Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as RP-3500 (camonsertib)
RP-3500 · 2 trials · 3 indications
by assessing the grade and frequency of adverse events and serious adverse events. A dose limiting toxicity (DLT) will be graded according to NCI CTCAE v5.0.
Imaging per discretion of treating physician, and may include PET, CT and MRI imaging.
Treatment-emergent adverse events (TEAEs) are those events that occur or worsen on or after the first dose of study drug up through 30 days post the last dose (or cross over to a different module) or the start of subsequent anticancer therapy. AEs are considered related to treatment if the relationship to camonsertib or the other combination drug (in the study regimen) is "Related" (include unknown relationship) as indicated on the AE eCRF page based on investigator's assessment.
Toxicity were assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. A toxicity was considered dose-limiting if it occurred during the first cycle and was deemed at least possibly related to study treatment. If multiple toxicities occurred, the most severe toxicity was used in the assessment. The DLT Evaluable population consists of patients who received at least 80% of planned total doses of camonsertib , 80% of planned total doses of camonsertib and talazoparib, or 80% of planned total doses of camonsertib and 100% of gemcitabine; complete all required safety evaluations and are observed through the end of Cycle 1; or patients who experience a DLT qualifying event in the first cycle of treatment.
| Arm | Type | Description |
|---|---|---|
| RP-3500 in Combination With Standard Radiation Therapy | EXPERIMENTAL | Patients with metastatic cancers with identified mutations in ATM will be enrolled. All patients will receive a standard palliative RT (4Gy x 5 fractions) on Days 1-5 in combination with RP-3500 on Days 1-5. In the first phase of the study, a 3+3 study design will be used to identify a safe dose of RP-3500 (starting at 80 mg QD) in combination with palliative RT. |
| Pilot subcohort | EXPERIMENTAL | The primary objective is to assess 6 month local control rate of patients of new metastatic lesions with pathogenic ATM who haves received prior RP-3500 and palliative RT. |
| RP-3500 (camonsertib) alone | EXPERIMENTAL | Phase 1: Multiple doses of RP-3500 (camonsertib) for oral administration alone |
| Expansion cohorts with RP-3500 (camonsertib) | EXPERIMENTAL | Phase 2: Expansion cohorts with RP-3500 (camonsertib) |
| RP-3500 (camonsertib) with Talazoparib or Gemcitabine | EXPERIMENTAL | Phase 1: Multiple doses of RP-3500 (camonsertib) for oral administration in combination with talazoparib or gemcitabine |
| Name | Type | Description |
|---|---|---|
| RP-3500 | DRUG | RP-3500 on Days 1-5. |
| External Beam Radiotherapy (EBRT) | RADIATION | Palliative radiation therapy (4Gy x 5 fractions) to a metastatic site on Days 1-5 |
| RP-3500 (camonsertib) | DRUG | Oral ATR inhibitor |
| Talazoparib | DRUG | Oral PARP inhibitor |
| Gemcitabine Injection | DRUG | Gemcitabine |
Inclusion Criteria: * Histologically confirmed malignancy with at least one metastatic lesion amenable to radiotherapy. Bone, visceral, and soft tissue are eligible. * Mutation in ATM (deleterious or VUS; somatic or germline; monoallelic or biallelic) * Note: Homozygous Deletion in the ATM gene ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
RP-3500 is an investigational small molecule being studied in adults with advanced solid tumors and metastatic cancer. It is being evaluated both as a single agent and in combination with standard radiation therapy. It is not approved for any indication and remains in clinical development.
RP-3500 targets ATR, a protein kinase involved in the DNA damage response. By inhibiting ATR, the drug is designed to interfere with cancer cell DNA repair pathways. This mechanism is being explored in advanced solid tumors, including in combination with radiation therapy.
RP-3500 is being developed by Repare Therapeutics Inc., a clinical-stage oncology company that trades under the ticker RPTX. Repare is the sponsor of the clinical program evaluating RP-3500 in advanced solid tumors and in combination with radiation therapy.
RP-3500 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority. The Phase 1 program includes a completed monotherapy study in advanced solid tumors and an active combination study with radiation therapy.
RP-3500 has been studied in NCT04497116, a completed Phase 1 trial of camonsertib in advanced solid tumors across the United States, Canada, Denmark, and the United Kingdom, which enrolled 276 patients. It is also being studied in NCT05566574, an active Phase 1 trial combining RP-3500 with standard radiation therapy in solid tumors and metastatic cancer in the United States, with 49 patients enrolled.
Yes. Camonsertib is the alternative name for RP-3500. The two names refer to the same investigational ATR inhibitor developed by Repare Therapeutics. Publications and trial records may use either name, including the trial title for NCT04497116, which refers to the agent as RP-3500, camonsertib.