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Also known as RLY-1971, RO7517834
GDC-1971 · 3 trials · 5 indications
MTD is defined as a dose level immediately below that at which ≥2 of 6 subjects experience a DLT during the first cycle.
RP2D may be the same dose level or lower than the determined MTD.
| 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. |
| RLY-1971 - Dose Escalation/Expansion | EXPERIMENTAL | Dose Escalation: Oral dose of RLY-1971 until Maximum Tolerated Dose (MTD), and Recommended Phase 2 dose (RP2D) are identified Dose Expansion: Oral dose of RLY-1971 once Maximum Tolerated Dose (MTD), and Recommended Phase 2 Dose (RP2D) are identified. |
| 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. |
| RLY-1971 | DRUG | RLY-1971 is an oral inhibitor of SHP2. |
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 | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
GDC-1971 is an investigational small molecule being developed by Roche Holding AG for the treatment of advanced solid tumors and colorectal cancer. It is in Phase 1 clinical development and has been studied in combination with other agents, including osimertinib, cetuximab, and atezolizumab, in patients with solid tumors and metastatic colorectal cancer.
GDC-1971 is being evaluated for advanced solid tumors, metastatic solid tumors, and colorectal cancer. Clinical trials have also studied it in non-small cell lung cancer in combination with osimertinib. It is an investigational therapy and is not approved for any indication.
GDC-1971 is developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is the sponsor of the clinical trials evaluating the compound in advanced solid tumors and colorectal cancer.
GDC-1971 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one evaluating it with atezolizumab in locally advanced or metastatic solid tumors and another evaluating it with osimertinib or cetuximab in non-small cell lung cancer and metastatic colorectal cancer.
GDC-1971 has been studied in two completed Phase 1 trials. NCT05487235 evaluated GDC-1971 with atezolizumab in locally advanced or metastatic solid tumors and enrolled 57 participants. NCT05954871 evaluated GDC-1971 with osimertinib or cetuximab in non-small cell lung cancer and metastatic colorectal cancer and enrolled 10 participants.
Yes, GDC-1971 trials have used biomarker selection to enroll participants. The Phase 1 studies required patients to be 18 years or older and were conducted across sites in the United States, Australia, South Korea, Argentina, Brazil, Canada, and New Zealand.