AzTrials
AzTrials

Hematological MalignancyPhase 1/2NCT07873827

KATALYST-HEME-01: Study of the KAT6 Inhibitor MEN2312 in Heme Malignancies

A Phase 1/2 study testing MEN2312 in people with Hematological Malignancy, run by Stemline Therapeutics, Inc..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

Search all trials

Trial summary

This study will evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and activity of MEN2312 in participants with hematological malignancies. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hematological Malignancy
What is being tested?
MEN2312
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
No sites listed yet
Study dates
30 Oct 2026to 12 May 2030
Phase
Phase 1/2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant must have a diagnosis of relapsed or refractory acute myeloid leukemia (AML), including de novo or therapy-related AML (tAML) according to World Health Organization (WHO) 2022 and/or International Consensus Classification 2022 (ICC) 2022.
  • Participants must have a leukocyte count < 25,000/microliters (μL) (< 25 × 10^9/liter [L]) prior to Cycle 1 Day 1.
  • Adequate organ function defined as:
  • Renal Function:
  • Calculated creatinine clearance (CrCl) > 50 milliliters (mL)/minute for age-appropriate determination (for example, Cockcroft Gault formula)
  • Hepatic Function:
Show all 15Show fewer
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN)
  • Total serum bilirubin level < 1.5 × ULN (unless due to a known history of Gilbert's disease and Direct Bilirubin is within normal limits [≤ 1 ULN])
  • Cardiac Function:
  • Left ventricular ejection fraction (LVEF) ≥ 50 % or the institutional lower limit of normal, as determined by echocardiogram (ECHO) or multigated acquisition (MUGA) scan performed within 30 days before the first dose of MEN2312.
  • No clinically significant uncontrolled cardiac arrhythmia or other clinically significant cardiac condition that, in the opinion of the Investigator, would increase the risk associated with study participation.
  • Performance Status:
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • Participants must have recovered to Grade ≤ 1 (or baseline, if clinically appropriate) from clinically significant toxicities of prior anticancer therapy, except for alopecia or toxicities considered irreversible and not expected to increase the risk associated with MEN2312, as determined by the Investigator.
  • Participant is able and willing to adhere to the trial visit schedule and other protocol requirements.

Who cannot join

  • Participant received prior treatment with KAT6 inhibitor.
  • Participant has a concurrent malignancy or prior malignancy (except myelodysplastic syndromes [MDS]) and has not been in remission within the 1-year period before screening.
  • Participant with relapsed/refractory (R/R) AML who had received previous Chimeric Antigen Receptor T-cell (CAR-T) treatment for an antecedent hematologic disease.
  • Participant has a diagnosis of blastic transformation of chronic myeloid leukemia (CML) or acute promyelocytic leukemia (APL).
  • Participants with active central nervous system (CNS) involvement by AML are excluded. Participants with a history of CNS leukemia are eligible provided that CNS disease has resolved before the first dose of MEN2312, as demonstrated by at least one negative cerebrospinal fluid (CSF) assessment obtained within 7 days before Cycle 1 Day 1.
  • Any significant medical condition that, in the opinion of the Investigator, would place the participant at unacceptable risk if they were to participate in the trial.
  • Participant is pregnant or breastfeeding.
  • Note: Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Stemline Trials contact

1-877-332-7961

clinicaltrials@menarinistemline.com

About this study

Official title: A Phase 1/2, Open-label, Multicenter Trial to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Efficacy of MEN2312 (KAT6 Inhibitor) in Participants With Hematological Malignancies

This study will evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and activity of MEN2312 in participants with hematological malignancies.

Being tested
MEN2312
Keywords
Small molecule inhibitor of K (lysine) acetyltransferase (KAT) 6, KAT6, MEN2312, Acute myeloid leukemia, AML, Hematological malignancy
Medical subject headings
Hematologic Neoplasms, Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MEN2312Drug

    Oral tablets

Study groups in NCT07873827
Study groupRoleWhat they receive
Part A: MEN2312 Dose EscalationExperimentalParticipants will receive escalating doses of MEN2312 orally once daily (QD) for all days of a 28-day treatment cycle.
Receives: Drug: MEN2312
Part B: MEN2312 Dose OptimizationExperimentalParticipants will receive MEN2312 (at a dose selected based on dose escalation Part A data) orally QD for all days of a 28-day treatment cycle.
Receives: Drug: MEN2312

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Number of Participants With Dose-limiting Toxicities (DLTs)

    Measured: Cycle 1 (28 days)

  2. Part A: Number of Participants Experiencing Severe Toxicity

    Measured: Cycle 1 Day 1 through the completion of Cycle 4 (each cycle length = 28 days) (maximum duration: 112 days)

  3. Part B: Overall Response Rate (ORR) per Central Laboratory Assessment

    Measured: Up to approximately 1.5 years

  4. Part B: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Measured: Up to approximately 1.5 years

Secondary outcomes (20)

  1. Part A: Number of Participants With TEAEs

    Measured: Up to approximately 3.5 years

  2. Part A: ORR Assessed Locally by the Investigator

    Measured: Up to approximately 3.5 years

  3. Part A: Rate of Composite Complete Remission (CRc)

    Measured: Up to approximately 3.5 years

  4. Part B: Rate of Complete Remission (CR)/Complete Remission With Partial Hematologic Recovery (CRh) per Central Laboratory Assessment

    Measured: Up to approximately 3.5 years

  5. Part B: Rate of CRc per Central Laboratory Assessment

    Measured: Up to approximately 3.5 years

  6. Part B: Time to First CR

    Measured: Up to approximately 3.5 years

  7. Part B: Duration of CR

    Measured: Up to approximately 3.5 years

  8. Part B: Time to First CR/CRh

    Measured: Up to approximately 3.5 years

  9. Part B: Duration of CR/CRh

    Measured: Up to approximately 3.5 years

  10. Part B: Time to First CRc

    Measured: Up to approximately 3.5 years

  11. Part B: Duration of CRc

    Measured: Up to approximately 3.5 years

  12. Part B: Time to First Overall Response

    Measured: Up to approximately 3.5 years

  13. Part B: Duration of Overall Response

    Measured: Up to approximately 3.5 years

  14. Part B: Rate of Measurable Residual Disease (MRD) Negativity as Assessed Locally

    Measured: Up to approximately 3.5 years

  15. Part B: Event-free Survival (EFS)

    Measured: Up to approximately 3.5 years

  16. Part B: Overall Survival (OS)

    Measured: Up to approximately 3.5 years

  17. Part B: Percentage of Participants who Proceed to Hematopoietic Stem Cell Transplantation (HSCT)

    Measured: Up to approximately 3.5 years

  18. Part A and Part B: Area Under the Curve (AUC) of MEN2312

    Measured: Cycle 1 Day 1 (during Part A only), Cycle 2 Day 8, and Cycle 1 Day 15 (each cycle length = 28 days)

  19. Part A and Part B: Maximum Plasma Concentration (Cmax) of MEN2312

    Measured: Cycle 1 Day 1 (during Part A only), Cycle 2 Day 8, and Cycle 1 Day 15 (each cycle length = 28 days)

  20. Part A and Part B: Time to Reach Cmax (Tmax) of MEN2312

    Measured: Cycle 1 Day 1 (during Part A only), Cycle 2 Day 8, and Cycle 1 Day 15 (each cycle length = 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2026
  2. Study start30 Oct 2026 (estimated)
  3. Primary completion12 May 2028 (estimated)
  4. Study completion12 May 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Participants will be randomly assigned into Part B dose optimization cohorts to receive a dose of MEN2312 selected based on dose escalation Part A data.
Masking
None (open label)
Enrolment
115 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07873827
Sponsor's protocol ID
MEN2312-02
Other IDs
U1111-1326-7878
Status last verified
Oct 2026
First submitted
8 Oct 2026
Last updated
14 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in