Clinical trial · Interventional
A Study of HRS-4642 Monotherapy or in Combination With Adebrelimab in the Treatment of Advanced Biliary Tract Tumors.
A Study of HRS-4642 Monotherapy or in Combination With Adebrelimab in Patients With Advanced Biliary Tract Tumors.
NCT06620848CI-TRIAL-00088018recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HRS-4642 and adebrelimab combination therapy | Drug | — | UNRESOLVED |
| HRS-4642 monotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HRS-4642 monotherapy arm
- description
- Patients will receive HRS-4642 monotherapy at a fixed dose.
- interventionNames
- Drug: HRS-4642 monotherapy
- type
- EXPERIMENTAL
- label
- combination therapy arm
- description
- Patients will receive HRS-4642 and adebrelimab combination therapy.
- interventionNames
- Drug: HRS-4642 and adebrelimab combination therapy
Primary outcomes (2)
- measure
- Objective response rate (ORR) by RECIST V1.1
- timeFrame
- up 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.