This study is to evaluate the safety, tolerability, and PK profiles of Elironrasib and Daraxonrasib as monotherapies and combination therapy in patients with KRAS G12C-mutated solid tumors.
18 years of age
Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic solid tumors not amendable to curative therapy
Phase 1b Dose Escalation: solid tumors, previously treated
ECOG performance status 0 or 1
Primary central nervous system (CNS) tumors
Active brain metastases
Known impairment of GI function that would alter the absorption
Major surgical procedures within 28 days or non-study related minor procedures within 7 days of treatment
Sequential
Elironrasib
Drugoral tablets
Daraxonrasib
Drugoral tablets
Number of patients with adverse events (AEs) in Phase 1b
Incidence and severity of treatment-emergent AEs and serious AEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5
Changes in vital signs in Phase 1b
Number of patients with clinically significant changes in vital signs
Changes in clinical laboratory test values in Phase 1b
Number of patients with clinically significant changes in clinical laboratory test values
Dose Limiting Toxicities in Phase 1b
Number of participants with dose limiting toxicities
Maximum Observed Blood Concentration of Elironrasib and Daraxonrasib
Cmax
Time to Reach Maximum Blood Concentration of Elironrasib and Daraxonrasib
Tmax
Area Under Blood Concentration Time Curve of Elironrasib and Daraxonrasib
AUC
Elimination Half-Life of Elironrasib and Daraxonrasib
t1/2
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