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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJonsson Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

Male or female ≥ 18 years of age and willing and able to provide informed consent

Cholangiocarcinoma

Borderline resectable/locally advanced cholangiocarcinoma: to be defined as unresectable disease on evaluation by a hepatobiliary multi-disciplinary tumor board/surgeon based on tumor size/location, vascular involvement, and absence of extrahepatic metastasis.

Metastatic cholangiocarcinoma: Patients with metastatic cholangiocarcinoma patient who have not received prior systemic therapy

Disqualifiers

Previous treatment with any of planned study drugs in cholangiocarcinoma, though patients with one cycle of gemcitabine/cisplatin/durvalumab will be considered eligible

Previous treatment with any of planned study drugs in pancreatic adenocarcinoma, though patients with one cycle of FOLFIRINOX will be considered eligible

Peripheral neuropathy > grade 2

Known status of HIV which is not well-controlled (CD4 < 300) at the time of study eligibility. Patients with controlled and treated HIV/hepatitis C virus (HCV) and an undetectable viral load are allowed

Trial design

Treatments tested in this trial

  • Biopsy Procedure
  • Cisplatin
  • Computed Tomography
  • Durvalumab
  • Fluorouracil
  • Gemcitabine
  • Irinotecan
  • Leucovorin
  • Ligritinib
  • Magnetic Resonance Imaging
  • Oxaliplatin
  • Zimberelimab

Treatment groups

46 Participants
are divided into 2 treatment groups

Locations

1
UCLA / Jonsson Comprehensive Cancer Center90095, Los AngelesCalifornia, United States

Sponsors and collaborators

Jonsson Comprehensive Cancer Center

Lead sponsor