Recruiting NCT06638307
A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MEN2312, Elacestrant.
- Who it may be relevant to
- Registry conditions: Advanced Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, First-in-Human Study of MEN2312, a KAT6 Inhibitor, as Monotherapy and in Combination in Participants With Advanced Breast Cancer
Overview
This is a first-in-human study of MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor, in adult participants with advanced breast cancer.
Interventions
- Drug MEN2312
MEN2312 administered as oral tablets. - Drug Elacestrant
Elacestrant administered as oral tablets.
Primary outcome measures
- Number of Participants Experiencing Dose-limiting Toxicity When Administered MEN2312 [Time frame: Baseline through Day 28]
- Recommended Phase 2 Dose (RP2D) of MEN2312 [Time frame: Baseline through Month 6]
Secondary outcome measures (10)
- Overall Response Rate (ORR) [Time frame: Baseline through 28 days after the last treatment administration (up to approximately 7 months)]
- Duration of Response (DOR) [Time frame: Baseline through 28 days after the last treatment administration (up to approximately 7 months)]
- Clinical Benefit Rate (CBR) [Time frame: Baseline through 28 days after the last treatment administration (up to approximately 7 months)]
- Progression-free Survival (PFS) [Time frame: Baseline through 28 days after the last treatment administration (up to approximately 7 months)]
- Overall Survival (OS) [Time frame: Baseline through 3 months after the last treatment administration (up to approximately 9 months)]
- Time to Response (TTR) [Time frame: Baseline through 28 days after the last treatment administration (up to approximately 7 months)]
- Area Under the Plasma Concentration-time Curve (AUC) of MEN2312 When Administered as Monotherapy [Time frame: Up to 6 months post dose]
- AUC of MEN2312 When Administered as Combination Therapy [Time frame: Up to 6 months post dose]
- Amount of MEN2312 Excreted in Urine When Administered as Monotherapy [Time frame: Up to 2 months post dose]
- Comparison of Plasma Concentration of MEN2312 Monotherapy With MEN2312 Combination Therapy [Time frame: Up to 6 months post dose]
Eligibility criteria
Inclusion criteria
- Participant has advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.
- Presence of genetic alterations in PIK3CA/AKT1/PTEN in participants' tumor tissue.
- Participant must have received at least 1 prior line of endocrine therapy for advanced/metastatic disease or participant who has radiological evidence of breast cancer recurrence or progression during or within 12 months from the end of adjuvant treatment with endocrine therapy, as these participants are considered as first-line relapsed participants.
- Progression on previous cyclin-dependent kinase 4 and 6 inhibitor treatment in combination with fulvestrant or aromatase inhibitor is required.
Exclusion criteria
- Active or newly diagnosed central nervous system metastases.
- Participants with advanced, symptomatic visceral spread, who are at risk of life-threatening complications in the short term, including massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary lymphangitis, or liver involvement >50%.
- Participants with any toxicities related to prior radiation therapy that have not resolved to baseline or to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 Grade ≤1, except alopecia and peripheral sensory neuropathy (Grade ≤2).
Note: Other inclusion/exclusion criteria may apply.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 37 centers
- Highlands Oncology Group — Springdale
- City of Hope — Duarte
- UC San Diego Moores Cancer Center — La Jolla
- Stanford Cancer Center — Palo Alto
- UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco
- UCLA Hematology Oncology - Parkside — Santa Monica
- Yale Comprehensive Cancer Center — New Haven
- Advent Health Orlando — Altamonte Springs
- … and 29 more centers
Spain · 8 centers
- Hospital Universitario Vall d'Hebron - Vall d'Hebron Institute of Oncology (VHIO) Medical — Barcelona
- IOB - Madrid Fundacion Hermanas Hospitalarias (Hospital Beata Maria Ana) — Madrid
- START Madrid - Hospital Universitario Fundacion Jimenez Diaz — Madrid
- Hospital Universitario 12 Octubre Servico de Oncologia Medica — Madrid
- START Madrid - Centro Integral Oncologico Clara Campal (CIOCC), Hospital HM Sanchinarro — Madrid
- Hospital Clinico San Carlos — Madrid
- Hospital Clinico Universitario De Valencia Oncologia Medica — Valencia
- Hospital Universitario y Politecnico La Fe Oncologia Medica — Valencia
Identifiers
NCT: NCT06638307 · MEN2312-01 · 2024-514661-19-00 · U1111-1308-5349