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GDC-1971 · 2 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| Dose-Finding Stage: Non-Small Cell Lung Cancer (NSCLC) | EXPERIMENTAL | Participants with unresectable, locally advanced or metastatic NSCLC will receive GDC-1971 at an assigned dose, orally, once daily (QD), on Days 1 to 28 of each 28-day cycle in combination with osimertinib, 80 milligrams (mg), orally, QD, on Days 1 to 28 of each cycle until disease progression or unacceptable toxicity. |
| Dose-Finding Stage: Colorectal Cancer (CRC) | EXPERIMENTAL | Participants with metastatic CRC will receive GDC-1971, at an assigned dose, orally, QD, on Days 1 to 28 days of each 28-day cycle in combination with cetuximab, 500 milligrams per square meter (mg/m\^2), given by IV infusion on Days 1 and 15 of each cycle, until disease progression or unacceptable toxicity. |
| Dose Expansion Stage: NSCLC | EXPERIMENTAL | Participants with unresectable, locally advanced or metastatic NSCLC will receive GDC-1971 at a dose determined in the dose finding stage, orally, QD, on Days 1 to 28 of each 28-day cycle in combination with osimertinib, 80 mg, orally, QD, on Days 1 to 28 of each cycle until disease progression or unacceptable toxicity. |
| Dose Expansion Stage: CRC | EXPERIMENTAL | Participants with metastatic CRC will receive GDC-1971 at a dose determined in the dose finding stage, orally, QD, on Days 1 to 28 of each 28-day cycle in combination with cetuximab, 500 mg/m\^2, given by IV infusion on Days 1 and 15 of each cycle until disease progression or unacceptable toxicity. |
| Dose-finding Stage: GDC-1971 | EXPERIMENTAL | Participants will receive GDC-1971 tablet or capsule at assigned dose, orally once daily (QD) on Days 1-21 of each cycle, along with atezolizumab 1200 milligrams (mg) intravenous (IV) infusion once every 3 weeks (Q3W), until unacceptable toxicity or loss of clinical benefit. A subset of participants will participate in evaluations regarding tablet versus (vs) capsule formulations. |
| Expansion Stage: GDC-1971 | EXPERIMENTAL | Participants will receive GDC-1971 orally at the assigned dose QD on Days 1-21 of each cycle and atezolizumab 1200 mg IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit. A subset of participants will participate in evaluations regarding tablet vs capsule formulation, the effect of food and acid-reducing agents on GDC-1971. |
| Name | Type | Description |
|---|---|---|
| GDC-1971 | DRUG | GDC-1971 capsules or tablets will be administered as specified in each treatment arm. |
| Osimertinib | DRUG | Osimertinib tablets will be administered as specified in each treatment arm. |
| Cetuximab | DRUG | Cetuximab, solution for infusion will be administered as specified in each treatment arm. |
| Atezolizumab | DRUG | Administered as IV infusion. |
| Omeprazole | DRUG | Administered orally as tablet or capsule in the acid-reducing agent assessment. |
Inclusion Criteria: * Evaluable or measurable disease per RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy of ≥12 weeks * Adequate hematologic and organ function within 14 days prior to initiation of study Inclusion Criteria for Non-Small Cell L...
| 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 |
GDC-1971 is an investigational small molecule being studied for the treatment of colorectal cancer and advanced solid tumors. It is being evaluated in combination with other cancer therapies, including atezolizumab, osimertinib, and cetuximab, in patients with locally advanced or metastatic disease.
GDC-1971 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The drug is currently in Phase 1 clinical development for oncology indications.
GDC-1971 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, with a total of 67 participants enrolled across both studies.
GDC-1971 has been studied in two completed Phase 1 trials. NCT05487235 evaluated GDC-1971 with atezolizumab in advanced or metastatic solid tumors, enrolling 57 participants. NCT05954871 evaluated GDC-1971 with osimertinib in non-small cell lung cancer or with cetuximab in metastatic colorectal cancer, enrolling 10 participants.
GDC-1971 is a small molecule, but its specific molecular target has not been disclosed in available information. It is being studied in combination with other cancer therapies to evaluate its safety, pharmacokinetics, and activity in patients with advanced solid tumors.