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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT07619313
Phase
PHASE1
Status
Not Yet Recruiting

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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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo tissue biopsy
  • Cisplatin — DRUG
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Durvalumab — BIOLOGICAL
    Given IV
  • Fluorouracil — DRUG
    Given IV
  • Gemcitabine — DRUG
    Given IV
  • Irinotecan — DRUG
    Given IV
  • Leucovorin — DRUG
    Given IV
  • Ligritinib — DRUG
    Given PO
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Oxaliplatin — DRUG
    Given IV
  • Zimberelimab — DRUG
    Give IV

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2028

Study Design

Enrollment
46 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort I (AB801, gemcitabine, cisplatin, durvalumab)
    Patients with cholangiocarcinoma receive AB801 PO QD, gemcitabine and cisplatin IV over 30 minutes on days 1 and 8 and durvalumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI throughout the trial as well as tissue biopsy on trial.
  • Experimental: Cohort II (AB801, zimberelimab, FOLFIRINOX)
    Patients with pancreatic cancer receive AB801 PO QD and zimberelimab IV over 60 minutes on day 1 of each cycle. Patients receive oxaliplatin IV over 120 minutes, leucovorin IV, and irinotecan IV on days 1 and 15 of each cycle and fluorouracil IV over 46 hours on days 1 and 15 of each cycle. Cycles repeat every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI throughout the trial as well as tissue biopsy on trial.

Primary Outcome Measure

Incidence of dose limiting toxicities [ Time Frame: During first cycle of the dose escalation phase (cycle length = 21 days for cohort I and 28 days for cohort II) ]

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095
Lee S. Rosen
[email protected]
Lee S. Rosen (PRINCIPAL_INVESTIGATOR)

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By research site
UCLA / Jonsson Comprehensive Cancer Center· Los Angeles, CA

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