Clinical Trials for Esophageal Cancer

A Phase I/II Trial of Cabozantinib in Combination with Durvalumab (MEDI4736) with or Without Tremelimumab in Patients with Advanced Gastroesophageal Cancer and Other Gastrointestinal (GI) Malignancies (CAMILLA)

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.

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.

HealthScout AI summary: Adults with ECOG 0–1 and advanced/unresectable gastric/GEJ or esophageal adenocarcinoma (post ≥1 line), colorectal adenocarcinoma (post ≥2 lines; anti-EGFR if RAS WT), or hepatocellular carcinoma (treatment‑naive or previously treated) receive cabozantinib (MET/VEGFR2/AXL multikinase inhibitor) plus durvalumab (PD‑L1 inhibitor), with an HCC cohort also getting a single priming dose of tremelimumab (CTLA‑4 antibody). Baseline/on‑treatment biopsies required; prior PD‑1/PD‑L1 generally excluded except per HCC and gastric/esophageal protocol allowances.

ClinicalTrials.gov ID: NCT03539822

A Phase 1/2, Open-label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD70 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX131) in Adult Subjects With Relapsed or Refractory Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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.

HealthScout AI summary: Adults with unresectable/metastatic relapsed or refractory clear cell RCC, cervical, pancreatic, esophageal cancers, or malignant pleural mesothelioma receive a single infusion of CTX131, an allogeneic CRISPR–Cas9–engineered CD70‑directed CAR T cell (TRAC knock-in; B2M, CD70, Regnase‑1, TGFBR2 knockouts) after lymphodepleting chemotherapy. Designed to enhance expansion/persistence and resist TGF‑β–mediated suppression; excludes prior anti‑CD70 therapy and significant CNS/cardiac/pulmonary disease or active infections.

ClinicalTrials.gov ID: NCT05795595

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Advanced or Metastatic Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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.

HealthScout AI summary: Adults with unresectable locally advanced or metastatic CLDN18.2-positive solid tumors (e.g., gastric/GEJ, pancreatic, esophageal adenocarcinoma, biliary tract cancers) after prior systemic therapy receive BL-M05D1, an IV CLDN18.2-targeting antibody–drug conjugate linking a cathepsin B–cleavable topoisomerase I inhibitor payload, given every 21 days. Key eligibility includes measurable disease, ECOG 0–1, adequate organ function, and prior appropriate targeted/immunotherapy for actionable biomarkers.

ClinicalTrials.gov ID: NCT07021066

A Phase 1, Open-Label, Dose Escalation and Expansion, Multicenter Study of Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells in Subjects With Unresectable, Locally Advanced, or Metastatic Gastric, Gastroesophageal Junction (GEJ), Esophageal, or Pancreatic Adenocarcinoma

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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.

HealthScout AI summary: Adults with unresectable, locally advanced, or metastatic gastric/GEJ/esophageal or pancreatic adenocarcinoma expressing CLDN18.2 (IHC ≥1+ in ≥50%) receive LB1908, an autologous CLDN18.2-directed CAR-T therapy, as monotherapy in second or later lines or as consolidation after disease control on first-line chemotherapy. Key exclusions include prior cellular/gene therapy, significant effusions/bleeding risk, active autoimmune disease requiring immunosuppression, unstable cardiac/infectious disease, and active CNS disease (except stable treated brain mets in monotherapy cohorts).

ClinicalTrials.gov ID: NCT05539430

A Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD5863, a T Cell-engaging Bispecific Antibody That Targets Claudin 18.2 (CLDN18.2) and CD3 in Adult Participants With Advanced or Metastatic Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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.

HealthScout AI summary: Adults with CLDN18.2-positive advanced/metastatic gastric, GEJ, esophageal, or pancreatic adenocarcinoma after prior systemic therapy receive AZD5863 monotherapy, a CLDN18.2×CD3 T cell–engaging bispecific antibody, via IV or SC administration. Trial focuses on dose finding and preliminary efficacy with RECIST-measurable disease and ECOG 0–1 required.

ClinicalTrials.gov ID: NCT06005493

A Phase I Dose-Escalation Trial of vvDD-hIL2-2-RG-1 (Vaccina Virus Double Deleted) Administered by Intra-tumoral (IT) Injection for Metastatic Gastrointestinal and Peritoneal Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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.

HealthScout AI summary: Adults <70 with metastatic gastrointestinal or peritoneal tumors (esophageal, gastric, colorectal, liver, pancreatic) refractory to standard therapy, with at least one lesion amenable to intratumoral injection. Single intratumoral dose of vvDD-hIL2-2-RG-1, an oncolytic vaccinia virus (double-deleted TK/VGF) engineered to express membrane-tethered IL-2 to promote localized T-cell activation and oncolysis; no combination therapy in this first-in-human, single-dose escalation.

ClinicalTrials.gov ID: NCT07001592

A Phase II Study of sFOLFOXIRI in Advanced Gastroesophageal Cancer (SAGE)

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.

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.

HealthScout AI summary: Adults with metastatic or unresectable HER2‑negative adenocarcinoma of the esophagus/GEJ/stomach (no prior metastatic therapy; ECOG 0–2) receive an alternating doublet sFOLFOXIRI schedule: mFOLFOX6 on odd cycles and FOLFIRI on even cycles every 2 weeks. Optional nivolumab (PD‑1 inhibitor) may be added per label to enhance antitumor activity.

ClinicalTrials.gov ID: NCT05332002

A Phase 1, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Activity of VVD-130037, a Kelch-like ECH Associated Protein 1 (KEAP1) Activator, in Participants With Advanced Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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.

HealthScout AI summary: Adults with metastatic/unresectable solid tumors after standard therapy, with dose expansion in squamous histologies (sqNSCLC with/without NRF2 or CUL3 mutations, HNSCC, ESCC post–platinum and checkpoint inhibitor), receive the investigational KEAP1 activator VVD-130037 orally as monotherapy or combined with docetaxel or paclitaxel. VVD-130037 is a covalent, allosteric molecular glue that enhances KEAP1–CUL3–mediated NRF2 degradation to counter NRF2-driven oncogenesis and taxane resistance; patients with KEAP1 nonsense/frameshift mutations are excluded.

ClinicalTrials.gov ID: NCT05954312

An Open-Label, Multiple-Dose, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VMD-928 in Subjects With Solid Tumors or Lymphoma

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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.

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.

HealthScout AI summary: This trial enrolls adults with advanced solid tumors or lymphoma that are refractory to standard therapies, whose tumors overexpress TrkA or harbor an NTRK1 gene fusion, to receive oral VMD-928, a highly selective irreversible TrkA inhibitor that acts via allosteric dimerization and inactivation of the target. Key exclusions include significant comorbidities and impaired drug absorption.

ClinicalTrials.gov ID: NCT03556228

A Phase 1, Open-Label, Multicenter Study of INCB123667 as Monotherapy and in Combination With Anticancer Therapies in Participants With Selected Advanced Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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.

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.

HealthScout AI summary: This study enrolls adults with advanced or metastatic solid tumors (including selected breast, gynecologic, and gastrointestinal cancers) who have progressed on or are ineligible for standard therapies, investigating INCB123667 (mechanism unknown) as monotherapy or in combination with agents such as palbociclib, ribociclib, fulvestrant, bevacizumab, olaparib, or paclitaxel. Patients must have good performance status (ECOG 0-1), and the trial includes tumor-specific expansion cohorts.

ClinicalTrials.gov ID: NCT05238922