Clinical Trial

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 In Combination With 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

MOA: GDC-4198 is a CDK4/2 inhibitor, developed to address the key resistance mechanism to CDK4/6 inhibitors.

Key Eligibility:

• ER+ (≥ 1%), HER-negative (local testing) LA or MBC
• PD on/after tx with CDK4/6 inhibitor and ET in the LA/MBC
  setting
  • More than 1 line of tx for LA/MBC are excluded
  • Prior chemotherapy for MBC excluded
  • Tx with approved oral ET within 7 days prior to initiation of study
    drug or tx with fulvestrant/approved CDK4/6 inhibitor within 21
    days prior to initiation of study drug are excluded
• Measurable/non-measurable evaluable (including bone only)
  disease per RECIST v1.1
• Most recent collected and representative tumor tissue must be
  provided
• Known and untreated or active CNS metastases are excluded