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GDC-6036 · 1 trial · 3 indications
Severity is determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
| Arm | Type | Description |
|---|---|---|
| Arm A: Dose-escalation (Stage I), Dose Expansion (Stage II) | EXPERIMENTAL | Participants in Stage I will receive GDC-6036 administered orally once daily (PO QD). The dose will be increased in successive cohorts until a study-specific threshold is reached. Participants with select solid tumors will be treated with GDC-6036 PO QD in Stage II. |
| Arm B: GDC-6036 + Atezolizumab (Stage I and Stage II) | EXPERIMENTAL | Participants with non-small cell lung cancer will receive GDC-6036 in combination with atezolizumab. |
| Arm C: GDC-6036 + Cetuximab (Stage I and Stage II) | EXPERIMENTAL | Participants with colorectal cancer will receive GDC-6036 in combination with cetuximab. |
| Arm D: GDC-6036 + Bevacizumab (Stage I and Stage II) | EXPERIMENTAL | Participants with solid tumors will receive GDC-6036 in combination with bevacizumab. |
| Arm E: GDC-6036 + Erlotinib (Stage I and Stage II) | EXPERIMENTAL | Participants with non-small cell lung cancer will receive GDC-6036 in combination with erlotinib. |
| Arm F: GDC-6036 + GDC-1971 (Stage I and Stage II) | EXPERIMENTAL | Participants with solid tumors will receive GDC-6036 in combination with GDC-1971 PO in Stage I. Participants with select solid tumors will be treated with GDC-6036 in combination with GDC-1971 PO in Stage II. |
| Arm G: GDC-6036 + Inavolisib (Stage I and Stage II) | EXPERIMENTAL | Participants with solid tumors will receive GDC-6036 in combination with inavolisib PO in Stage I. Participants with select solid tumors will be treated with GDC-6036 in combination with inavolisib PO in Stage II. |
| Name | Type | Description |
|---|---|---|
| GDC-6036 | DRUG | The starting dose of GDC-6036 in the combination Arms B, C, D, E, F and G will be determined from Stage I Arm A (single-agent dose escalation). |
| Atezolizumab | DRUG | A 1200 milligram (mg) intravenous (IV) infusion of atezolizumab will be administered on Day 1 of 21 day cycles. |
| Cetuximab | DRUG | Cetuximab will be administered at an initial dose of 400 milligram per square meter (mg/m\^2) IV infusion followed by 250 mg/m\^2 IV infusion weekly in 21 day cycles. |
| Bevacizumab | DRUG | A 15 milligram per kilogram (mg/kg) IV infusion of bevacizumab will be administered on Day 1 of 21 day cycles. |
| Erlotinib | DRUG | 150 mg of erlotinib will be administered PO QD in 21 day cycles. |
| GDC-1971 | DRUG | The starting dose of GDC-1971 will be determined from its single-agent dose escalation. |
| Inavolisib | DRUG | The starting dose of inavolisib will be determined from its single-agent dose escalation. |
Inclusion Criteria: * Histologically documented advanced or metastatic solid tumor with KRAS G12C mutation. * Women of childbearing potential must agree to remain abstinent or use contraception, and agree to refrain from donating eggs during the treatment period and after the final dose of study tr...
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GDC-6036 is an investigational small molecule being studied for the treatment of Non-Small Cell Lung Cancer, as well as Colorectal Cancer and other Advanced Solid Tumors. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
GDC-6036 targets cancers with a KRAS G12C mutation. It is being evaluated in participants with advanced or metastatic solid tumors that carry this specific genetic alteration, including Non-Small Cell Lung Cancer and Colorectal Cancer.
GDC-6036 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the safety, pharmacokinetics, and activity of the drug in patients with KRAS G12C-mutated tumors.
GDC-6036 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is active but not recruiting participants.
GDC-6036 is being studied in a single Phase 1 clinical trial with the identifier NCT04449874. This trial evaluates the drug alone or in combination in participants with advanced or metastatic solid tumors with a KRAS G12C mutation, enrolling approximately 498 patients across multiple countries.
GDC-6036 is a distinct investigational drug targeting the KRAS G12C mutation. It is being developed by Roche and is currently in Phase 1 trials. No alternative names for GDC-6036 have been disclosed in the available clinical trial information.