A Phase 1/2 interventional study of JAB-23E73 tablet，nab-paclitaxel，gemcitabine in Metastatic Pancreatic Ductal Adenocarcinoma, sponsored by Jacobio Pharmaceuticals Co., Ltd.. Recruiting at 13 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Jacobio Pharmaceuticals Co., Ltd. · Phase 1/2, Interventional, and Treatment
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.
This is a phase Ib/III, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antineoplastic activity of pan-KRAS inhibitor JAB-23E73 in combination with nab-paclitaxel and gemcitabine in treatment-naive participants with metastatic PDAC.
Phase Ib study：an open-label study, including dose escalation and backfill cohorts, with approximately 40-80 participants planned to be enrolled (including approximately 20-50 participants in the backfill cohort),Aiming to determine the recommended phase III dose [RP3D] within investigated patient population groups.
Phase III: Following confirmation of the efficacy and safety of JAB-23E73 in combination with the AG regimen in Phase Ib, a Phase III trial will be initiated to evaluate the efficacy and safety of JAB-23E73 plus AG versus AG alone for the treatment of metastatic PDAC.
1.Written informed consent signed by the participant or the participant's legally authorized representative must be obtained prior to performing any study-related procedures. 2. Histologically or cytologically confirmed metastatic PDAC.
3. No prior systemic antitumor therapy for advanced disease (treatment-naïve). 4. Presence of KRAS gene alterations: be enrolled upon approval by the sponsor).
5. ECOG performance status score of 0 or 1. 6. Adequate organ function.
Exclusion Criteria:
Drug: JAB-23E73 tablet，nab-paclitaxel，gemcitabine
Orally, intravenous (IV) infusion
Dose limiting toxicities (DLT)
The number and proportion of participants who experienced dose-limiting toxicities (DLT).
Time frame: Up to 28 days
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.
Time frame: Up to approximately 3 years
ORR
Objective response rate, ORR is defined as the proportion of participants with confirmed complete response or partial response
Time frame: Up to approximately 3 years
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
Time frame: Up to approximately 3 years
TTR
Time to Response, TTR is defined as the time from the first dose of study treatment to the first documented CR or PR.
Time frame: Up to approximately 3 years
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.
Time frame: Up to approximately 3 years
DCR
Disease Control Rate, DCR is defined as the proportion of participants whose best overall response is CR, PR, or SD..
Time frame: Up to approximately 3 years
OS
Overall Survival , OS is defined as the time from the first dose of study treatment to death from any cause.
Time frame: Up to approximately 3 years
PK
maximum plasma concentration (Cmax)
Time frame: Up to approximately 3 years
PK
area under the plasma concentration-time curve (AUC)
Time frame: Up to approximately 3 years
PK
trough plasma concentration (Ctrough)
Time frame: Up to approximately 3 years
Plan to share: No
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Jacobio Pharmaceuticals Co., Ltd.