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

NCT06591520 | Active Not Recruiting Phase 3

• 1 other identifier: AK112-309
• Study Type: interventional
• Target: 682
• Locations: 1 country
• Sites: 2

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.

Conditions

Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  OS is the time from randomization to death due to any cause.

  Up to approximately 2 years

Secondary Outcomes (6)

• Progression Free Survival (PFS)

  Up to approximately 2 years

• Objective Response Rate (ORR)

  Up to approximately 2 years

• Duration of Response (DoR)

  Up to approximately 2 years

• Disease Control Rate (DCR)

  Up to approximately 2 years

• Time to response (TTR)

  Up to approximately 2 years

Study Arms (2)

AK112 + Gemcitabine + Cisplatin

EXPERIMENTAL

Drug: AK112, Gemcitabine, Cisplatin

Durvalumab + Gemcitabine + Cisplatin

ACTIVE COMPARATOR

Drug: Durvalumab, Gemcitabine, Cisplatin

Interventions

AK112, Gemcitabine, Cisplatin DRUG

AK112 will be administered at a selected dose intravenously (IV) every three weeks (Q3W). Gemcitabine will be administered at 1000 mg/m2, D1, D8, Q3W, intravenously (IV) for 8 cycles. Cisplatin will be administered at 25 mg/m2, D1, D8, Q3W, intravenously (IV) for 8 cycles.

AK112 + Gemcitabine + Cisplatin

Durvalumab, Gemcitabine, Cisplatin DRUG

Durvalumab will be administered at 1500mg intravenously (IV) every three weeks (Q3W) for 8 cycles and followed by monotherapy every 4 weeks. Gemcitabine will be administered at 1000 mg/m2, D1, D8, Q3W, intravenously (IV) for 8 cycles. Cisplatin will be administered at 25 mg/m2, D1, D8, Q3W, intravenously (IV) for 8 cycles.

Durvalumab + Gemcitabine + Cisplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akeso: lead

Study Sites (2)

Harbin Medical University Cancer Hospital

Harbin, China

Location

Zhongshan Hospital, Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Gemcitabine; Cisplatin; durvalumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Wenting Li, MD

  Akeso

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2024
• First Posted: September 19, 2024
• Study Start: October 20, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

CN (2)