Clinical Trials for Gallbladder 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: Adults with unresectable or metastatic solid tumors other than NSCLC that harbor an activating HER2 mutation are eligible after appropriate standard therapy or when no satisfactory alternative exists; prior HER2 tyrosine kinase inhibitor treatment and active brain metastases are excluded. All participants receive oral sevabertinib, a reversible HER2-directed tyrosine kinase inhibitor, 20 mg twice daily.

ClinicalTrials.gov ID: NCT06760819

Phase III, Randomized, Open-label, Global, Multicenter Study of Rilvegostomig or Durvalumab in Combination With Chemotherapy as a First-line Treatment for Patients With Advanced Biliary Tract Cancer (ARTEMIDE-Biliary02)

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 patients with previously untreated, unresectable locally advanced or metastatic cholangiocarcinoma or gallbladder adenocarcinoma and ECOG performance status 0–1. It compares first-line gemcitabine/cisplatin plus rilvegostomig, an investigational PD-1/TIGIT bispecific antibody, with gemcitabine/cisplatin plus durvalumab.

ClinicalTrials.gov ID: NCT07221253

A Phase 3, Multicenter, Randomized, Open-label, Study Evaluating the Efficacy and Safety of Nanvuranlat in Patients With Previously Treated Advanced Biliary Tract Cancer

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 locally advanced or metastatic cholangiocarcinoma or gallbladder cancer, ECOG 0–1, and progression after one platinum-based regimen are randomized to intravenous nanvuranlat, a LAT1 amino-acid transporter inhibitor, or physician’s choice of FOLFOX, FOLFIRI, or best supportive care.

ClinicalTrials.gov ID: NCT07265674

A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

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.

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: Patients with previously treated, locally advanced or metastatic TP53 Y220C–mutant solid tumors and ECOG performance status 0–1 may be eligible; the enrolling portion requires measurable disease and excludes tumors with a KRAS single-nucleotide variant. Participants receive oral rezatapopt, an investigational small molecule that stabilizes Y220C-mutant p53 to restore tumor-suppressor activity; earlier cohorts also evaluated rezatapopt with pembrolizumab.

ClinicalTrials.gov ID: NCT04585750

A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Anti-tumor Activity of TNG462 as a Single Agent and in Combination in Patients With MTAP-deleted Advanced or Metastatic 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: Adults with previously treated, unresectable locally advanced or metastatic solid tumors and confirmed MTAP loss receive oral vopimetostat (TNG462), an investigational PRMT5 inhibitor designed to exploit methylthioadenosine accumulation in MTAP-deleted tumors. Some cohorts receive it with the anti–PD-1 antibody pembrolizumab, including an NSCLC expansion cohort.

ClinicalTrials.gov ID: NCT05732831

A Phase 1a/1b Multicenter, Open-label Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of PLN-101095 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Advanced or Metastatic Solid Tumors Who Have Disease Progression While on Pembrolizumab

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: Adults with measurable advanced or metastatic solid tumors that progressed after at least 3 months of pembrolizumab, and who have no effective treatment options, receive oral PLN-101095 alone or with continued pembrolizumab. PLN-101095 inhibits αvβ8 and αvβ1 integrins to reduce activation of immunosuppressive TGF-β in the tumor microenvironment.

ClinicalTrials.gov ID: NCT06270706

Locally ablatIVe thErapy for oLigo-progressive gastrOintestiNal maliGnancies (LIVELONG)

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 metastatic GI cancers (esophagus/GEJ/gastric, small bowel, colorectal/appendiceal, biliary, HCC, pancreatic/ampullary) on a benefiting systemic regimen who develop up to 5 new/progressing lesions receive lesion-directed local ablation (SABR or IR ablation) while continuing the same systemic therapy. Aims to control oligoprogression and delay systemic therapy change; excludes contraindications to ablation or active brain progression.

ClinicalTrials.gov ID: NCT06101277

An Open-label Randomized Trial of the Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy Alone for Advanced HER2-positive Biliary Tract Cancer

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 unresectable/metastatic HER2-positive biliary tract cancer (gallbladder or cholangiocarcinoma; ECOG 0–1) receiving first-line cisplatin/gemcitabine ± durvalumab or pembrolizumab are randomized to add zanidatamab versus standard therapy alone, with primary efficacy evaluated in IHC 3+ tumors. Zanidatamab is a bispecific, bi-epitopic anti-HER2 antibody designed to enhance receptor clustering/internalization and immune-mediated cytotoxicity.

ClinicalTrials.gov ID: NCT06282575

A Phase II Trial of Trifluridine/Tipiracil Plus Oxaliplatin in Patients With Advanced or Metastatic Biliary Tract Cancer Following First-Line Therapy

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: Enrolling adults with unresectable/metastatic cholangiocarcinoma or gallbladder carcinoma (ampullary excluded) who have had exactly one prior systemic regimen for advanced disease and progressed or were intolerant (ECOG 0–1, measurable disease). Participants receive second-line trifluridine/tipiracil (oral nucleoside analog incorporated into DNA plus thymidine phosphorylase inhibitor to increase exposure) combined with IV oxaliplatin (DNA-crosslinking platinum) in 14-day cycles until progression or unacceptable toxicity.

ClinicalTrials.gov ID: NCT07146646

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