Study of RP-6306 Alone or in Combination With RP-3500 in Patients With Advanced Solid Tumours

Official Title

Phase 1 Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of RP-6306 Alone or in Combination With RP-3500 in Patients With Advanced Solid Tumours

Summary:

The primary purpose of this study is to assess the safety and tolerability of RP-6306 alone and in combination with RP-3500 in patients with eligible advanced solid tumours, determine the maximum tolerated dose (MTD) and assess preliminary anti-tumour activity.

Trial Description

Primary Outcome:

• Safety and Tolerability of RP-6306 in patients with advanced solid tumours as assessed by NCI CTCAE v5.0
• To define the MTD of RP-6306 monotherapy, and determine a recommended Phase 2 dose (RP2D) and preferred schedule
• Safety and Tolerability of RP-6306 in combination with RP-3500 in patients with advanced solid tumours as assessed by NCI CTCAE v5.0
• To define the MTD of RP-6306 in combination with RP-3500, and determine a recommended Phase 2 dose (RP2D) and preferred schedule

Secondary Outcome:

• To assess the plasma concentrations of RP-6306 monotherapy in the fasted and fed states.
• To assess the correlation between RP-6306 dose (mg) and degree of inhibition of phospho-CDK1 signal by immunohistochemistry.
• To assess the percent of patients with a response to RP-6306 monotherapy per RECIST v1.1 criteria.
• To assess the correlation between RP-6306 and RP-3500 dose (mg) and degree of gamma-H2AX induction by immunohistochemistry.
• To assess the percent of patients with a response to RP-6306 and RP-3500 per RECIST v1.1 criteria.

Phase 1, multi-centre, open-label, dose-escalation study to: Evaluate the safety profile and MTD of RP-6306 alone and in combination with RP-3500 when administered orally to establish the recommended Phase 2 dose and schedule Characterize the PK and pharmacodynamics of RP-6306 alone and in combination with RP-3500 Assess preliminary anti-tumour activity associated with RP-6306 alone and in combination with RP-3500

View this trial on ClinicalTrials.gov