Treatment of advanced biliary tract tumors with HRS-4642 alone or with adebrelimab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of HRS-4642, both as a standalone treatment and in combination with adebrelimab, for patients suffering from advanced biliary tract cancer. Participants must have a confirmed diagnosis of unresectable or metastatic biliary tract tumors and have experienced progression or intolerance to prior systemic therapies. The study aims to determine the effectiveness of these treatments in managing the disease and improving patient outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai Zhongshan Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Jia Fan, M.D — Shanghai Zhongshan Hospital
• Study coordinator: Guoming Shi, M.D
• Email: shi.guoming@zs-hospital.sh.cn
• Phone: 13916969578

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.