Clinical trial · Interventional
A Phase I/IIa Study of JAB-23E73 in Patients With Advanced Solid Tumors Harboring KRAS Gene Alteration
A Multicenter, Open Phase I/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of JAB-23E73 in Patients With Advanced Solid Tumors Harboring KRAS Gene Alteration
- 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)
This is a multicenter, open-label, phase I/IIa to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of pan-KRAS inhibitor JAB-23E73 in patients with advanced solid tumors harboring KRAS mutations or amplification. The study consists of 2 phases: Phase 1 Dose Escalation and Phase IIa Dose Expansion.
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 |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JAB-23E73 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase 1 Dose Exploration
- description
- Monotherapy, dose escalation
- interventionNames
- Drug: JAB-23E73
- type
- EXPERIMENTAL
- label
- Phase 2a Dose Expansion
- description
- Monotherapy, dose expansion
- interventionNames
- Drug: JAB-23E73
Primary outcomes (2)
- measure
- Phase 1: Number of participants with dose limiting toxicities (DLT)
- timeFrame
- Up to 21 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Histological or cytologically proven diagnosis of a locally advanced, unresectable, and/or metastatic solid tumor cancer with evidence of KRAS gene alteration (including gene mutation and wild type amplification). 2. Able to provide an archived tumor tissue sample or fresh biopsy sample. 3. Life expectancy ≥3 months at the start of treatment. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. ≥1 measurable lesion per RECIST v1.1. 6. Adequate organ function. Exclusion Criteria: 1. Unable to swallow oral medications or with gastrointestinal dysfunction or gastrointestinal disease that significantly alters the absorption of medication. 2. Previous treatment with rat sarcoma (RAS) targeting agents. 3. Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases. 4. Impaired cardiovascular function or clinically significant cardiac disease. 5. Mean QT interval corrected using Fridericia's formula (QTcF) \>470 msec. 6. Females who are pregnant or breastfeeding.
References
Publications (0)
Data not yet available