Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06128551 | Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors | PHASE1 | RECRUITING | 534 | — | — | Nov 14, 2023 | Jun 1, 2029 | Apr 23, 2026 | 53 | United States, France +5 |
Incidence and severity of treatment-emergent AEs and serious AEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5
Number of patients with clinically significant changes in vital signs
Number of patients with clinically significant changes in clinical laboratory test values
Number of participants with dose limiting toxicities
Number of patients with clinically significant changes in ECGs
Overall response rate per RECIST v1.1 as assessed by blinded independent central review (BICR)
| Arm | Type | Description |
|---|---|---|
| Elironrasib Monotherapy | EXPERIMENTAL | Phase 2 only |
| Daraxonrasib Monotherapy | EXPERIMENTAL | Phase 2 only |
| Daraxonrasib + Elironrasib Combination | EXPERIMENTAL | Phase 1b and 2 |
| Name | Type | Description |
|---|---|---|
| Elironrasib | DRUG | oral tablets |
| Daraxonrasib | DRUG | oral tablets |
Inclusion Criteria: * 18 years of age * Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic solid tumors not amendable to curative therapy 1. Phase 1b Dose Escalation: solid tumors, previously treated 2. Phase 1b Dose Expansion and Phase 2: i. NSCLC, previously t...