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RO7293583 · 1 trial · 3 indications
Dose-Limiting Toxicities (DLTs) were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), except for Cytokine release syndrome (CRS), which will be graded based on the American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
| Arm | Type | Description |
|---|---|---|
| Part I: Single Participant Cohorts (IV) | EXPERIMENTAL | Part I is a dose escalation in single participant cohorts. RO7293583 will be administered intravenously (IV) every three weeks (Q3W). The starting dose will be 0.045mg and the maximum dose explored will be 1.5mg. |
| Part II: Multiple Participant Cohorts (IV/SC) | EXPERIMENTAL | Multiple ascending dose-escalation of RO7293583 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation will be determined by Part I and RO7293583 will be administered IV or SC every 3 weeks. Dose-escalation will be undertaken based on safety until determination of the MTD or the highest safe dose if MTD is not reached. Fractionated, step up or subcutaneous dosing may be implemented. The maximum dose explored will be 600mg IV and 160mg SC. |
| Name | Type | Description |
|---|---|---|
| RO7293583 | DRUG | RO7293583 will be administered at a dose and per schedule as specified for the respective cohort. |
| Tocilizumab | DRUG | Tocilizumab will be administered as required for the management of severe cytokine release syndrome (CRS). |
| Obinutuzumab | DRUG | If implemented, it will be given either on D-7 or D-7 and D-6. |
| Adalimumab | DRUG | If implemented, it will be given as a single dose approximately 6 days prior to the first dose of RO7293583. |
Inclusion Criteria: * Participants with unresectable stage III or stage IV cutaneous melanoma or participants with unresectable, metastatic uveal or mucosal melanoma for whom SOC is not available or who are intolerant or non-amenable to SOC. * Participants with cutaneous melanoma need to have known...
RO7293583 is an investigational small molecule being studied for the treatment of unresectable metastatic TYRP1-positive melanomas, including cutaneous melanoma. It is currently in Phase 1 clinical development and is not approved by regulatory authorities.
RO7293583 targets tyrosinase related protein 1 (TYRP1), a protein expressed on melanoma cells. By binding to TYRP1, the drug is designed to interfere with the growth and survival of TYRP1-positive melanoma cells.
RO7293583 is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded on the OTC market under the ticker symbol RHHBY.
RO7293583 is in Phase 1 clinical development. A Phase 1 study has been completed, and the drug remains investigational, meaning it has not yet received regulatory approval for any indication.
RO7293583 has been studied in one clinical trial, identified as NCT04551352. This Phase 1 study enrolled 20 participants with unresectable metastatic TYRP1-positive melanomas, including cutaneous, uveal, and mucosal melanoma, and was conducted in the United States, Australia, Belgium, Canada, Denmark, and Spain.