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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-21

Study Completion Date

2027-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Biliary Tract Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HRS-4642 monotherapy arm

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

Group Type EXPERIMENTAL

HRS-4642 monotherapy

Intervention Type DRUG

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

combination therapy arm

Patients will receive HRS-4642 and adebrelimab combination therapy.

Group Type EXPERIMENTAL

HRS-4642 and adebrelimab combination therapy

Intervention Type DRUG

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

Interventions

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HRS-4642 monotherapy

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

Intervention Type DRUG

HRS-4642 and adebrelimab combination therapy

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No