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

Phase II Basket Trial of Intraperitoneal Paclitaxel Plus Systemic Therapy in Gastrointestinal Malignancies With Peritoneal Carcinomatosis (STOPGAP - B)

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 gastrointestinal adenocarcinoma and positive peritoneal cytology or peritoneal carcinomatosis, including gastric/GEJ, colorectal, appendiceal, and other digestive-tract cancers, receive intraperitoneal paclitaxel every 2 or 3 weeks with systemic chemotherapy. Paclitaxel is a microtubule-stabilizing taxane; the gastric/GEJ regimen includes IV paclitaxel, 5-fluorouracil, and leucovorin.

ClinicalTrials.gov ID: NCT07795749

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: Adults with measurable advanced or metastatic non-CNS solid tumors and ECOG 0–1 receive escalating intravenous doses of KK2269, an investigational EpCAM×CD40 bispecific antibody designed to activate CD40 near EpCAM-positive tumors. A combination cohort receives KK2269 plus docetaxel after prior systemic therapy for gastric, gastroesophageal junction, or esophageal adenocarcinoma or NSCLC; patients must be docetaxel-eligible and docetaxel-naive.

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: Adults with advanced or metastatic solid tumors harboring a KRAS mutation or high-level KRAS wild-type amplification receive the investigational oral pan-KRAS inhibitor BGB-53038 alone or with tislelizumab (anti–PD-1) for nonsquamous NSCLC or cetuximab (anti-EGFR) for colorectal cancer. The study has been terminated, in part because of a lack of promising efficacy.

ClinicalTrials.gov ID: NCT06585488

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: Adults with metastatic solid tumors, measurable disease, and ECOG performance status 0–1 receive intravenous MDX2001 monotherapy. MDX2001 is an investigational tetraspecific antibody that binds c-MET and TROP2 on tumors while engaging CD3 and providing CD28 costimulation to promote tumor-directed T-cell activity.

ClinicalTrials.gov ID: NCT06239194

A Phase I/II, Open-Label, Multicenter Study of ALE.P02 (Claudin-1 Targeted Antibody-Drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+Squamous 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: Adults with CLDN1-positive, unresectable or metastatic squamous NSCLC, head and neck, esophageal, or cutaneous carcinoma who are refractory to or intolerant of standard systemic therapy receive intravenous ALE.P02 monotherapy. ALE.P02 is an investigational claudin-1–targeted antibody–drug conjugate that delivers a tubulin-inhibiting payload.

ClinicalTrials.gov ID: NCT06747585

A Phase I/II, Dose-escalation and Dose-optimization Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of MT-4561 in Patients With Various Advanced Solid Tumors and to Evaluate Effect of MT-4561 on Pharmacokinetics of Oral Midazolam

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: Adults with selected advanced solid tumors, measurable disease, and ECOG performance status 0–1 receive once-weekly intravenous MT-4561, an investigational drug designed to degrade BRD4. Dose escalation is followed by planned dose optimization and an assessment of MT-4561’s effect on oral midazolam pharmacokinetics.

ClinicalTrials.gov ID: NCT06943521