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RO7616789 · 1 trial · 2 indications
Adverse events were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), and Cytokine release syndrome (CRS), will be graded based on the American Society for Transplantation and Cell Therapy (ASTCT) criteria.
| Arm | Type | Description |
|---|---|---|
| Part 1: RO7616789 QW: Dose Escalation | EXPERIMENTAL | Participants will receive a fixed dose of RO7616789 intravenously once weekly (QW) per dose level on Day 1, 8, and 15 of each 21-day cycle. In case of toxicity, step-up (single or double) dosing may be explored. |
| Part 2: RO7616789 Q3W: Dose Escalation | EXPERIMENTAL | Participants will receive a fixed dose of RO7616789, at a dose determined in Part 1, intravenously once every 3 weeks (Q3W) on Day 1 of each 21-day cycle. In case of toxicity, step-up (single or double) dosing may be explored. |
| Part 3: Dose Expansion | EXPERIMENTAL | Based on emerging data from Part 1 and 2, one or more dosing regimens will be further investigated in Part 3. |
| Name | Type | Description |
|---|---|---|
| RO7616789 | DRUG | RO7616789 solution for infusion will be administered intravenously at a dose and per schedule as specified for the respective part. |
| Tocilizumab | DRUG | Tocilizumab will be used as rescue therapy, in case of clinical presentation of cytokine release syndrome (CRS). Tocilizumab solution for infusion will be administered intravenously at 8 mg/kg for participants \>/= 30 kg or at 12 mg/kg for participants \< 30 kg. |
Inclusion Criteria: * Life expectancy at least 12 weeks * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate hematologic and end organ function * Negative serum pregnancy test. * Adequate contraception and no or interruption of breastfeeding * Histologically confirmed...
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RO7616789 is an investigational small molecule being studied for the treatment of advanced small cell lung cancer and other neuroendocrine carcinomas. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
The molecular target of RO7616789 has not been disclosed in available information. It is being evaluated for its safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity in patients with advanced small cell lung cancer and other neuroendocrine carcinomas.
RO7616789 is being developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's safety and preliminary efficacy in oncology indications.
RO7616789 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. The drug is being studied for safety, tolerability, and preliminary anti-tumor activity in advanced small cell lung cancer and neuroendocrine carcinomas.
RO7616789 has been studied in one completed Phase 1 clinical trial, NCT05619744. This trial evaluated the drug in 41 patients with advanced small cell lung cancer and neuroendocrine carcinomas across the United States, Denmark, Japan, Poland, and Spain.