Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO7051790 · 1 trial · 1 indication
DLTs were to be assessed based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03. DLTs were at least possibly related to RO7051790 and had to meet any one of the following criteria: Grade≥4 neutropenia lasting \>7 days; Grade 4 thrombocytopenia; Grade 3 thrombocytopenia with bleeding; Grade≥4 anemia; Febrile neutropenia; Grade≥3 elevation in serum hepatic transaminase lasting \>7 days; Grade≥3 elevation of serum bilirubin; and Grade≥3 non-hematologic, non-hepatic adverse event (with few exceptions).
| Arm | Type | Description |
|---|---|---|
| Introductory Cohort - 400 μg RO7051790 | EXPERIMENTAL | Introductory cohort to ensure participant safety, prior to the dose escalation study. 400 μg of RO7051790 was administered to two (2) participants followed by a 21-day DLT observation period. |
| Dose Escalation - 1000 μg RO7051790 | EXPERIMENTAL | 1000 μg of RO7051790 was administered to six (6) participants once every 3 weeks (Q3W). |
| Dose Escalation - 1300 μg RO7051790 | EXPERIMENTAL | 1300 μg of RO7051790 was administered to seven (7) participants once every 3 weeks (Q3W). |
| Dose Escalation - 1900 μg RO7051790 | EXPERIMENTAL | 1900 μg of RO7051790 was administered to three (3) participants once every 3 weeks (Q3W). |
| Name | Type | Description |
|---|---|---|
| RO7051790 | DRUG | RO7051790 will be given orally. Treatment will be continued until disease progression/treatment failure, unacceptable toxicity, or study discontinuation. |
Inclusion Criteria: * Life expectancy greater than or equal to (\>=) 12 weeks * Participants must have histologically or cytologically confirmed diagnosis of SCLC * Participants must have recurrent or refractory disease after receiving at least one prior platinum-containing chemotherapy regimen, or...
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RO7051790 is an investigational small molecule being studied for the treatment of relapsed, extensive-stage disease small cell lung cancer (ED SCLC). It is administered orally and is currently in Phase 1 clinical development for this indication.
RO7051790 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 small cell lung cancer.
RO7051790 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study has been completed to assess its safety and tolerability in patients with relapsed extensive-stage small cell lung cancer.
RO7051790 has one completed clinical trial, NCT02913443, titled 'A Dose Finding and Expansion Study of RO7051790 Administered Orally in Participants With Relapsed, Extensive-Stage Disease Small Cell Lung Cancer (ED SCLC)'. This Phase 1 study enrolled 18 participants across the United States, Canada, Denmark, France, and Spain.
RO7051790 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for small cell lung cancer. The drug has not yet completed the clinical trials required to seek regulatory approval.