous cell carcinoma who progressed after one prior platinum regimen that included PD‑1/PD‑L1 therapy; compares standard second-line paclitaxel or irinotecan versus investigational sacituzumab tirumotecan (TROP2-directed topoisomerase I ADC), with previously planned pembrolizumab/MK‑4830 combinations closed to enrollment. Primary focus is safety and objective response with blinded central review, with secondary endpoints including PFS and OS.

ClinicalTrials.gov ID: NCT05319730

A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy in Participants With 1L Locally Advanced Unresectable/Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06E

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: Enrolling adults with previously untreated locally advanced unresectable or metastatic esophageal squamous cell carcinoma (ECOG 0–1) and measurable disease. Patients receive pembrolizumab plus mFOLFOX6 (control) or pembrolizumab combined with an antibody–drug conjugate: ifinatamab deruxtecan (B7-H3/CD276–targeted ADC delivering a cleavable topoisomerase I inhibitor payload [DXd]) with or without fluoropyrimidine/leucovorin ± oxaliplatin, or sacituzumab tirumotecan (TROP2-directed ADC with a topoisomerase I inhibitor payload) plus fluoropyrimidine/leucovorin.

ClinicalTrials.gov ID: NCT06780111

A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE892 as Monotherapy and Combination Therapy in Participants With MTAP-Deleted Advanced Solid Tumors

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 centrally confirmed MTAP homozygous loss/deletion and advanced solid tumors (ECOG 0–1) who have progressed after standard therapy are enrolled in dose escalation (mesothelioma, gastroesophageal, NSCLC, urothelial), with dose-expansion limited to MTAP-deleted NSCLC after platinum chemotherapy and PD-1/PD-L1 therapy (≤3 prior lines, prior appropriate targeted therapy if actionable). Participants receive IDE892, an MTA-cooperative PRMT5 inhibitor, as monotherapy or combined with IDE397, an oral MAT2A inhibitor, in 21-day cycles.

ClinicalTrials.gov ID: NCT07277413

A Phase 1b/2 Open-label Study to Assess the Safety and Efficacy of ASP546C in Participants With CLDN18.2-expressing Locally Advanced Unresectable or Metastatic Gastroesophageal Adenocarcinoma, Pancreatic Adenocarcinoma or Other Solid Tumor Types

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: Open-label multicohort study for patients with CLDN18.2-expressing unresectable locally advanced or metastatic gastroesophageal adenocarcinoma, pancreatic adenocarcinoma, or selected other solid tumors after at least one prior systemic therapy and ECOG 0–1. Participants receive IV ASP546C every 3 weeks, a CLDN18.2-targeted antibody–drug conjugate delivering a topoisomerase I inhibitor payload, with dose evaluation in gastroesophageal cancer and higher-dose cohorts in pancreatic and pan-tumor populations.

ClinicalTrials.gov ID: NCT07488676

A Phase 1 Study to Evaluate the Safety and Efficacy of DISP-10 in Participants With Advanced Gastrointestinal Cancers

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 advanced/metastatic esophageal, gastroesophageal junction, gastric, or colorectal adenocarcinoma with measurable disease and ECOG 0–1 receive DISP-10, combining DV-10 adenoviral therapy with BCMA-directed autologous CAR T-cell therapy idecabtagene vicleucel after fludarabine/cyclophosphamide lymphodepletion. The study includes dose escalation and expansion to assess safety and preliminary antitumor activity in GI solid tumors.

ClinicalTrials.gov ID: NCT07544589

A Phase 1/2, Open-label, Dose-escalation, and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Therapeutic Activity of GI-101 As a Single Agent and in Combination with Pembrolizumab, Lenvatinib or Local Radiotherapy in Patients with Advanced or Metastatic Solid Tumors (Keynote B59)

Active drug

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

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

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: This trial involves adult patients with advanced or metastatic solid tumors and evaluates the safety and therapeutic activity of GI-101, a bispecific fusion protein targeting CTLA-4 and the IL-2 pathway, as a single agent and in combination with pembrolizumab, lenvatinib, or radiotherapy.

ClinicalTrials.gov ID: NCT04977453

A Phase 1/2, First-in-Human, Open Label, Dose Escalation and Expansion Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer

Active drug

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

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

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: Adult patients with unresectable locally advanced or metastatic solid tumors (including melanoma, renal cell carcinoma, or PD-L1-positive NSCLC) who have progressed after or are ineligible for standard therapies receive AU-007, a novel monoclonal antibody that redirects IL-2 activity toward effector T and NK cells by blocking IL-2Rα, as monotherapy or in combination with recombinant IL-2 and/or checkpoint inhibitors. Patients must have adequate organ function, resolved prior immunotherapy toxicity, and measurable or evaluable disease.

ClinicalTrials.gov ID: NCT05267626

A Phase 1 Study of SGN-B6A in Advanced Solid Tumors

Active drug

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

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

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: This trial enrolls adults with metastatic or unresectable solid tumors (including NSCLC, HNSCC, HER2-negative breast, esophageal, cutaneous SCC, ovarian, bladder, cervical, pancreatic, and gastric cancers), evaluating the antibody-drug conjugate sigvotatug vedotin—targeting integrin beta-6—with or without pembrolizumab and/or platinum chemotherapy. Eligibility varies by cohort, including both treatment-naïve and previously treated/refractory patients, with fresh or recent tumor biopsy required in some arms.

ClinicalTrials.gov ID: NCT04389632