Clinical trial · Interventional
Study of JAB-23E73 in Combination With Chemotherapy in Participants With Metastatic PDAC Harboring KRAS Gene Alterations
A Multicenter, Phase Ib/III Study to Evaluate JAB-23E73 in Combination With Nab-Paclitaxel and Gemcitabine in Participants With Metastatic Pancreatic Ductal Adenocarcinoma Harboring KRAS Gene Alterations
NCT07640295CI-TRIAL-00124205recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JAB-23E73 tablet,nab-paclitaxel,gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose escalation/backfill
- interventionNames
- Drug: JAB-23E73 tablet,nab-paclitaxel,gemcitabine
Primary outcomes (2)
- measure
- Dose limiting toxicities (DLT)
- timeFrame
- Up to 28 days
- description
- The number and proportion of participants who experienced dose-limiting toxicities (DLT).
- measure
- Adverse events.safety evaluation
- timeFrame
- Up to approximately 3 years
- description
- 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.
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.