Clinical trial · Interventional
Safety Study of ALRN-6924 in Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome
A Phase 1/1b Open-Label Study to Determine the Safety and Tolerability of ALRN-6924 Alone and in Combination With Cytarabine (Ara-C) in Patients With Relapsed/Refractory Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome With Wild-Type TP53
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase 1/1b, open label, multi-center dose escalation and dose expansion study designed to evaluate safety, tolerability, PK (pharmacokinetics), PD (pharmacodynamics) and anti-tumor effects of ALRN-6924 alone or in combination with cytarabine in patients with relapsed/refractory acute myeloid leukemia or advanced myelodysplastic syndrome with wild-type (WT) TP53
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ALRN-6924 | Drug | — | UNRESOLVED |
| ALRN-6924 in combination with cytarabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ALRN-6924
- description
- Fixed dose of ALRN-6924 per cohort, administered IV, Days 1, 8, and 15 every 28 days
- interventionNames
- Drug: ALRN-6924
- type
- EXPERIMENTAL
- label
- ALRN-6924 in combination with cytarabine
- description
- Cytarabine (100 or 200 mg/m2) will be administered as an IV infusion followed by ALRN-6924 on Days 1, 8, and 15 every 28 days.
- interventionNames
- Drug: ALRN-6924 in combination with cytarabine
Primary outcomes (2)
- measure
- Evaluate the safety and tolerability of ALRN-6924 alone and in combination with cytarabine
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Relapsed or refractory acute myeloid leukemia or IPSS-R intermediate/high/very high-risk MDS patients * Confirmed or anticipated wild-type TP53 * ECOG (Eastern Cooperative Oncology Group) performance status 0-2 * Adequate hepatic and renal function * Acceptable coagulation function * Negative serum or urine pregnancy test within 7 days prior to the first dose of ALRN-6924 for women of child-bearing potential * Sufficient wash out from prior therapies and recovery from all significant toxicities Exclusion Criteria: * Patients are eligible for available approved standard therapies * Prior treatment with MDM2 inhibitor, with protocol specified exceptions * Patients with history of allogeneic stem cell transplantation * Leukemic blast counts of \>25,000/µl * Deletion of chromosome 17, or del(17p) * Patients with evidence of current central nervous system leukemic involvement * Known hypersensitivity to any study drug component * History of coagulopathy * Prior specified cardiovascular risk factors * Clinically significant gastrointestinal bleeding within 6 months * Clinically significant third-space fluid accumulation * Pregnant or lactating females * Evidence of any serious and/or unstable pre-existing medical condition that would interfere with patient safety ability to provide informed consent * Active uncontrolled infection, including HIV/AIDS or Hepatitis B or C * Second malignancy within one year, with protocol specified exceptions
References
Publications (0)
Data not yet available