Phase II Study for Patients With Advanced Triple Negative or Metaplastic HR-positive/HER2-negative, PIK3CA/PTEN-altered Breast Cancer Treated With Eribulin in Combination With MEN1611 (SABINA)

NCT05810870 Phase 2 ACTIVE_NOT_RECRUITING

The multicenter, two-cohort, non-comparative, open-label, phase II clinical trial SABINA aims to analyze the safety and efficacy of MEN1611 in monotherapy and in combination with eribulin, a non-taxane chemotherapy agent, in Hormone Receptor (HR)-known/Human Epidermial Growth Factor Receptor 2 (HER2)-negative, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)/ Phosphatase and Tensin Homolog (PTEN)-altered, unresectable locally advanced or metastatic metaplastic breast carcinoma (MpBC) patients. A run-in phase for safety and tolerability of MEN1611 in combination with standard doses of eribulin will be conducted as an initial step of the cohort A. This first step aims at evaluating the dosing schedule of MEN1611, by analyzing the toxicity profile of the combined regimen. With the background of the first-in-human study (PA-001EU), the safe dose of MEN1611 has been established as 48 mg orally BID (two intakes of 3 capsules of 16 mg each, for a total daily dose of 96 mg MEN1611 free-base).

Details

Lead sponsor	MedSIR
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	14
Start date	2023-05-24
Completion	2027-07

Conditions

• Breast Cancer
• Advanced Breast Cancer
• Metastatic Breast Cancer

Interventions

• MEN1611
• Eribulin

Primary outcomes

• To assess the efficacy of MEN1611 in combination with eribulin as determined by the clinical benefit rate (CBR). — Baseline up to at least 12 weeks
  CBR, defined as the percentage of patients who experience a complete response (CR), partial response (PR) or stable disease (SD) for at least 12 weeks after the start of MEN1611 in combination with eribulin treatment, as determined locally by the investigator per RECIST v1.1 criteria.

Countries

Spain