I/II Phase Study Evaluating M1774 in Combination With Fulvestrant in HR+ and HER2- Advanced Breast Cancers

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

May 1, 2024

Primary Completion Date

April 1, 2027

Study Completion Date

October 15, 2027

Conditions
Breast Cancer
Interventions
DRUG

M1774

• Phase I part = administration of M1774 in combination with fulvestrant in ER+/HER2- ABC resistant to CDK4/6 inhibitor and aromatase inhibitor-based endocrine therapy in order to detemine the recommended phase II dose Phase II part = administration of M1774 at RP2D in combination with fulvestrant

DRUG

Fulvestrant injection

Phase I part = administration of M1774 in combination with fulvestrant in ER+/HER2- ABC resistant to CDK4/6 inhibitor and aromatase inhibitor-based endocrine therapy in order to detemine the recommended phase II dose Phase II part = administration of M1774 at RP2D in combination with fulvestrant

Trial Locations (1)

13009

Institut Paoli Calmettes, Marseille

All Listed Sponsors
collaborator

National Cancer Institute, France

OTHER_GOV

collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

lead

Institut Paoli-Calmettes

OTHER

NCT05986071 - I/II Phase Study Evaluating M1774 in Combination With Fulvestrant in HR+ and HER2- Advanced Breast Cancers | Biotech Hunter | Biotech Hunter