A Study of HRS-4642 Monotherapy or in Combination With Adebrelimab in the Treatment of Advanced Biliary Tract Tumors.

Phase 2

Recruiting

• Conditions: Biliary Tract Cancer
• Interventions: Drug: HRS-4642 monotherapy; Drug: HRS-4642 and adebrelimab combination therapy

• Registration Number: NCT06620848
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

The study was designed to evaluate the efficacy and safety of HRS-4642 monotherapy or in combination with adebrelimab in the treatment of advanced biliary tract tumor patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-26
• Study First Submitted QC: 2024-09-27
• Study First Posted: 2024-10-01
• Study Start: 2024-11-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-02
• Primary Completion: 2026-12-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

1. 18-75 years old, male or female.
2. Histologically or cytologically confirmed diagnosis of advanced biliary tract cancer.
3. Unresectable or metastatic advanced patients with progression or intolerance for ≥ one line of systemic therapy, including patients who metastasize during or within 6 months after neoadjuvant or adjuvant therapy (adjuvant therapy or neoadjuvant therapy must include gemcitabine-based chemotherapy).
4. Have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
5. ECOG performance status of 0-1.
6. With a life expectancy of ≥3 months.
7. Have adequate laboratory parameters and organ functions during the screening period.

Exclusion Criteria

1. Known history of hypersensitivity to any components of HRS-4642 or adebrelimab.
2. Prior anti-tumor chemotherapy within 4 weeks before the study drug administration. Small molecular targeted drugs (including oral targeted drugs for other clinical trials) with a half-life of less than 5 or 7 days from the first medication.
3. Patients with untreated or active central nervous system tumor metastasis.
4. Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HRS-4642 monotherapy arm	HRS-4642 monotherapy	Patients will receive HRS-4642 monotherapy at a fixed dose.
combination therapy arm	HRS-4642 and adebrelimab combination therapy	Patients will receive HRS-4642 and adebrelimab combination therapy.

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR) by RECIST V1.1	up 2 years	The ORR is defined as complete remission (CR) rate + partial remission (PR) rate by RECIST V1.1.
Adverse events(AEs), serious adverse events（SAEs）	up 2 years	AEs and SAEs occurred from the first dose of treatment to 30 days after the last dose of HRS-4642 or 90 days after the last dose of adebrelimab (whichever comes late).

Secondary Outcome Measures

Name	Time	Method
Disease control rate (DCR)	up 2 years	The DCR is defined as complete remission (CR) rate + partial remission (PR) rate + stable disease (SD).
Progression-free survival (PFS)	up 2 years	PFS is defined as Time from the date of enrollment to of disease
Overall survival (OS)	up 2 years	OS is defined as time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive.

Trial Locations

Locations (1)

Shanghai Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China