TRESR study
Research type
Research Study
Full title
Phase 1/2a Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of RP-3500 Alone or in Combination with Talazoparib or Gemcitabine in Advanced Solid Tumors with ATR inhibitor Sensitizing Mutations (TRESR Study)
IRAS ID
286609
Contact name
Ruth Plummer
Contact email
Sponsor organisation
Repare Therapeutics, Inc
Eudract number
2020-000301-87
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
146,280, IND number
Duration of Study in the UK
4 years, 2 months, 0 days
Research summary
This is an exploratory, modular, Phase 1/2a, first-in-human, multicenter, open-label, non-randomized, dose escalation, and dose-expansion study of RP-3500 administered orally as a single agent or in combination with talazoparib or gemcitabine in patients with advanced solid tumors.
RP-3500 is a highly potent and selective ATRi as demonstrated in biochemical and cell-based assays. RP-3500 is predicted to have a suitable pharmacokinetic (PK) profile in humans and demonstrates efficacy in several xenograft models of cancer as a single agent.
Patients will be enrolled based on center-specific routine genomic and immunohistochemistry (IHC) tests able to detect alterations in genes associated with ATRi sensitivity. In Modules 1 through 4, approximately 451 patients are expected to be enrolled at approximately 20 sites globally. As of Protocol Amendment 6.0, Module 5 (originally planned for 20 patients) is closed to accrual per Sponsor decision; no patients were enrolled in this module.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
20/NE/0270
Date of REC Opinion
22 Dec 2020
REC opinion
Further Information Favourable Opinion