A Randomized, Controlled, Multi-center Phase III Study of AK112 Combined With Gemcitabine Plus Cisplatin Versus Durvalumab Combined With Gemcitabine Plus Cisplatin as the First-line Treatment for Patients With Advanced Biliary Tract Cancer

Akeso2 sites in 1 country682 target enrollmentOctober 20, 2024

ConditionsBiliary Tract Cancer

InterventionsAK112, Gemcitabine, Cisplatin Durvalumab, Gemcitabine, Cisplatin

DrugsAK112, Gemcitabine, Cisplatin Durvalumab, Gemcitabine, Cisplatin

Overview

Phase: Phase 3
Intervention: AK112, Gemcitabine, Cisplatin
Conditions: Biliary Tract Cancer
Sponsor: Akeso
Enrollment: 682
Locations: 2
Primary Endpoint: Overall Survival (OS)
Status: Active, not recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase 3 study. All subjects are patients with unresectable locally advanced or metastatic biliary tract cancer (BTC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of AK112 in combination with chemotherapy versus durvalumab in combination with chemotherapy in patients with unresectable locally advanced or metastatic BTC.

Registry

clinicaltrials.gov

Start Date

October 20, 2024

End Date

December 1, 2027

Last Updated

3 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Akeso

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Be able and willing to provide written informed consent.
•Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
•Has a life expectancy of at least 3 months.
•Has a histologically or cytologically confirmed diagnosis of biliary tract cancer (BTC).
•Has no prior systemic anti-tumor therapy for unresectable locally advanced or metastatic BTC.
•Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.
•Has adequate organ function.

Exclusion Criteria

•Has other malignancies within 5 years prior to enrollment.
•Is currently participating in a study of an investigational agent or using an investigational device.
•Has known active central nervous system (CNS) metastases.
•Has an active autoimmune disease that has required systemic treatment in the past 2 years.
•Has an active infection requiring systemic therapy.
•Has known active Hepatitis B or Hepatitis C.
•History of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to enrollment.
•Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
•Has received a live virus vaccine within 30 days of the planned first dose of study therapy.
•Has any concurrent medical condition that, in the opinion of the Investigator, would complicate or compromise compliance with the study or the well-being of the subject.