The purpose of this study is to determine the safety and efficacy of pan KRAS inhibitor JAB-23E73 in combination with nab-paclitaxel and gemcitabine in participants with metastatic PDAC harboring KRAS gene alterations.
None
Inability to swallow oral medications or the presence of gastrointestinal dysfunction or disease that may significantly alter drug absorption.
A history of another malignancy within 2 years prior to the first dose, histologically distinct from the cancer under study, except for carcinoma in situ of the cervix, superficial non-invasive bladder cancer, or adequately treated stage I non-melanoma skin cancer.
Prior treatment with KRAS G12C inhibitors, KRAS G12D inhibitors, pan-KRAS/pan RAS inhibitors, or other agents of the same class.
Women who are pregnant or breast-feeding.
Sequential
JAB-23E73 tablet，nab-paclitaxel，gemcitabine
DrugOrally, intravenous (IV) infusion
Dose limiting toxicities (DLT)
The number and proportion of participants who experienced dose-limiting toxicities (DLT).
Adverse events.safety evaluation
The types, incidence, severity, and outcomes of adverse events and serious adverse events evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
ORR
Objective response rate, ORR is defined as the proportion of participants with confirmed complete response or partial response
DOR
Duration of response, DOR is defined as the time from the first documented CR or PR to the first occurrence of disease progression or death from any cause, whichever occurs first
TTR
Time to Response, TTR is defined as the time from the first dose of study treatment to the first documented CR or PR.
PFS
Progression-Free Survival , PFS is defined as the time from the first dose of study treatment to the first documented disease progression or death from any cause, whichever occurs first.
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