Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05566574 | A Study of RP-3500 in Combination With Standard Radiation Therapy in People With Solid Tumor Cancer | PHASE1 | ACTIVE NOT_RECRUITING | 49 | — | — | Sep 30, 2022 | Sep 30, 2026 | Dec 17, 2025 | 7 | United States |
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.
| 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. |
| 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 |
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 | 2 | PHASE2 | pembrolizumab, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |