Clinical trial · Interventional
JAB-23E73 in Adult Participants With Advanced Solid Tumors With KRAS Alteration
A Phase 1/2a, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of JAB-23E73 in Adult Patients With Advanced Solid Tumors With KRAS Alteration
NCT06973564CI-TRIAL-00101075recruitingPhase 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)
This study is to evaluate the safety and tolerability of pan-KRAS inhibitor JAB-23E73 in adult participants with advanced solid tumors
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 Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JAB-23E73 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Dose Escalation (Phase 1a)
- description
- Evaluate overall Safety, tolerability, and determine MTD of JAB-23E73 monotherapy.
- interventionNames
- Drug: JAB-23E73
- type
- EXPERIMENTAL
- label
- Dose Expansion / Optimization Phase (Phase 1b)
- description
- Determine RP2D of JAB-23E73 in patients with KRAS-alternated NSCLC or other selected tumors
- interventionNames
- Drug: JAB-23E73
- type
- EXPERIMENTAL
- label
- Indication Expansion (Phase 2a)
- description
- Evaluate the preliminary antitumor activity of JAB-23E73 monotherapy at the RP2D in patients with advanced or metastatic CRC, PDAC, and other solid tumors.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent. * Participant must be ≥18 years of age at the time of signing the Informed Consent Form (ICF). * Histologically or cytologically confirmed locally advanced or metastatic solid tumors that are not suitable for curative interventions. * Patients must have KRAS alterations. * Participants are required to provide an archived tumor sample. * Patients with a life expectancy ≥3 months. * ECOG performance status score of 0 or 1. * Patients must have at least one measurable lesion as defined by RECIST v1.1. Exclusion Criteria: * Inability to swallow oral medications, or presence of gastrointestinal dysfunction or gastrointestinal disorders that may significantly alter the absorption of the study drug. * Patients who have previously been treated with KRAS G12C inhibitors, KRAS G12D inhibitors, or pan/multi-KRAS inhibitors. * Known serious allergy to JAB-23E73 or excipient. * Patients with primary central nervous system tumors. * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures or medical intervention. * QT interval\>470 msec. * LVEF ≤50% assessed by ECHO or MUGA.
References
Publications (0)
Data not yet available
No reference posted for this study.