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

NCT06620848 | Recruiting Phase 2

• 1 other identifier: BTC-2nd-IIT-HRS4642-SHR1316
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Tract Cancer

Keywords

KRAS G12D; Biliary Tract Cancer

Outcome Measures

Primary Outcomes (2)

• Objective response rate (ORR) by RECIST V1.1

  The ORR is defined as complete remission (CR) rate + partial remission (PR) rate by RECIST V1.1.

  up 2 years

• Adverse events(AEs), serious adverse events（SAEs）

  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).

  up 2 years

Secondary Outcomes (3)

• Disease control rate (DCR)

  up 2 years

• Progression-free survival (PFS)

  up 2 years

• Overall survival (OS)

  up 2 years

Study Arms (2)

HRS-4642 monotherapy arm

EXPERIMENTAL

Patients will receive HRS-4642 monotherapy at a fixed dose.

Drug: HRS-4642 monotherapy

combination therapy arm

EXPERIMENTAL

Patients will receive HRS-4642 and adebrelimab combination therapy.

Drug: HRS-4642 and adebrelimab combination therapy

Interventions

HRS-4642 monotherapy DRUG

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

HRS-4642 monotherapy arm

HRS-4642 and adebrelimab combination therapy DRUG

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

combination therapy arm

Eligibility Criteria

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

You may qualify if:

• years old, male or female.
• Histologically or cytologically confirmed diagnosis of advanced biliary tract cancer.
• 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).
• Have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
• ECOG performance status of 0-1.
• With a life expectancy of ≥3 months.
• Have adequate laboratory parameters and organ functions during the screening period.

You may not qualify if:

• Known history of hypersensitivity to any components of HRS-4642 or adebrelimab.
• 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.
• Patients with untreated or active central nervous system tumor metastasis.
• Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200020, China

RECRUITING

MeSH Terms

Conditions

Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Jia Fan, M.D

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

• Guoming Shi, M.D

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guoming Shi, M.D

CONTACT

13916969578; shi.guoming@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: November 21, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)