AK112 Combined With Chemotherapy Versus Durvalumab Combined With Chemotherapy in Advanced Biliary Tract Cancer

Phase 3

Not yet recruiting

• Conditions: Biliary Tract Cancer
• Interventions: Drug: AK112, Gemcitabine, Cisplatin; Drug: Durvalumab, Gemcitabine, Cisplatin

• Registration Number: NCT06591520
• Lead Sponsor: Akeso

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-08
• Study First Submitted QC: 2024-09-08
• Last Update Submitted: 2024-09-08
• Study First Posted: 2024-09-11
• Last Update Posted: 2024-09-11
• Study Start: 2024-10
• Primary Completion: 2027-07
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 682

Inclusion Criteria

• Be able and willing to provide written informed consent.
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• 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) v1.1.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AK112 + Gemcitabine + Cisplatin	AK112, Gemcitabine, Cisplatin	-
Durvalumab + Gemcitabine + Cisplatin	Durvalumab, Gemcitabine, Cisplatin	-

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to approximately 2 years	OS is the time from randomization to death due to any cause.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	Up to approximately 2 years	PFS is defined as the time from randomization to the first documented disease progression (per RECIST v1.1 criteria) assessed by investigators or death due to any cause, whichever occurs first.
Objective Response Rate (ORR)	Up to approximately 2 years	ORR is the proportion of subjects with complete response(CR) or partial response(PR) , assessed by investigators based on RECIST v1.1.
Duration of Response (DoR)	Up to approximately 2 years	The DoR was defined as the time from the date of first documented OR (confirmed CR or confirmed PR) until date of documented progression (PD) based on investigator assessments by using RECIST version 1.1 or death in absence of disease progression.
Disease Control Rate (DCR)	Up to approximately 2 years	DCR is the proportion of subjects with complete response(CR) , partial response (PR) or stable disease (SD) , assessed by investigators based on RECIST v1.1.
Time to response (TTR)	Up to approximately 2 years	TTR is defined as the time to response based on RECIST v1.1.
Adverse Events (AEs)	Up to approximately 2 years	An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Trial Locations

Locations (2)

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, China

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, China