Recruiting NCT06620848
A Study of HRS-4642 Monotherapy or in Combination With Adebrelimab in the Treatment of Advanced Biliary Tract Tumors.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HRS-4642 monotherapy, HRS-4642 and adebrelimab combination therapy.
- Who it may be relevant to
- Registry conditions: Biliary Tract Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Study of HRS-4642 Monotherapy or in Combination With Adebrelimab in Patients With Advanced Biliary Tract Tumors.
Overview
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.
Interventions
- Drug HRS-4642 monotherapy
HRS-4642 will be administrated per dose level in which the patients are assigned. - Drug HRS-4642 and adebrelimab combination therapy
HRS-4642 and adebrelimab will be administrated per dose level in which the patients are assigned.
Primary outcome measures
- Objective response rate (ORR) by RECIST V1.1 [Time frame: up 2 years]
- Adverse events(AEs), serious adverse events（SAEs） [Time frame: up 2 years]
Secondary outcome measures (3)
- Disease control rate (DCR) [Time frame: up 2 years]
- Progression-free survival (PFS) [Time frame: up 2 years]
- Overall survival (OS) [Time frame: up 2 years]
Eligibility criteria
Inclusion criteria
- 18-75 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Zhongshan Hospital — Shanghai
Identifiers
NCT: NCT06620848 · BTC-2nd-IIT-HRS4642-SHR1316