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RO5509554 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part 1 - Dose Escalation: RO5509554 | EXPERIMENTAL | Participants will receive a single, low dose of 100 milligrams (mg) RO5509554 in 7-day PK run-in period (Cycle 0), followed by dose escalation from Day 1 of Cycle 1. RO5509554 will be escalated as monotherapy in approximately 6 cohorts with dose increments between cohorts of up to 100 percent (%). The doses will be escalated further until MTD/OBD as single agent is reached. |
| Part 1 - Dose Escalation: RO5509554 + Paclitaxel | EXPERIMENTAL | RO5509554 will be administered in combination with a fixed dose of weekly (QW) paclitaxel (80 milligrams per square meter \[mg/m\^2\]). The starting dose for RO5509554 in combination with paclitaxel will be 2 dose levels below to that of the highest dose of monotherapy RO5509554. Escalation of RO5509554 in combination with QW paclitaxel will start in a standard 3 + 3 design until MTD/OBD as combination dose is reached. If the initial combination is not tolerated, further cohorts will be dosed with the same dose of paclitaxel and lower dose of RO5509554. If insufficient safety, pharmacokinetic or pharmacodynamic data have been collected at the MTD/OBD, up to an additional 4 participants may be enrolled at that dose level. |
| Part 2 - Expansion Cohort: RO5509554 | EXPERIMENTAL | Participants will receive RO5509554 1000 mg Q2W, Q3W or initial biweekly followed by monthly maintenance. |
| Part 2 - Expansion Cohort: RO5509554 + Paclitaxel | EXPERIMENTAL | Participants will receive RO5509554 1000 mg Q2W in combination with a fixed dose of QW paclitaxel (80 mg/m\^2). |
| Name | Type | Description |
|---|---|---|
| Paclitaxel | DRUG | Paclitaxel, at a dose of 80 mg/m\^2 will be administered QW for up to 12 weeks. |
| RO5509554 | DRUG | RO5509554 will be administered Q2W, Q3W or initial biweekly followed by monthly maintenance as intravenous (IV) infusion until disease progression, unacceptable toxicity, death or participant refusal, whichever occurs first. |
Inclusion Criteria: * Histologically confirmed advanced and/or metastatic solid tumors which are not amenable to standard therapy, with exceptions as defined in exclusion criteria * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Measurable disease according to RECIST criteria...
| 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 |
RO5509554 is an investigational small molecule being studied for the treatment of advanced solid tumors. It was evaluated in a Phase 1 clinical trial as a monotherapy and in combination with paclitaxel in participants with advanced solid tumors.
RO5509554 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company sponsored a Phase 1 clinical trial of the drug in participants with advanced solid tumors.
RO5509554 is in Phase 1 clinical development. A Phase 1 study of the drug, both as a monotherapy and in combination with paclitaxel, has been completed. It is an investigational agent and is not approved for any use.
RO5509554 has been studied in one clinical trial, NCT01494688, titled 'A Study of RO5509554 as Monotherapy and in Combination With Paclitaxel in Participants With Advanced Solid Tumors.' This Phase 1 trial enrolled 217 participants and was conducted in the United States and France.
RO5509554 is the primary name for this investigational small molecule. No alternative names have been reported for this drug in the available clinical trial information.