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RO7623066 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| RO7623066 Monotherapy (Dose Escalation) | EXPERIMENTAL | RO7623066 will be administered orally once daily (QD) continuously as monotherapy. Once the maximum tolerated dose (MTD) for RO7623066 monotherapy has been reached this concludes the Dose Escalation phase. |
| RO7623066 + Olaparib (Dose Escalation and Expansion) | EXPERIMENTAL | RO7623066 will be tested in combination with olaparib. Escalating dose levels will be tested until the maximum tolerated dose (MTD), or lower, of RO7623066 is reached or MTD, or lower, of the combination is reached (whichever occurs first). Combination arms can enroll concurrently. Olaparib will be dosed per standard of care (SoC). |
| RO7623066 + Carboplatin (Dose Escalation and Expansion) | EXPERIMENTAL | RO7623066 will be tested in combination with carboplatin. Escalating dose levels will be tested until the maximum tolerated dose (MTD), or lower, of RO7623066 is reached or MTD, or lower, of the combination is reached (whichever occurs first). Combination arms can enroll concurrently. Carboplatin will be dosed per standard of care (SoC). |
| RO7623066 + Olaparib Backfill Cohort | OTHER | Once safety data has been obtained in the RO7623066 + Olaparib arm during the dose escalation phase, Backfill cohorts will be used to determine the Recommended Dose for Expansion of RO7623066 + Olaparib. |
| RO7623066 Food Effect Cohort | OTHER | The effect of food intake on the PK of RO7623066 will be explored at a dose close to the Maximum Tolerated Dose (MTD) and/or at Recommended Phase II Dose (RP2D) or at a relevant dose level for a minimum of 12 participants that have at least one tumor mutation of interest. |
| Name | Type | Description |
|---|---|---|
| RO7623066 | DRUG | Administered orally in capsule |
| Olaparib | DRUG | Administered orally. Dose levels and schedules will be selected based on integration of preclinical data as well as clinical PK, safety, efficacy, and PD/biomarker data (as appropriate) from the dose escalation cohorts. |
| Carboplatin | DRUG | Administered intravenously. |
Inclusion Criteria: 1. Age 18 years or older 2. Life expectancy of ≥ 12 weeks 3. Measurable disease or non-measurable disease per RECIST v1.1 in dose escalation and the Food Effect Cohort only; patients in dose expansion and Backfill Cohorts are required to have measurable disease per RECIST v1.1 4...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
RO7623066 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development, meaning it has not yet been approved for any use. The drug is being evaluated in patients with advanced solid tumors to assess its safety and potential efficacy.
RO7623066 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced solid tumors. As of now, RO7623066 is in Phase 1 development.
RO7623066 is in Phase 1 clinical development. It is an investigational drug, meaning it is not yet approved by regulatory authorities. The drug is being studied in a Phase 1 trial for advanced solid tumors, and the trial has been completed.
RO7623066 has been studied in a Phase 1 clinical trial with the identifier NCT05240898. The trial, titled 'A Phase 1 Study of RO7623066 Alone and in Combination in Patients With Advanced Solid Tumors,' enrolled 116 participants in the United States. The study has been completed.
RO7623066 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug is being studied for the treatment of advanced solid tumors, but it has not yet received approval from the FDA or any other regulatory authority.