Clinical trial · Interventional
Study of the ZN-d5 and ZN-c3 in Subjects With Acute Myeloid Leukemia (AML)
A Phase 1/2 Dose Escalation Study of the BCL-2 Inhibitor ZN-d5 and the WEE1 Inhibitor ZN-c3 in Subjects With Acute Myeloid Leukemia
NCT05682170CI-TRIAL-00080768terminatedPhase 1 / Phase 2ClinicalTrials.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): Sponsor decision
Summary
Brief summary (as posted)
A Phase 1/2 dose escalation study of BCL-2 Inhibitor ZN-d5 and the Wee1 Inhibitor ZN-c3 in Subjects with Acute Myeloid Leukemia (AML).
Conditions
Conditions (1)
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 (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ZN-c3 | Drug | — | UNRESOLVED |
| ZN-d5 ZN-c3 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Acute Myeloid Leukemia
- description
- Phase 1: Dose Escalation- c3 monotherapy and d5+c3 combination Phase 2: Dose Expansion
- interventionNames
- Drug: ZN-d5 ZN-c3
- Drug: ZN-c3
Primary outcomes (2)
- measure
- Observed dose limiting toxicities
- timeFrame
- At the end of Cycle 1 (each cycle is 28 days)
- description
- Observed Dose Limiting Toxicities (DLTs) in DLT evaluable subjects.
- measure
- Incidence, severity, and relatedness of adverse events( AEs)
- timeFrame
- Through study completion, typically < 12 months
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults with AML (including secondary or therapy-related), relapsed from or refractory to one or more prior lines of therapy, which may include venetoclax except in Expansion Cohort A * ECOG performance status score ≤2. * Projected life expectancy of at least 12 weeks. * Estimated glomerular filtration rate ≥60 mL/min * Women of childbearing potential must not be pregnant and must use effective birth control during the study and for 6 months after the last dose of study drugs. * Men must agree to use a condom when having intercourse during the study and for 3 months after the last dose of study drugs. Exclusion Criteria: * Known active CNS involvement * Diagnosis of acute promyelocytic leukemia. * Peripheral blast count of \>25 × 109/L (cytoreduction permitted). * Adequate washout from prior therapy including hematopoietic stem cell transplant and recovery from prior treatment-related toxicities to Grade 2 or lower * Significant cardiovascular disease * Corrected QT interval (QTc) of \>480 msec * Active hepatitis B or hepatitis C infection * Concurrent treatment with strong CYP3A inhibitors or strong or moderate CYP3A inducers
References
Publications (0)
Data not yet available
No reference posted for this study.