Phase 1/2Completed
Study of RP-3500, Camonsertib, in Advanced Solid Tumors (TRESR)
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)
- Sponsor
- Repare Therapeutics (Industry)
- Enrollment
- 276 enrolled
- Conditions
- Advanced Solid Tumor
- Interventions
- RP-3500 (camonsertib); Talazoparib; Gemcitabine Injection
- Ages
- adults, older adults
- Registry
- NCT04497116, EUCTR2020-000301-87
Full record on ClinicalTrials.gov
From the registry
The primary purpose of this study is to define the maximum tolerated dose (MTD) and determine a recommended Phase 2 dose (RP2D) and schedule of orally-administered RP-3500 (camonsertib) alone or in combination with talazoparib, a PARP inhibitor, or Gemcitabine in patients with advanced solid tumors with ATR inhibitor-sensitizing mutations. This study will also evaluate the safety and tolerability of RP-3500 (camonsertib) alone or in combination with talazoparib or gemcitabine, examine both the pharmacokinetics (PK)and pharmacodynamics (PD)and investigate its anti-tumor activity in solid tumors.
Primary outcomes
- Frequency of Treatment-Related Adverse Event of CTCAE Grade 3 and Above
- Frequency of Dose Limiting Toxicity (DLT)
History
Results first posted
Last registry update
Primary completion
Registered
Started