Study of JAB-23E73 in Combination With Chemotherapy in Participants With Metastatic PDAC Harboring KRAS Gene Alterations
The registry record from ClinicalTrials.gov (public domain): summary, interventions, outcomes and eligibility. Questions are answered only with quotes from this document. Source: ClinicalTrials.gov, retrieved 2026-11-05.
Ongoing
Record metadata
- Phase
- Phase 1 / Phase 2
- Status
- Recruiting
- Start
- 2026-07-16
- End
- 2030-12-31
- Enrollment
- 80
- Sites
- 13
- Sponsor class
- INDUSTRY
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Source text
Brief summary · public domain (ClinicalTrials.gov) · T1
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.
Detailed description · public domain (ClinicalTrials.gov) · T1
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.
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: JAB-23E73 tablet，nab-paclitaxel，gemcitabine. Orally, intravenous (IV) infusion
Arm · public domain (ClinicalTrials.gov) · T1
Dose escalation/backfill (experimental):
Primary outcome · public domain (ClinicalTrials.gov) · T1
Dose limiting toxicities (DLT). The number and proportion of participants who experienced dose-limiting toxicities (DLT). Time frame: Up to 28 days.
Primary outcome · public domain (ClinicalTrials.gov) · T1
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.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
ORR. Time frame: Up to approximately 3 years.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
DOR. Time frame: Up to approximately 3 years.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
TTR. Time frame: Up to approximately 3 years.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
PFS. Time frame: Up to approximately 3 years.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
DCR. Time frame: Up to approximately 3 years.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
OS. Time frame: Up to approximately 3 years.
Eligibility · public domain (ClinicalTrials.gov) · T1
Inclusion Criteria: 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: 1. Inability to swallow oral medications or the presence of gastrointestinal dysfunction or disease that may significantly alter drug absorption. 2. 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. 3. Prior treatment with KRAS G12C inhibitors, KRAS G12D inhibitors, pan-KRAS/pan RAS inhibitors, or other agents of the same class. 4. Women who are pregnant or breast-feeding. 5. Participants who have progressive disease or recurrence during neoadjuvant or adjuvant treatment, or within 6 months after the last dose of medication.
Enrollment · public domain (ClinicalTrials.gov) · T1
Enrollment: 80 participants (estimated).