GDC-4198
DrugGDC-4198 will be administered orally.
Other names: RGT-419B, RO7840734
NCT Number: NCT07100106
The purpose of this study is to assess the safety of GDC-4198 alone and in combination with giredestrant and also the efficacy of GDC-4198 + giredestrant versus abemaciclib + giredestrant in participants with locally advanced or metastatic ER+, HER2- breast cancer. The study consists of 2 phases: Phase Ib and Phase II. Phase Ib will evaluate the safety and pharmacokinetics (PK) of GDC-4198 alone and in combination with giredestrant. Phase II stage will compare the activity and safety of GDC-4198 and giredestrant with abemaciclib and giredestrant.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1 / Phase 2
St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
GDC-4198 will be administered orally.
Other names: RGT-419B, RO7840734
Giredestrant will be administered orally.
Other names: GDC-9545, RO7197597
Abemaciclib will be administered orally.
Time frame: Up to 36 months
Severity of AEs determined according to the CTCAE v5.0 grading scale
Time frame: From Day 1 to Day 28 of Cycle 1 (1 cycle=28 days)
Time frame: Up to 36 months
Time frame: Up to 36 months
Time frame: Up to 36 months
Time frame: Up to 36 months
Time frame: Up to 36 months
Time frame: Up to 36 months
Time frame: Up to 36 months
Time frame: Month 6, Month 12
Time frame: Month 6, Month 12
Time frame: Up to 36 months
Severity of AEs determined according to the CTCAE v5.0 grading scale
Time frame: Up to 36 months
Time frame: Up to 36 months
Contact information is provided by the study sponsor or research team.
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
CONTACT
Reference Study ID Number: GO46021 https://forpatients.roche.com/ No attachments to email below.
CONTACT
888-662-6728 (U.S. Only)
Genentech, Inc.
Industry
A Phase Ib/II Multicenter, Open-Label, Randomized Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-4198 Alone and in Combination With Giredestrant in Comparison With Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive, HER2-Negative Breast Cancer Who Have Previously Progressed During or After a CDK4/6 Inhibitor
Acronym: MoonROSE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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