First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer

This is an open-label, FIH study designed to evaluate the maximum tolerated dose, recommended Phase 2 dose, safety, tolerability, PK, pharmacodynamics, and preliminary antineoplastic activity of RLY-2608, in advanced solid tumor patients with a Phosphatidylinositol-4,5-bisphosphate-3 kinase, catalytic subunit alpha (PIK3CA) mutation in blood and/or tumor per local assessment. The study will evaluate RLY-2608 as a single agent for patients with unresectable or metastatic solid tumors. It will also evaluate RLY-2608 in combination RLY-2608 + fulvestrant and in triple combination RLY-2608 + fulve

Trial Details

NCT ID
NCT05216432
Phase
PHASE1
Sponsor
Relay Therapeutics, Inc.
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • RLY-2608
  • Fulvestrant
  • Palbociclib 125mg
  • Ribociclib 400mg
  • Ribociclib 600mg
  • PF-07220060 100mg
Locations (sample)
  • Tucson, Arizona, United States|32.22174,-110.92648
  • San Diego, California, United States|32.71571,-117.16472
  • Denver, Colorado, United States|39.73915,-104.9847
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Orlando, Florida, United States|28.53834,-81.37924

Key Eligibility Criteria

  • Patient has ECOG performance status of 0-1
  • One or more documented primary oncogenic PIK3CA mutation(s) in blood and/or tumor per local assessment
  • Other potentially oncogenic PIK3CA mutations may be considered but must be approved by the Sponsor prior to enrollment.
  • Part 1 \[Escalation\] - Ability to provide archived tumor tissue or be willing to undergo pretreatment tumor biopsy to assess PIK3CA status retrosp…

For full eligibility, visit ClinicalTrials.gov.

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