Biliary Tract Cancer
Conditions
Keywords
KRAS G12D, Biliary Tract Cancer
Brief 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.
Interventions
DRUGHRS-4642 monotherapy
HRS-4642 will be administrated per dose level in which the patients are assigned.
DRUGHRS-4642 and adebrelimab combination therapy
HRS-4642 and adebrelimab will be administrated per dose level in which the patients are assigned.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) by RECIST V1.1 | up 2 years | The ORR is defined as complete remission (CR) rate + partial remission (PR) rate by RECIST V1.1. |
| Adverse events(AEs), serious adverse events（SAEs） | up 2 years | AEs and SAEs occurred from the first dose of treatment to 30 days after the last dose of HRS-4642 or 90 days after the last dose of adebrelimab (whichever comes late). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate (DCR) | up 2 years | The DCR is defined as complete remission (CR) rate + partial remission (PR) rate + stable disease (SD). |
| Progression-free survival (PFS) | up 2 years | PFS is defined as Time from the date of enrollment to of disease |
| Overall survival (OS) | up 2 years | OS is defined as time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive. |
Countries
China
Contacts
Primary ContactGuoming Shi, M.D
Outcome results
None listed