To hear about similar clinical trials, please enter your email below
Trial Title:
A Study of HRS-4642 Monotherapy or in Combination with Adebrelimab in the Treatment of Advanced Biliary Tract Tumors.
NCT ID:
NCT06620848
Condition:
Biliary Tract Cancer
Conditions: Official terms:
Biliary Tract Neoplasms
Conditions: Keywords:
KRAS G12D
Biliary Tract Cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HRS-4642 monotherapy
Description:
HRS-4642 will be administrated per dose level in which the patients are assigned.
Arm group label:
HRS-4642 monotherapy arm
Intervention type:
Drug
Intervention name:
HRS-4642 and adebrelimab combination therapy
Description:
HRS-4642 and adebrelimab will be administrated per dose level in which the patients are
assigned.
Arm group label:
combination therapy arm
Summary:
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Zhongshan Hospital
Address:
City:
Shanghai
Zip:
200020
Country:
China
Contact:
Last name:
Guoming Shi, M.D
Email:
shi.guoming@zs-hospital.sh.cn
Contact backup:
Last name:
Guoming Shi, M.D
Start date:
October 20, 2024
Completion date:
June 30, 2027
Lead sponsor:
Agency:
Shanghai Zhongshan Hospital
Agency class:
Other
Source:
Shanghai Zhongshan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06620848
