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NCT05216432 (RLY-2608 in Advanced Breast Cancer): BVCT ex-ante prediction vs. reported outcome

On 11 Jul 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 9 Sep 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (ORR/PFS non-superior to alpelisib + fulvestrant) and commercially TBD.

Clinical Trial

NCTID
NCT05216432
Acronym
ReDiscover
Drug Name
RLY-2608
Drug MoA
pan-mutant-selective (H1047X; E542X; and E535X) PI3Kalpha inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Advanced Breast Cancer
Human Patients
400
Sponsor
Relay Therapeutics
Phase
Phase 1

Prediction of , index 975

Prospective Prediction
Prediction Index
975
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit in OS inferior to alpelisib; in combination with fulvestrant and/or palbociclib/ribociclib)
Technical Prediction
partial SUCCESS (statistically maybe significant yet very weak additive clinical benefit in ORR/PFS non-superior to alpelisib; in combination with fulvestrant and/or palbociclib/ribociclib)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
60 days in advance
Readout Data Interpretation
RLY2608 + fulvestrant achieved 30% confirmed ORR and 9.2months mPFS vs. 26.6% confirmed ORR and 11months mPFS achieved by alpelisib + fulvestrant.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (ORR/PFS non-superior to alpelisib + fulvestrant) and commercially TBD
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
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
Phase
Phase 1
Status
Recruiting
Enrollment
930
Lead sponsor
Relay Therapeutics, Inc.
Conditions
PIK3CA Mutation; Solid Tumor, Adult; HER2-negative Breast Cancer; Breast Cancer; Metastatic Breast Cancer; Advanced Breast Cancer; Unresectable Solid Tumor
Interventions
DRUG: RLY-2608; DRUG: Fulvestrant; DRUG: Palbociclib 125mg; DRUG: Ribociclib 400mg; DRUG: Ribociclib 600mg; DRUG: PF-07220060 100mg; DRUG: PF-07220060 300 mg
Design
Non randomized · Parallel · None
Primary purpose
Treatment
Start
2021-12-08
Primary completion
2027-04-30
Completion
2027-04-30
Primary outcomes
  • Determination of maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of RLY-2608 as a single agent (Cycle 1 (4-week cycle) of treatment for MTD and at the end of every cycle (4-week cycles) for RP2D until study discontinuation, approximately 24 months)
  • Determination of maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of RLY-2608 in combination with fulvestrant (Cycle 1 (4-week cycle) of treatment for MTD and at the end of every cycle (4-week cycles) for RP2D until study discontinuation, approximately 24 months)
  • Determination of maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of RLY-2608 in combination with fulvestrant and a CDK 4/6 inhibitor (palbociclib, ribociclib), and in combination with CDK4 inhibitor (PF-07220060) and fulvestrant (Cycle 1 (4-week cycle) of treatment for MTD and at the end of every cycle (4-week cycles) for RP2D until study discontinuation, approximately 24 months)
  • Number of patients with adverse events and serious adverse events of RLY-2608 as a single agent (Every cycle (4-week cycles) until study discontinuation, approximately 24 months)
  • Number of patients with adverse events and serious adverse events of RLY-2608 in combination with fulvestrant (Every cycle (4-week cycles) until study discontinuation, approximately 24 months)

NCT05216432 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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