Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GDC-4198 · 1 trial · 1 indication
Severity of AEs determined according to the CTCAE v5.0 grading scale
| Arm | Type | Description |
|---|---|---|
| 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 | GDC-4198 will be administered orally. |
| Giredestrant | DRUG | Giredestrant will be administered orally. |
| Abemaciclib | DRUG | Abemaciclib will be administered orally. |
Inclusion Criteria: * Histologically and/or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic. * Previously documented ER+ and HER2- tumor according to American Society of Clinical Oncology (ASCO)/ College of American Pathologists (CAP) or European Society ...
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GDC-4198 is an investigational small molecule being studied for the treatment of locally advanced or metastatic estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
GDC-4198 is a small molecule being evaluated in combination with giredestrant for ER+ HER2- breast cancer. Its specific molecular target has not been disclosed in the available clinical trial information, so its mechanism of action is not described here.
GDC-4198 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting a Phase 1 clinical trial of the drug in patients with ER+ HER2- breast cancer.
GDC-4198 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing trial is actively recruiting participants.
GDC-4198 is being studied in a single Phase 1 clinical trial, NCT07100106. This trial evaluates GDC-4198 alone and in combination with giredestrant versus abemaciclib and giredestrant in participants with ER+ HER2- breast cancer. The trial is recruiting in the United States, Australia, Brazil, Canada, China, France, Germany, Italy, South Korea, and Spain.
No, GDC-4198 is not the same as giredestrant. GDC-4198 is the investigational drug being studied, while giredestrant is a separate agent used in combination with GDC-4198 in the clinical trial. The trial compares GDC-4198 plus giredestrant against abemaciclib plus giredestrant.