Clinical trial · Interventional
Study of SGR-2921 in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
A First-In-Human, Phase 1, Dose Escalation Study of SGR-2921 as Monotherapy In Subjects With Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
NCT05961839CI-TRIAL-00095532terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Company decision
Summary
Brief summary (as posted)
The purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) and/or recommended dose (RD) of SGR-2921.
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 |
| High-Risk and Very High-Risk Myelodysplastic Syndromes | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SGR-2921 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Escalation in the Absence of Specific Azole Antifungal Treatments
- description
- Up to 9 dose levels will be evaluated in subjects not receiving specific azole antifungal treatment.
- interventionNames
- Drug: SGR-2921
- type
- EXPERIMENTAL
- label
- Dose Escalation in the Presence of Specific Azole Antifungal Treatments
- description
- Up to 9 dose levels will be evaluated in subjects receiving specific azole antifungal treatment.
- interventionNames
- Drug: SGR-2921
Primary outcomes (3)
- measure
- Dose Limiting Toxicities
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥ 18 years of age. * Life expectancy ≥ 8 weeks. * Confirmed diagnosis of R/R AML or High Risk (HR) and Very High Risk (VHR) MDS. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. Exclusion Criteria: * Active malignancies within two years prior to the first dose, or requiring ongoing treatment, not related to AML or MDS. * Clinical evidence of central nervous system (CNS) or pulmonary leukostasis, ≥ Grade 3 disseminated intravascular coagulation, or active CNS leukemia. * Use of experimental drug, or therapy, or anti-cancer therapy within 14 days or 5 half-lives of the first dose of study drug. * QT interval corrected for heart rate per Fridericia's formula ≥470 msec during screening ECG.
References
Publications (0)
Data not yet available
No reference posted for this study.