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RO7496353 · 1 trial · 3 indications
AEs will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).
| Arm | Type | Description |
|---|---|---|
| Cohort A: NSCLC | EXPERIMENTAL | Participants with NSCLC will receive RO7496353, and atezolizumab, given as an intravenous (IV) infusion at an assigned dose on Day 1 of each 21-day cycle until unacceptable toxicity or symptomatic deterioration attributed to disease progression (PD). |
| Cohort B: GC | EXPERIMENTAL | Participants with GC will receive RO7496353, nivolumab, and oxaliplatin, given as an IV infusion at an assigned dose on Day 1 of each 21-day cycle along with either capecitabine or S-1, orally, twice daily on Days 1 to 14 of each cycle until unacceptable toxicity or symptomatic deterioration attributed to PD. |
| Cohort C: PDAC | EXPERIMENTAL | Participants with PDAC will receive RO7496353, and atezolizumab, given as an IV infusion at an assigned dose on Days 1 and 15 of each 28-day cycle along with nab-paclitaxel, and gemcitabine, also given as an IV infusion on Days 1, 8, 15 of each 28-day cycle until unacceptable toxicity or symptomatic deterioration attributed to PD. |
| Substudy: UC | EXPERIMENTAL | Participants with UC will receive RO7496353, and atezolizumab, given as an IV infusion at an assigned dose on Day 1 of each 21-day cycle until unacceptable toxicity or symptomatic deterioration attributed to PD. |
| Name | Type | Description |
|---|---|---|
| RO7496353 | DRUG | RO7496353 will be administered as per the schedules specified in the respective arms. |
| Atezolizumab | DRUG | Atezolizumab will be administered as per the schedules specified in the respective arms. |
| Capecitabine | DRUG | Capecitabine will be administered as per the schedule specified in the respective arm. |
| S-1 | DRUG | S-1 will be administered as per the schedule specified in the respective arm. |
| Nivolumab | DRUG | Nivolumab will be administered as per the schedule specified in the respective arm. |
| Oxaliplatin | DRUG | Oxaliplatin will be administered as per the schedule specified in the respective arm. |
| Nab-paclitaxel | DRUG | Nab-paclitaxel will be administered as per the schedule specified in the respective arm. |
| Gemcitabine | DRUG | Gemcitabine will be administered as per the schedule specified in the respective arm. |
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy of at least 3 months * Adequate hematologic and end-organ function * Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy * Measurable disea...
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RO7496353 is an investigational small molecule being studied for the treatment of non-small cell lung cancer, as well as gastric cancer and pancreatic ductal adenocarcinoma. It is being evaluated in combination with a checkpoint inhibitor, with or without standard-of-care chemotherapy, in patients with locally advanced or metastatic solid tumors.
RO7496353 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this investigational small molecule for oncology indications.
RO7496353 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety, pharmacokinetics, and activity in clinical trials.
RO7496353 is being studied in clinical trial NCT05867121, a Phase 1 study evaluating its safety, pharmacokinetics, and activity in combination with a checkpoint inhibitor, with or without standard-of-care chemotherapy, in patients with locally advanced or metastatic solid tumors. The trial has been completed.
RO7496353 is also known by the study identifier GO44010, as referenced in the clinical trial title. This identifier is used to associate the drug with its specific clinical study program.