Study of RP-3500, Camonsertib, in Advanced Solid Tumors

Summary

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.

Timeline

Start

2020-07-22

Primary completion

2025-06-13

Completion

2025-06-13

Publications

• Fontana E, Rosen E, Lee EK, Hojgaard M, Mettu NB, Lheureux S, Carneiro BA, Cote GM, Carter L, Plummer R, Mahalingam D, Fretland AJ, Schonhoft JD, Silverman IM, Wainszelbaum M, Xu Y, Ulanet D, Koehler M, Yap TA. Ataxia telangiectasia and Rad3-related (ATR) inhibitor camonsertib dose optimization in patients with biomarker-selected advanced solid tumors (TRESR study). J Natl Cancer Inst. 2024 Sep 1;116(9):1439-1449. doi: 10.1093/jnci/djae098.
• Yap TA, Fontana E, Lee EK, Spigel DR, Hojgaard M, Lheureux S, Mettu NB, Carneiro BA, Carter L, Plummer R, Cote GM, Meric-Bernstam F, O'Connell J, Schonhoft JD, Wainszelbaum M, Fretland AJ, Manley P, Xu Y, Ulanet D, Rimkunas V, Zinda M, Koehler M, Silverman IM, Reis-Filho JS, Rosen E. Camonsertib in DNA damage response-deficient advanced solid tumors: phase 1 trial results. Nat Med. 2023 Jun;29(6):1400-1411. doi: 10.1038/s41591-023-02399-0. Epub 2023 Jun 5.

Drugs

Indications