Advanced Breast Cancer
Conditions
Keywords
First-In-Human, MEN2312, Advanced Breast Cancer, KAT6
Brief summary
This is a first-in-human study of MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor, in adult participants with advanced breast cancer.
Interventions
DRUGMEN2312
MEN2312 administered as oral tablets.
DRUGElacestrant
Elacestrant administered as oral tablets.
Sponsors
Stemline Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key 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. Key
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Experiencing Dose-limiting Toxicity When Administered MEN2312 | Baseline through Day 28 |
| Recommended Phase 2 Dose (RP2D) of MEN2312 | Baseline through Month 6 |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate (ORR) | Baseline through 28 days after the last treatment administration (up to approximately 7 months) |
| Duration of Response (DOR) | Baseline through 28 days after the last treatment administration (up to approximately 7 months) |
| Clinical Benefit Rate (CBR) | Baseline through 28 days after the last treatment administration (up to approximately 7 months) |
| Progression-free Survival (PFS) | Baseline through 28 days after the last treatment administration (up to approximately 7 months) |
| Overall Survival (OS) | Baseline through 3 months after the last treatment administration (up to approximately 9 months) |
| Time to Response (TTR) | 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 | Up to 6 months post dose |
| AUC of MEN2312 When Administered as Combination Therapy | Up to 6 months post dose |
| Amount of MEN2312 Excreted in Urine When Administered as Monotherapy | Up to 2 months post dose |
| Comparison of Plasma Concentration of MEN2312 Monotherapy With MEN2312 Combination Therapy | Up to 6 months post dose |
Countries
Spain, United States
Contacts
CONTACTStemline Trials
Outcome results
None listed