Zimberelimab and Quemliclustat in Combination With Chemotherapy for the Treatment of Patients With Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT05688215
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Borderline Resectable Pancreatic Adenocarcinoma
  • Locally Advanced Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood and tissue samples
  • Computed Tomography — PROCEDURE
    Undergo a CT scan
  • Core Biopsy — PROCEDURE
    Undergo core biopsy
  • Fluorouracil — DRUG
    Given IV
  • Irinotecan — DRUG
    Given IV
  • Leucovorin — DRUG
    Given IV
  • Leucovorin Calcium — DRUG
    Given IV
  • Oxaliplatin — DRUG
    Given IV
  • Quemliclustat — DRUG
    Given intravenously (IV)
  • Zimberelimab — DRUG
    Given IV

Study Details

This phase I/II study tests how well zimberelimab and quemliclustat work in combination with chemotherapy (mFOLFIRINOX) in treating patients pancreatic adenocarcinoma that may or may not be able to be removed by surgery (borderline resectable) or that has spread to nearby tissue or lymph nodes (locally advanced). Immunotherapy with monoclonal antibodies, such as zimberelimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Quemliclustat acts as a blocker for adenosine. Adenosine is a chemical produced in the body that can lead to a decrease in the immune system's response towards cancer. Quemliclustat has the potential to decrease the amount of adenosine, allowing the immune system to recognize and act against the cancer. Chemotherapy drugs, such as oxaliplatin, irinotecan, leucovorin, 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. Giving chemotherapy in combination with zimberelimab and quemliclustat may kill more cancer cells than chemotherapy alone.

Key Dates

Start date
Mar 7, 2023
Status verified
May 2026
Primary completion
Dec 1, 2026
Completion
Mar 2, 2027

Study Design

Enrollment
56 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (zimberelimab, quemliclustat, chemotherapy)
    Patients receive zimberelimab IV, quemliclustat IV, oxaliplatin IV, leucovorin calcium IV, and inrinotecan IV on study. Patients undergo collection of blood samples and CT throughout the trial. Patients with borderline-resectable pancreatic cancer undergo collection of tissue samples. Patients with locally advanced pancreatic cancer undergo core biopsy.

Primary Outcome Measure

Incidence of adverse events (BPRC Cohort) [ Time Frame: From baseline measurement to 90 days after the last dose of study treatment. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yonemoto,LisaLos AngelesCalifornia90095
Lisa A. Yonemoto
[email protected]
310-582-4069
Zev A. Wainberg, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
Yonemoto,Lisa· Los Angeles, CA

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