ClinicalTrials.gg
Sign In
Not yet recruitingNCT07873827Updated Oct 14, 2026

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

A Phase 1/2 interventional study of MEN2312 in Hematological Malignancy, sponsored by Stemline Therapeutics, Inc.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.

Sponsored by Stemline Therapeutics, Inc. (part of Menarini Group) · Phase 1/2, Interventional, and Treatment

Updated Oct 14, 2026Newly registeredGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
115
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Hematological Malignancy

Keywords

  • Small molecule inhibitor of K (lysine) acetyltransferase (KAT) 6
  • KAT6
  • MEN2312
  • Acute myeloid leukemia
  • AML
  • Hematological malignancy
03

In context

Hematologic Neoplasms

1,494 studies on the registry are indexed under Hematologic Neoplasms; 438 are open to participants now.

This study's planned enrollment of 115 is above the median of 45 across 1,090 interventional studies indexed under Hematologic Neoplasms.

Browse Hematologic Neoplasms studies →

Lead sponsor

Stemline Therapeutics, Inc. is the lead sponsor of 23 studies on the registry; 8 are open to participants now.

First submitted after Stemline Therapeutics, Inc. became part of Menarini Group.

Browse Stemline Therapeutics, Inc. studies →All Menarini Group studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • 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:

  • 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.

Key Exclusion Criteria:

  • 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.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
115 participants (estimated)

Study arms

  • Experimental
    Part A: MEN2312 Dose Escalation

    Participants will receive escalating doses of MEN2312 orally once daily (QD) for all days of a 28-day treatment cycle.

    Drug: MEN2312

  • Experimental
    Part B: MEN2312 Dose Optimization

    Participants 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.

    Drug: MEN2312

Interventions

  • DrugMEN2312

    Oral tablets

06

What researchers measure

Primary outcomes

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

    Time frame: Cycle 1 (28 days)

  2. Part A: Number of Participants Experiencing Severe Toxicity

    Time frame: 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

    Time frame: Up to approximately 1.5 years

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

    Time frame: Up to approximately 1.5 years

Secondary outcomes

  1. Part A: Number of Participants With TEAEs

    Time frame: Up to approximately 3.5 years

  2. Part A: ORR Assessed Locally by the Investigator

    Time frame: Up to approximately 3.5 years

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

    Time frame: 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

    Time frame: Up to approximately 3.5 years

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

    Time frame: Up to approximately 3.5 years

  6. Part B: Time to First CR

    Time frame: Up to approximately 3.5 years

  7. Part B: Duration of CR

    Time frame: Up to approximately 3.5 years

  8. Part B: Time to First CR/CRh

    Time frame: Up to approximately 3.5 years

  9. Part B: Duration of CR/CRh

    Time frame: Up to approximately 3.5 years

  10. Part B: Time to First CRc

    Time frame: Up to approximately 3.5 years

  11. Part B: Duration of CRc

    Time frame: Up to approximately 3.5 years

  12. Part B: Time to First Overall Response

    Time frame: Up to approximately 3.5 years

  13. Part B: Duration of Overall Response

    Time frame: Up to approximately 3.5 years

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

    Time frame: Up to approximately 3.5 years

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

    Time frame: Up to approximately 3.5 years

  16. Part B: Overall Survival (OS)

    Time frame: Up to approximately 3.5 years

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

    Time frame: Up to approximately 3.5 years

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

    Time frame: 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

    Time frame: 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

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for May 2028, 18 months later.

Of 67 phase 1/2 interventional studies under Hematologic Neoplasms, half reached primary completion within 77 months of starting (the median), counting those still running; a quarter within 49 and three quarters within 103. This study's planned 18 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 8, 2026
First posted
Oct 14, 2026
StartEst.
Oct 30, 2026
Primary completionEst.
May 12, 2028
CompletionEst.
May 12, 2030
Last update
Oct 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 14, 2026
Show all 1 update
  1. Oct 14, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07873827
Lead sponsor
Stemline Therapeutics, Inc.
Responsible party
Sponsor
First posted
Oct 14, 2026
Start date
Oct 30, 2026 (estimated)
Primary completion
May 12, 2028 (estimated)
Completion
May 12, 2030 (estimated)
Last update
Oct 14, 2026

Study contacts

Stemline Trials
Contact
clinicaltrials@menarinistemline.com
1-877-332-7961
Medical Director
study director · Stemline Therapeutics, Inc.

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hematologic Neoplasms →

Other studies from this sponsor

Stemline Therapeutics, Inc. →

Start the discussion