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.

HealthScout AI summary: This trial enrolls adults with metastatic or unresectable solid tumors (excluding NSCLC) harboring activating HER2 mutations, who have progressed on standard therapy or have no satisfactory alternatives. Patients receive BAY2927088, an oral reversible tyrosine kinase inhibitor targeting mutant HER2 and EGFR.

ClinicalTrials.gov ID: NCT06760819

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.

HealthScout AI summary: This trial enrolls adults (and selected adolescents) with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation, who have progressed after at least one prior therapy, to receive rezatapopt (PC14586)—a selective oral p53 reactivator targeting the Y220C mutant—as monotherapy. Patients must have ECOG 0-1 and measurable disease; cohorts include ovarian, lung, breast, endometrial, and other solid tumors, with KRAS wild-type status required for some.

ClinicalTrials.gov ID: NCT04585750

A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ARV-806 in Participants With KRAS G12D Mutated 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.

HealthScout AI summary: This trial enrolls adults with advanced solid tumors or pancreatic ductal adenocarcinoma harboring a KRAS G12D mutation who have received prior standard therapies, testing ARV-806, an investigational IV protein degrader specifically targeting mutant KRAS G12D. Patients with prior KRAS G12D/pan-KRAS inhibitor exposure or uncontrolled comorbidities are excluded.

ClinicalTrials.gov ID: NCT07023731

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

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 advanced or metastatic solid tumors harboring homozygous MTAP deletions who have progressed on standard therapy are eligible for treatment with TNG462, a selective PRMT5 inhibitor targeting MTAP-deleted tumor cells, either as monotherapy or in combination with pembrolizumab.

ClinicalTrials.gov ID: NCT05732831

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.

HealthScout 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.

HealthScout 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 I/II Study of Peposertib (M3814) and Avelumab in Combination With Hypofractionated Radiation in Patients With Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies

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.

HealthScout AI summary: Adults with metastatic/unresectable solid tumors (phase I) and, in phase II, cholangiocarcinoma or gallbladder cancer after progression on gemcitabine/cisplatin plus durvalumab or pembrolizumab, eligible for palliative hypofractionated RT and with separate measurable non-irradiated disease. Treatment is hypofractionated RT plus avelumab (anti–PD-L1) with or without peposertib (M3814/nedisertib), an oral DNA-PK inhibitor and radiosensitizer given continuously each 28-day cycle.

ClinicalTrials.gov ID: NCT04068194

Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types

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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic, immunologically cold solid tumors—including biliary tract, HR-negative/HER2-positive breast, platinum-resistant ovarian, pancreatic adenocarcinoma, soft tissue sarcoma, castrate-resistant prostate, neuroendocrine, and vulvar cancers—who have progressed on or are intolerant to standard therapies. Patients receive atezolizumab (anti-PD-L1 immune checkpoint inhibitor) combined with tivozanib (oral VEGFR tyrosine kinase inhibitor), aiming to improve tumor response rates in this refractory population.

ClinicalTrials.gov ID: NCT05000294

FOLFOX in Combination With Binimetinib as 2nd Line Therapy for Patients With Advanced Biliary Tract Cancers With MAPK Pathway Alterations: A ComboMATCH Treatment Trial

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 or recurrent biliary tract cancers (cholangiocarcinoma or gallbladder) that progressed after gemcitabine-based first-line therapy and harbor MAPK pathway alterations (RAS/RAF/MEK/ERK; excluding BRAF V600E) are randomized to mFOLFOX6 with or without binimetinib, an oral MEK1/2 inhibitor targeting MAPK signaling. Requires measurable disease and adequate cardiac/organ function; prior MEK or direct KRAS inhibitors excluded.

ClinicalTrials.gov ID: NCT05564403

Safety of Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Biliary Tract Cancer Patients With Peritoneal Metastases

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 untreated advanced biliary tract cancer (cholangiocarcinoma or gallbladder) and peritoneal metastases, ECOG 0–1, receive standard gemcitabine/cisplatin plus intraperitoneal nab-paclitaxel delivered via PIPAC at specified cycles. Nab-paclitaxel (albumin-bound paclitaxel; microtubule inhibitor) is aerosolized under pressure laparoscopically to enhance peritoneal penetration, with the study focused on safety and feasibility.

ClinicalTrials.gov ID: NCT05285358