Study on Gemcitabine, Cisplatin, AB680, and AB122 for First-Line Treatment of Advanced Biliary Tract Cancers

Sponsor: Nataliya Uboha

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06048133

Provider View

This clinical trial is testing a new combination of drugs, including gemcitabine, cisplatin, zimberelimab (AB122), and quemliclustat (AB680), to treat patients with advanced biliary tract cancers who have not received prior treatment. The study will start with a safety phase involving 6 participants to ensure the treatment is safe before continuing with more participants.

Patient Parameters

Program Overview

This phase 2 study is exploring a new treatment combination for advanced biliary tract cancers (BTC) that have not been treated before. The treatment includes four drugs: gemcitabine, cisplatin, zimberelimab (AB122), and quemliclustat (AB680). Initially, 6 participants will receive the treatment to check for any early safety concerns. After 4 cycles of treatment (about 6 months), cisplatin will be stopped, but the other three drugs will continue. The study will include up to 39 participants in total, and treatment will continue until the cancer progresses or side effects become too severe.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced biliary tract cancer (BTC) that has not been treated with systemic therapy for advanced disease.
  • Must be 18 years or older.
  • Able to provide written consent and agree to share personal health information.
  • Have a performance status score of 0 to 2, indicating good overall health.
  • Have measurable or evaluable cancer as per specific medical criteria.
  • Have adequate organ function based on medical tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 120 days after the last dose.
  • Men must agree to use effective contraception during the study and for 120 days after the last dose.
  • Must be able to understand and follow study procedures.

Exclusion Criteria

  • Previous treatment with gemcitabine, cisplatin, or immune checkpoint inhibitors for BTC.
  • Allergies to proteins or ingredients in the study medications.
  • Active autoimmune disease requiring treatment in the past 2 years, except for certain conditions like asthma.
  • History of organ or bone marrow transplant.
  • Pregnant or breastfeeding women.
  • Other cancers that could interfere with the study.
  • Untreated cancer spread to the brain.
  • Medical conditions that could make the treatment unsafe, such as lung disease or active infections.
  • Recent major surgery or trauma.
  • Recent palliative radiation therapy.
  • Mental health or substance abuse issues that could affect participation.
  • Significant dementia or mental conditions affecting consent.
  • Recent use of live vaccines.

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