Health TrialsbyHealthPanel

A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer

ConditionAdvanced Breast Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorStemline Therapeutics, Inc.

About this trial

This is a first-in-human study of MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor, in adult participants with advanced breast cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Sequential

Treatments tested in this trial

  • MEN2312

    Drug

    MEN2312 administered as oral tablets.

  • Elacestrant

    Drug

    Elacestrant administered as oral tablets.

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: MEN2312: MonotherapyExperimental treatment 1 intervention
Group B: MEN2312: Combination Therapy (Elacestrant)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of Participants Experiencing Dose-limiting Toxicity When Administered MEN2312

Time frame
Baseline through Day 28
2

Recommended Phase 2 Dose (RP2D) of MEN2312

Time frame
Baseline through Month 6

Secondary outcomes

1

Overall Response Rate (ORR)

Time frame
Baseline through 28 days after the last treatment administration (up to approximately 7 months)
2

Duration of Response (DOR)

Time frame
Baseline through 28 days after the last treatment administration (up to approximately 7 months)
3

Clinical Benefit Rate (CBR)

Time frame
Baseline through 28 days after the last treatment administration (up to approximately 7 months)
4

Progression-free Survival (PFS)

Time frame
Baseline through 28 days after the last treatment administration (up to approximately 7 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stemline Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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