Last update 11 Jul 2024

RLY-2608

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Mechanism
PIK3CA E542K inhibitors, PIK3CA E545K inhibitors, PIK3CA H1047R inhibitors
Inactive Indication-
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhasePhase 1
First Approval Date-
Regulation-

Structure

Molecular FormulaC29H14ClF5N6O2
InChIKeyVYWRYBZVVSPTQN-SANMLTNESA-N
CAS Registry2733573-94-7

R&D Status

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IndicationHighest PhaseCountry/LocationOrganizationDate
Advanced breast cancerPhase 1
FR
08 Dec 2021
Advanced breast cancerPhase 1
ES
08 Dec 2021
Advanced breast cancerPhase 1
US
08 Dec 2021
Advanced breast cancerPhase 1
IT
08 Dec 2021
HER2-negative breast cancerPhase 1
ES
08 Dec 2021
HER2-negative breast cancerPhase 1
FR
08 Dec 2021
HER2-negative breast cancerPhase 1
US
08 Dec 2021
HER2-negative breast cancerPhase 1
IT
08 Dec 2021
Metastatic breast cancerPhase 1
US
08 Dec 2021
Metastatic breast cancerPhase 1
IT
08 Dec 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer | Solid tumor
PIK3CA Mutation | HR Positive | HER2 Negative
42
(unresectable or metastatic solid tumors with a PI3Kα mutation)
(dkscugnhlm) = Among patients receiving doses at target exposures (mono: 400mg BID; combo: 600mg BID & 800mg BID; n=17), AEs were mostly low-grade events that were manageable and reversible:No Grade 3 hyperglycemia, diarrhea, or rash, which are the AEs most commonly associated with treatment discontinuation for existing investigational and approved therapies. jmdxhsrvvi (fyatrbmnco )
Positive
18 Apr 2023
(PI3Kα-mutant, HR+, HER2– locally advanced or metastatic breast cancer)
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Regulation

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