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

NCT06638307
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Participants
240
clinicaltrials.gov
Lead sponsor
Stemline Therapeutics, Inc.
clinicaltrials.gov
Start date
2024-10-25
clinicaltrials.gov
Number of sites
45
clinicaltrials.gov

Summary
This is a first-in-human study of MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor, in adult participants with advanced breast cancer.
clinicaltrials.gov
Short title
A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer
clinicaltrials.gov
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
clinicaltrials.gov

Control arm
Open label
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2029-10-23
clinicaltrials.gov
First posted
2024-10-15
clinicaltrials.gov
Registry last updated
2026-08-07
clinicaltrials.gov
Primary completion date
2027-10-24
clinicaltrials.gov
Start date
2024-10-25
clinicaltrials.gov

Participants
240
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
240
clinicaltrials.gov
Protocol amendments
3
clinicaltrials.gov
Number of sites
45
clinicaltrials.gov

Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Stemline Therapeutics, Inc.
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT06638307
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06638307
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Number of Participants Experiencing Dose-limiting Toxicity When Administered MEN2312

    Timeframe: Baseline through Day 28

  2. Recommended Phase 2 Dose (RP2D) of MEN2312

    Timeframe: Baseline through Month 6

  1. Overall Response Rate (ORR)

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

  2. Duration of Response (DOR)

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

  3. Clinical Benefit Rate (CBR)

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

  4. Progression-free Survival (PFS)

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

  5. Overall Survival (OS)

    Timeframe: Baseline through 3 months after the last treatment administration (up to approximately 9 months)

  6. Time to Response (TTR)

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

  7. Area Under the Plasma Concentration-time Curve (AUC) of MEN2312 When Administered as Monotherapy

    Timeframe: Up to 6 months post dose

  8. AUC of MEN2312 When Administered as Combination Therapy

    Timeframe: Up to 6 months post dose

  9. Amount of MEN2312 Excreted in Urine When Administered as Monotherapy

    Timeframe: Up to 2 months post dose

  10. Comparison of Plasma Concentration of MEN2312 Monotherapy With MEN2312 Combination Therapy

    Timeframe: Up to 6 months post dose

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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/exclusion criteria may apply.

Sources for eligibility
clinicaltrials.gov

  • Highlands Oncology GroupSpringdale, United StatesRecruiting
  • City of HopeDuarte, United StatesRecruiting
  • UC San Diego Moores Cancer CenterLa Jolla, United StatesRecruiting
  • Stanford Cancer CenterPalo Alto, United StatesRecruiting
  • UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, United StatesRecruiting
  • UCLA Hematology Oncology - ParksideSanta Monica, United StatesRecruiting
  • Yale Comprehensive Cancer CenterNew Haven, United StatesRecruiting
  • Advent Health OrlandoAltamonte Springs, United StatesRecruiting
  • Sarah Cannon Research Institute at Florida Cancer SpecialistsOrlando, United StatesRecruiting
  • Florida Cancer Specialists & Research Institute (FCS) - SarasotaSarasota, United StatesRecruiting
  • Moffitt Cancer CenterTampa, United StatesRecruiting
  • Winship Cancer Institute, Emory UniversityAtlanta, United StatesRecruiting
  • University of Illinois Hospital and Health Sciences System (Outpatient Cancer Center)Chicago, United StatesRecruiting
  • University of Chicago Medical CenterChicago, United StatesRecruiting
  • University of Iowa Health CareIowa City, United StatesRecruiting
  • The University of Kansas Cancer CenterFairway, United StatesRecruiting
  • Sidney Kimmel Comprehensive Cancer CenterBaltimore, United StatesRecruiting
  • Massachusetts General Hospital Cancer CenterBoston, United StatesRecruiting
  • Dana-Farber Cancer InstituteBoston, United StatesRecruiting
  • START Midwest - OncologyGrand Rapids, United StatesRecruiting
  • Mayo ClinicRochester, United StatesRecruiting
  • Astera Cancer CareEast Brunswick, United StatesRecruiting
  • Perlmutter Cancer Center - Sunset ParkBrooklyn, United StatesRecruiting
  • Perlmutter Cancer Center at NYU Langone Hospital - Long IslandMineola, United StatesRecruiting
  • Laura & Isaac Perlmutter Cancer Center at NYU Langone HealthNew York, United StatesRecruiting

And 20 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2024-514661-19-00
  • U1111-1308-5349
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)