Phase
Condition
Biliary Tract Cancer
Digestive System Neoplasms
Gall Bladder Cancer
Treatment
HRS-4642 monotherapy
HRS-4642 and adebrelimab combination therapy
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
18-75 years old, male or female.
Histologically or cytologically confirmed diagnosis of advanced biliary tractcancer.
Unresectable or metastatic advanced patients with progression or intolerance for ≥one line of systemic therapy, including patients who metastasize during or within 6months after neoadjuvant or adjuvant therapy (adjuvant therapy or neoadjuvanttherapy must include gemcitabine-based chemotherapy).
Have at least one measurable lesion according to the Response Evaluation Criteria inSolid 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
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 clinicaltrials) 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 thestudy early as judged by investigators.
Study Design
Connect with a study center
Shanghai Zhongshan Hospital
Shanghai, Shanghai 200020
ChinaActive - Recruiting
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