RASolute 302: A Phase 3 Multicenter, Open-label, Randomized Study of RMC-6236 versus Investigator's Choice of Standard of Care Therapy in Patients with Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

Objective:

Primary Objectives:

• In the RAS G12-mutant population (referred to as RAS G12 population): To compare the effect of treatment with RMC-6236 versus Investigator’s choice of standard therapy on:
  • ­PFS­
  • OS

Secondary Objectives:

• In the All-Patient population: To compare the effect of treatment with RMC-6236 versus Investigator’s choice of standard therapy on:
  • PFS
  • OS
• In the RAS G12 and All-Patient populations: To compare the effect of treatment with RMC-6236 versus Investigator’s choice of standard therapy on objective response.
• In the RAS G12 and All-Patient populations: To compare the effect of treatment with RMC-6236 versus Investigator’s choice of standard therapy on quality of life (QoL), as reported by patients, using EORTC QLQ-PAN26 and EORTC QLQ-C30.
• In the RAS G12 and All-Patient populations: To compare the effect of treatment with RMC-6236 versus Investigator’s choice of standard therapy on: − Objective Response (per investigator)
  • DOR
  • TTR
• In the RAS G12 and All-Patient populations: To compare the effect of treatment with RMC-6236 versus Investigator’s choice of standard therapy on quality of life (QoL), as reported by patients, using the EORTC QLQ-C30 and EORTC QLQPAN26.
• In the RAS G12 and All-Patient populations: To compare the effect of treatment with RMC-6236 versus Investigator’s choice of standard therapy on PFS as assessed by the Investigator.
• In the RAS G12 and All-Patient populations: To compare the safety and tolerability of RMC-6236 versus Investigator’s choice of standard therapy.
• In the RAS G12 and All-Patient populations: To characterize the PK of RMC-6236.