This is a FIH, ascending dose study to characterize the safety, tolerability, optimal dose and preliminary anti-tumor activity of IMM-6-415 in participants with advanced or metastatic solid tumors harboring RAS or RAF oncogenic mutations.
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Phase 1/2a: Adverse Events
Timeframe: From treatment initiation through 30 days following the last IMM-6-415 dose
Phase 1: Dose-Limiting Toxicities (DLT)
Timeframe: The first 21 days of study treatment
Phase 1: Recommended Phase 2 Dose (RP2D) candidate
Timeframe: Initiation of study treatment through 21 days (up to approximately 18 months)
Phase 1: Maximum Observed Plasma Concentration of IMM-6-415
Timeframe: After 9 weeks (3 Cycles) of study treatment
Phase 1: Time to Reach Maximum Observed Plasma Concentration of IMM-6-415
Timeframe: After 9 weeks (3 Cycles) of study treatment
Phase 1: Area Under Plasma Concentration (AUC) Time Curve of IMM-6-415
Timeframe: After 9 weeks (3 Cycles) of study treatment
Phase 1: Pharmacodynamic (PD) Activity of IMM-6-415 Plasma Concentrations Over Time
Timeframe: After 9 weeks (3 Cycles) of study treatment
Phase 2a: Overall Response Rate (ORR)
Timeframe: After up to 48 weeks (16 cycles) of study treatment