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Also known as GDC-1971, RO7517834
RLY-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...
RLY-1971 is an investigational small molecule being studied for the treatment of solid tumors in adults. It is intended for patients with advanced or metastatic solid tumors, as evaluated in a Phase 1 clinical trial.
RLY-1971 is being developed by Roche Holding AG, a biopharmaceutical company. The company's stock is traded under the ticker symbol RHHBY.
RLY-1971 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed.
RLY-1971 has been studied in a Phase 1 clinical trial with the identifier NCT04252339. This trial, titled "RLY-1971 in Subjects With Advanced or Metastatic Solid Tumors," enrolled 56 participants in the United States and has been completed.
No alternative names for RLY-1971 have been reported. It is known solely by its code name RLY-1971 in clinical development.