AB801 in Combination With Chemotherapy and Immunotherapy for the Treatment of Patients With Borderline Resectable, Locally Advanced or Metastatic Cholangiocarcinoma or Pancreatic Cancer

Summary

This phase I trial tests the safety, side effects, best dose and effectiveness of AB801 in combination with chemotherapy and immunotherapy in treating patients with cholangiocarcinoma or pancreatic adenocarcinoma that may be removed by surgery (borderline resectable), that has spread to nearby tissue or lymph nodes (locally advanced), or that has spread from where it first started (primary site) to other places in the body (metastatic). AB801 is a drug designed to block a protein called AXL. AXL is found on the surface of certain cancer cells and plays an important role in helping tumors grow, spread to other parts of the body, and avoid the immune system. It is thought to contribute to resistance against common cancer treatments such as chemotherapy, radiation and immunotherapy. In many cancers, including cholangiocarcinoma and pancreatic adenocarcinoma, AXL is overactive and associated with worse outcomes. AB801 inhibits AXL which may make cancer cells more sensitive to chemotherapy and allow immune cells to better recognize and attack the tumor. Chemotherapy drugs, such as gemcitabine, cisplatin, oxaliplatin, irinotecan, leucovrin and fluorouracil, work in different ways to stop the growth of cancer cells either by killing the cells, by stopping them from dividing or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as durvalumab and zimberelimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving AB801 in combination with chemotherapy and immunotherapy may better treat patients with borderline resectable, locally advanced or metastatic cholangiocarcinoma or pancreatic adenocarcinoma.

Conditions

• Borderline Resectable Pancreatic Ductal Adenocarcinoma
• Locally Advanced Cholangiocarcinoma
• Locally Advanced Pancreatic Adenocarcinoma
• Metastatic Cholangiocarcinoma
• Metastatic Pancreatic Adenocarcinoma
• Stage II Pancreatic Cancer AJCC v8
• Stage III Pancreatic Cancer AJCC v8
• Stage IV Pancreatic Cancer AJCC v8

Interventions

PROCEDURE

Biopsy Procedure

Undergo tissue biopsy

DRUG

Cisplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT

BIOLOGICAL

Durvalumab

Given IV

DRUG

Fluorouracil

Given IV

DRUG

Gemcitabine

Given IV

DRUG

Irinotecan

Given IV

DRUG

Leucovorin

Given IV

DRUG

Ligritinib

Given PO

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Oxaliplatin

Given IV

DRUG

Zimberelimab

Give IV

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Lee S Rosen · UCLA / Jonsson Comprehensive Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-01

Primary Completion

2027-06-01

Completion

2028-06-01

FDA Drug

Yes

Countries

• United States

Study Locations