Clinical Trials for Esophageal Cancer

A Multi-Center Phase I Trial of Neratinib and Fam-trastuzumab Deruxtecan in Advanced Refractory Gastric and Esophageal Cancer Patients

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.

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.

TrialFetch AI summary: Enrolling adults with metastatic/unresectable HER2-positive GI cancers—primarily gastroesophageal/GEJ adenocarcinoma after prior chemo plus HER2 therapy (other HER2 IHC 3+ GI tumors allowed)—with ECOG 0–2 and no prior TDxD. Patients receive daily oral neratinib (irreversible pan-HER TKI: EGFR/HER1, HER2, HER4) with q21-day IV fam-trastuzumab deruxtecan (HER2-directed ADC with topoisomerase I payload) to define safety/MTD, with attention to diarrhea and ILD risks.

ClinicalTrials.gov ID: NCT05274048

Randomized Phase III Trial of mFOLFIRINOX vs. FOLFOX With Nivolumab for First-Line Treatment of Metastatic HER2- Gastroesophageal Adenocarcinoma

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.

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.

TrialFetch AI summary: Adults with unresectable/metastatic HER2‑negative adenocarcinoma of the esophagus/GEJ/stomach (ECOG 0–1; prior periop/adjuvant therapy allowed if >1 year) are randomized to first-line mFOLFIRINOX versus mFOLFOX, each given with or without nivolumab. Nivolumab is a PD-1 inhibitor restoring antitumor T‑cell activity; the trial tests whether adding irinotecan (FOLFIRINOX) improves outcomes over FOLFOX, with key exclusions including significant neuropathy, active autoimmune disease, and UGT1A1*28 homozygosity/Gilbert’s.

ClinicalTrials.gov ID: NCT05677490

Phase II Prospective, Open Label Randomized Controlled Trial Comparing Standard of Care Therapy With and Without Sequential Cytoreductive Intervention for Patients With Metastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels

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: Randomizes adults with ctDNA-negative, oligometastatic stage IV foregut adenocarcinoma after ≥4 months of non-progressing systemic therapy to definitive local cytoreduction of all known primary/metastatic sites versus continued standard systemic therapy. Local treatment may include surgery, radiation, ablation, or embolization, with serial tumor-informed Signatera ctDNA monitoring in both arms.

ClinicalTrials.gov ID: NCT07282912

An Open-Label, Single-Arm, Phase 2 Study to Evaluate the Efficacy and Safety of Tislelizumab Plus Chemotherapy in a First-Line Setting for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma in US Racial and Ethnic Minority Patients

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 from US racial or ethnic minority populations with previously untreated PD-L1-positive, locally advanced unresectable or metastatic HER2-negative gastric/gastroesophageal adenocarcinoma or esophageal squamous cell carcinoma receive tislelizumab, an anti–PD-1 antibody, plus first-line platinum/fluoropyrimidine chemotherapy (FOLFOX, CAPOX, or cisplatin/5-FU depending on tumor type).

ClinicalTrials.gov ID: NCT07554521

A Phase 1a/1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Advanced or Metastatic Urothelial Carcinoma or Other 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.

TrialFetch AI summary: This trial involves patients with advanced or metastatic solid tumors expressing Nectin-4, including urothelial carcinoma, triple-negative breast cancer, non-small cell lung cancer, and ovarian cancer, who have exhausted standard therapy options. It evaluates LY4052031, an antibody-drug conjugate that targets Nectin-4 to deliver a topoisomerase I inhibitor, aiming to assess its safety, tolerability, and efficacy in these patients.

ClinicalTrials.gov ID: NCT06465069

A Dose-Escalation and Expansion Study of XB010 as a Single Agent and Combination Therapy in Subjects With Locally 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.

TrialFetch AI summary: The trial evaluates the investigational antibody-drug conjugate XB010, which targets the 5T4 antigen to inhibit tumor growth, in adults with locally advanced or metastatic solid tumors who lack alternative treatment options; it assesses XB010 as both a monotherapy and in combination with pembrolizumab across various tumor types including non-small cell lung cancer, hormone-receptor-positive and triple-negative breast cancer, head and neck, and esophageal squamous cell cancers.

ClinicalTrials.gov ID: NCT06545331

A Phase 1, Multicenter, Open-label, Dose-escalation Study Evaluating the Safety and Tolerability of Intravenous KK2269 Monotherapy and Combination Therapy With Docetaxel in Adult Participants With 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.

TrialFetch AI summary: This trial involves adult patients with advanced solid tumors, focusing on gastric, GEJ, esophageal adenocarcinomas, and NSCLC, testing KK2269, a bispecific antibody targeting CD40 and EpCAM, alone and in combination with docetaxel to assess safety and tolerability.

ClinicalTrials.gov ID: NCT06266299

A Phase 1a/1b Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-53038, a Pan-KRAS Inhibitor, as Monotherapy or in Combinations in Patients With Advanced or Metastatic Solid Tumors With KRAS Mutations or Amplifications

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.

TrialFetch AI summary: This trial enrolls adults with advanced or metastatic solid tumors harboring KRAS mutations (excluding G12R) or KRAS amplification, testing the investigational oral pan-KRAS inhibitor BGB-53038 as monotherapy or in combination with tislelizumab (for nonsquamous NSCLC) or cetuximab (for colorectal cancer). BGB-53038 selectively targets KRAS-mutated or amplified tumors, while sparing NRAS and HRAS.

ClinicalTrials.gov ID: NCT06585488

A Phase 1/1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 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.

TrialFetch AI summary: This trial enrolls adults with unresectable, locally advanced or metastatic solid tumors—including a wide range such as head and neck, lung, bladder, prostate, breast, colorectal, and others—who have progressed on or are intolerant to standard therapies. Patients receive MGC026, a B7-H3-targeted antibody-drug conjugate delivering a topoisomerase I inhibitor (exatecan), with cohorts in both dose escalation and expansion phases.

ClinicalTrials.gov ID: NCT06242470

A Phase 1/2a, Multicenter, First-in-human, Open-label Clinical Trial Evaluating MDX2001 Monotherapy in Patients 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.

TrialFetch AI summary: Eligible patients are adults with metastatic solid tumors (ECOG 0-1, measurable disease, adequate organ function) who will receive MDX2001, a tetraspecific antibody that engages T cells via CD3/CD28 and targets TROP2 and c-MET on tumor cells. The trial excludes individuals with major cardiac disease, active brain metastases, uncontrolled infections, or unresolved toxicities.

ClinicalTrials.gov ID: NCT06239194