This is a Phase IB/II clinical trial designed to evaluate HRS-7172 in combination with antitumor drugs in participants with advanced pancreatic cancer harboring RAS mutations or amplifications. The study process includes a screening period (from signed informed consent to first dose), a treatment period (from first dose to last dose), and a follow-up period (safety and survival follow-up after last dose). A Safety Monitoring Committee (SMC), composed of the principal investigator and sponsor representatives, will be established during the study to review the safety and efficacy data generated. The SMC will make decisions on study-related matters, including but not limited to combination regimen dose exploration, combination regimen selection, efficacy expansion cohort selection, expansion initiation timing, and recommended dose for expansion (RDE). This study aims to evaluate the safety, tolerability, and efficacy of HRS-7172 in combination with other antitumor therapies in participants with advanced or metastatic pancreatic cancer harboring RAS mutations or amplifications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
HRS-7172 + AG + SHR-1316; low dose
HRS-7172 + AG + SHR-1316; high dose
HRS-7172 + AG; low/high dose
HRS-7172 + AG + SHR-1316; low/high dose
HRS-717 + HRS-4642+SHR-1316; low dose
HRS-717 + HRS-4642+SHR-1316; high dose
HRS-717 + HRS-4642; low/high dose
HRS-717 + HRS-4642+SHR-1316; low/high dose
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RDE in advanced pancreatic cancer with RAS mutation or amplification
Time frame: From the signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
Incidence and severity of adverse events (AEs) (per NCI-CTCAE V6.0 criteria)
Time frame: From the signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
ORR assessed by the investigator
Time frame: From the signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
Objective Response Rate (ORR) as assessed by the investigator
Time frame: From signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
Disease Control Rate (DCR) as assessed by the investigator
Time frame: From signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
Duration of Response (DoR) as assessed by the investigator
Time frame: From signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
Progression-Free Survival (PFS) as assessed by the investigator
Time frame: From signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
Overall Survival (OS)
Time frame: From signing of the informed consent form to the end of the safety follow-up. Estimated to be 2 years
Anti-Drug Antibodies (ADA)
Time frame: From pre-dose on C1D1 to 30 days after the last dose. Estimated to be 2 years
Incidence and severity of AEs
Time frame: From the participant's signing of the informed consent form to the end of the safety follow-up period. Estimated to be 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.