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NCT07250646
A Phase 1 Study of Rebecsinib, a Spliceosome Modulator That Inhibits ADAR1, in Patients With Relapsed or Refractory Secondary Acute Myeloid Leukemia or Higher-Risk Myelofibrosis
Phase 1 trial testing rebecsinib in Secondary AML in 28 participants. Currently enrolling.
1 October 2027
Quick facts
| Lead sponsor | Aspera Biomedicines, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 28 |
| Start date | 21 May 2026 |
| Primary completion | 1 October 2027 |
| Estimated completion | 1 April 2028 |
| Sites | 1 location across United States |
Drugs / interventions tested
- rebecsinib — full drug profile →
Conditions studied
- Secondary AML — all drugs for Secondary AML →
- Myelofibrosis — all drugs for Myelofibrosis →
Sponsor
Aspera Biomedicines, Inc. — full company profile →
Who can join
18 and older, any sex, with Secondary AML or Myelofibrosis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Determine the Maximum Tolerated Dose
Time frame: From first dose through 28 days after initial dose for dose all finding cohorts, approximately 2 years.
Find the rate of dose limiting toxicities (DLTs) to establish the maximum tolerated dose (MTD) or biologically active dose of rebecsinib when given on days 1, 4, 8, and 11 of each 28 days cycle. -
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: From enrollment to initiation of new therapy for each subject, approximately 4 months.
To determine the safety and tolerability of rebecsinib by ongoing evaluation of treatment-emergent adverse events (AEs) by collecting description, timing, grade \[CTCAE v5.0\], severity, seriousness, and relatedness of all events.
Sponsor's own description
The purpose of this study is to test the safest and most effective dose of a new investigational drug, rebecsinib. Participants in this study will have either Secondary Acute Myeloid Leukemia (sAML) that has either returned (relapsed) or not responded to treatment (refractory) or have higher risk Myelofibrosis (MF). Participants will receive a study drug infusion on Day 1, Day 4, Day 8 and Day 11 of each 28-day cycle for a total of 6 cycles.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07250646
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07250646 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Aspera Biomedicines, Inc.
- Last refreshed: 2 June 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07250646.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing