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 Tumors

UVA Tracking #
HSR230401
Principal Investigator
Linda R Duska
Contact
Contact Phone
Official Trial 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 Tumors (MYTHIC Study)
Study Description

The University of Virginia seeks adults ages 18 and over with locally advanced or metastatic resistant or refractory solid tumors harboring either CCNE1 amplification or a deleterious mutation in either FBXW7 or PPP2R1A, or other mutation with mechanistic rationale.
The primary goals of this study are:
- To assess the safety and tolerability of RP-6306, a first in class membrane-associated tyrosine- and threonine-specific Cdc2-inhibitory kinase (PKMYT1) inhibitor with RP-3500, an ataxia telangiectasia-mutated - and rad3-related (ATR) inhibitor in people with advanced solid tumors
- To determine the maximum tolerated dose (MTD) of RP-6306 combined with RP-3500 and determine recommended doses and schedules
All eligible participants will receive both study drugs; RP-6306 and RP-3500. Participants will receive study treatment up to discontinuation. This trial will last for approximately 30 months, with a 28 day screening period, 24 month treatment period (treatment period may vary), a 30 day safety follow-up, and survival follow-up for up to 1 year.
This study involves blood sampling, tumor biopsies, and an electrocardiogram (ECG). The study drug will be taken by mouth and participants will be given instructions and a dosing diary for drug administration.
Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.

Compensation

$65 per study visit