Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05216432 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Dec 31, 2025 to Apr 30, 2027v13 Show 6 more changesShow less
    • Enrollment target: 890 to 930
    • Study sites: 36 to 37
    • Study completion date: Aug 31, 2026 to Apr 30, 2027
    • Eligibility criteria expanded, about 246 words
    • Secondary endpoints: 27 to 26
    • Study title expanded, about 12 words
  2. Enrollment target: 400 to 890v12 Show 6 more changesShow less
    • Primary endpoints revised (6)
    • Study sites: 31 to 36
    • Interventions: Fulvestrant (Drug), Palbociclib 125mg (Drug), RLY-2608 (Drug), Ribociclib 400mg (Drug), Ribociclib 600mg (Drug) to Fulvestrant (Drug), PF-07220060 100mg (Drug), PF-07220060 300 mg (Drug), Palbociclib 125mg (Drug), RLY-2608 (Drug), Ribociclib 400mg…
    • Eligibility criteria expanded, about 83 words
    • Secondary endpoints revised (27)
    • Study arms: 5 to 7
  3. Study sites: 24 to 31v11
  4. Primary completion date: Jan 31, 2025 to Dec 31, 2025v10 Show 5 more changesShow less
    • Primary endpoints revised (6)
    • Study sites: 21 to 24
    • Study completion date: Aug 31, 2025 to Aug 31, 2026
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints: 26 to 27
  5. Enrollment target: 235 to 400v9 Show 6 more changesShow less
    • Primary endpoints: 4 to 6
    • Study sites: 13 to 21
    • Interventions: Fulvestrant (Drug), RLY-2608 (Drug) to Fulvestrant (Drug), Palbociclib 125mg (Drug), RLY-2608 (Drug), Ribociclib 400mg (Drug), Ribociclib 600mg (Drug)
    • Eligibility criteria expanded, about 69 words
    • Secondary endpoints: 19 to 26
    • Study arms: 2 to 5
Show 7 earlier versionsHide 7 earlier versions
  1. Enrollment target: 190 to 235
    • Eligibility criteria expanded, about 31 words
    • Secondary endpoints: 17 to 19
    v8
  2. Study sites: 10 to 13v7
  3. Re-verified, no change to tracked fieldsv6
  4. Study sites: 8 to 10v5
  5. Study sites: 6 to 8v4
  6. Site details revised at 1 of 6 sitesv3
  7. Study sites: 5 to 6v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 + fulvestrant + CDK4/6 inhibitor (palbociclib or ribociclib) or CDK4 inhibitor (PF-07220060) for patients with HR+ HER2- locally advanced or metastatic breast cancer. The RLY-2608 single agent arm, RLY-2608 + fulvestrant combination arm, and triple combination arms will have 2 parts: a dose escalation (Part 1) and a dose expansion (Part 2).
Trial Details
NCT Number NCT05216432
Lead Sponsor Relay Therapeutics, Inc.
Conditions
(from sponsor)		 PIK3CA Mutation, Solid Tumor, Adult, HER2-negative Breast Cancer, Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer, Unresectable Solid Tumor
Related terms Breast Neoplasms
Enrollment 930 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov