Clinical trial · Interventional
Phase 1 First in Human Study of ZN-d5 as a Single Agent
Phase 1 First in Human Dose-Escalation Study of ZN-d5 as a Single Agent in Subjects With Non-Hodgkin Lymphoma or Acute Myeloid Leukemia
NCT04500587CI-TRIAL-00080564completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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 dose escalation study of ZN-d5 in subjects with relapsed or refractory non-Hodgkin lymphoma (NHL) or acute myeloid leukemia (AML).
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 |
| Non Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ZN-d5 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ZN-d5 Single Agent Dose Escalation - NHL
- description
- Non-Hodgkin Lymphoma
- interventionNames
- Drug: ZN-d5
- type
- EXPERIMENTAL
- label
- ZN-d5 Single Agent Dose Escalation - AML
- description
- Acute Myeloid Leukemia
- interventionNames
- Drug: ZN-d5
Primary outcomes (2)
- measure
- Observed Dose Limiting Toxicities
- timeFrame
- Through completion of Cycle 1; 1 to 2 months.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: NHL: relapsed or refractory NHL including DLBCL, FL, MZL, MCL, LCL, LPL and PTC * Subjects must have received at least 2 prior lines of therapy and have either failed or not be eligible for any available therapies expected to provide clinical benefit and have measurable disease. AML: Primary, secondary, or treatment-related AML, relapsed or refractory to prior therapy, which may include failure of one cycle of induction therapy. * White blood cell count \< 25 × 109/L. Cytoreduction prior to treatment is acceptable. * Subjects may not be pregnant and must agree to use an effective method of contraception. * Eastern Cooperative Oncology Group performance status ≤ 2. * Estimated life expectancy of at least 12 weeks. * Adequate hematologic and organ function, including creatinine clearance ≥ 60 mL/min. Key Exclusion Criteria: * Recent interventions including major surgery, radiation therapy, stem cell transplant. * Treatment with anti-neoplastic agents with 5 half-lives. * Significant unresolved toxicity from prior treatments including active GVHD. * Active central nervous system disease. * Clinically substantial myocardial impairment. * Prior therapy with venetoclax.
References
Publications (0)
Data not yet available
No reference posted for this study.