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MATRIX-IPC 2022-029 A phase I/II study evaluating Tuvusertib (M1774), an ATR Inhibitor, in combination with fulvestrant in hormone receptors-positive and HER2-negative, advanced breast cancers, resistant to CDK4/6 inhibitor plus aromatase inhibitor-based endocrine treatment and with homologous recombination deficiency, oncogenic driver activation and/or other molecular alterations associated with replication stress (RS)

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507485-10-00
Enrollment
57
Registered
2024-04-05
Start date
2025-09-09
Completion date
Unknown
Last updated
2025-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced breast cancer

Brief summary

incidence of dose-limiting toxicity

Detailed description

Tolerance: incidence of AEs and Serious Adverse Events (SAE) presented by grade according to the NCI-CTCAE v5.0., overall response rate (ORR) as defined as the percent of patients with a complete response (CR) or a partial response (PR) (RECIST v1.1)., The progression-free survival (PFS) as defined as the interval between the date of inclusion and the date of progression or death. A patient alive and without progression will be censored at the last date of follow-up., PK evaluation will be performed on typical individual pharmacokinetics parameters (

Interventions

DRUGM1774 50mg
DRUGFULVESTRANT
DRUGM1774 30mg

Sponsors

Institut Paoli-Calmettes
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
incidence of dose-limiting toxicity

Secondary

MeasureTime frame
Tolerance: incidence of AEs and Serious Adverse Events (SAE) presented by grade according to the NCI-CTCAE v5.0., overall response rate (ORR) as defined as the percent of patients with a complete response (CR) or a partial response (PR) (RECIST v1.1)., The progression-free survival (PFS) as defined as the interval between the date of inclusion and the date of progression or death. A patient alive and without progression will be censored at the last date of follow-up., PK evaluation will be performed on typical individual pharmacokinetics parameters (

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026