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Recruiting Phase 2

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

NCT06620848 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2024-11-21
Last updated
2025-04-02

Condition(s) studied

Biliary Tract Cancer

Investigational drug(s) / intervention(s)

HRS-4642 monotherapy →HRS-4642 and adebrelimab combination therapy

HRS-4642 monotherapy: HRS-4642 will be administrated per dose level in which the patients are assigned.

HRS-4642 and adebrelimab combination therapy: HRS-4642 and adebrelimab will be administrated per dose level in which the patients are assigned.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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).

Trial sites (1)

FacilityCityRegionStatus
Shanghai Zhongshan Hospital Shanghai Shanghai Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06620848 on ClinicalTrials.gov ↗ ← All trials in China