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Also known as RGT-419B, RO7840734
GDC-4198 · 2 trials · 2 indications
Severity of AEs determined according to the CTCAE v5.0 grading scale
| Arm | Type | Description |
|---|---|---|
| GDC-4198 with fulvestrant | EXPERIMENTAL | During safety run-in stage, participants will receive GDC-4198, higher dose in combination with fulvestrant, as per a pre-defined dosing regimen during Cycle 1 (1 cycle=28 days). During expansion stage, participants will receive GDC-4198, either lower or higher dose in combination with fulvestrant, as per a pre-defined dosing regimen during each cycle until unacceptable toxicity or disease progression. |
| GDC-4198 with letrozole | EXPERIMENTAL | During expansion stage, participants will receive GDC-4198, either lower or higher dose in combination with letrozole, as per a pre-defined dosing regimen during each cycle until unacceptable toxicity or disease progression. |
| GDC-4198 with giredestrant | EXPERIMENTAL | During expansion stage, participants will receive GDC-4198, either lower or higher dose in combination with giredestrant, as per a pre-defined dosing regimen during each cycle until unacceptable toxicity or disease progression. |
| Phase Ib: Dose-Finding Stage | EXPERIMENTAL | Participants will receive GDC-4198 as monotherapy and in combination with giredestrant, 30 milligrams (mg), orally, daily, as per a pre-defined dosing regimen during each cycle until unacceptable toxicity or disease progression and/or loss of clinical benefit. (1 cycle=28 days). |
| Phase II: Arm A | EXPERIMENTAL | Participants will receive GDC-4198, higher dose, in combination with giredestrant, 30 mg, orally, daily, as per a pre-defined dosing regimen during each cycle until unacceptable toxicity or disease progression and/or loss of clinical benefit. (1 cycle=28 days). |
| Phase II: Arm B | EXPERIMENTAL | Participants will receive GDC-4198, lower dose, in combination with giredestrant, 30 mg, orally, daily, as per a pre-defined dosing regimen during each cycle until unacceptable toxicity or disease progression and/or loss of clinical benefit. (1 cycle=28 days). |
| Phase II: Arm C | EXPERIMENTAL | Participants will receive abemaciclib, 150 mg twice daily, in combination with giredestrant, 30 mg, orally, daily, as per a pre-defined dosing regimen during each cycle until unacceptable toxicity or disease progression and/or loss of clinical benefit. (1 cycle=28 days). |
| Name | Type | Description |
|---|---|---|
| GDC-4198 | DRUG | Participants will receive GDC-4198 as per the schedule described in the protocol. |
| Fulvestrant | DRUG | Participants will receive fulvestrant as per the schedule described in the protocol. |
| Letrozole | DRUG | Participants will receive letrozole as per the schedule described in the protocol. |
| Giredestrant | DRUG | Participants will receive giredestrant as per the schedule described in the protocol. |
| Abemaciclib | DRUG | Abemaciclib will be administered orally. |
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic and HER2-negative disease. * Disease documented HER2-negative tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guid...
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GDC-4198 is an investigational small molecule being developed by Roche Holding AG for the treatment of advanced or metastatic breast cancer. It is currently in Phase 1 clinical development and has not been approved by the FDA. It is being studied both as a single agent and in combination with other endocrine therapies.
GDC-4198 is being evaluated for locally advanced or metastatic hormone receptor-positive, HER2-negative breast cancer, including estrogen receptor-positive disease. Trials are studying it in combination with letrozole, fulvestrant, or giredestrant, and also alone or combined with giredestrant versus abemaciclib plus giredestrant.
GDC-4198 is developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is sponsoring the clinical program evaluating the compound in breast cancer, including a Phase 1 study comparing it with abemaciclib in combination with giredestrant.
GDC-4198 is in Phase 1 clinical development. It is an investigational agent and has not received FDA approval. Two Phase 1 trials are registered, one currently recruiting and one not yet recruiting, with a combined planned enrollment of 450 participants across both studies.
GDC-4198 is being studied in NCT07100106, a recruiting Phase 1 trial of GDC-4198 alone and with giredestrant versus abemaciclib plus giredestrant in ER-positive, HER2-negative breast cancer, and in NCT07867262, a not-yet-recruiting Phase 1 trial combining GDC-4198 with letrozole, fulvestrant, or giredestrant.