Phase 1 First in Human Study of ZN-d5 as a Single Agent

K-Group Alpha

Status and phase: Completed; Phase 1

Conditions: Non Hodgkin Lymphoma; Acute Myeloid Leukemia

Treatments: Drug: ZN-d5

Study type: Interventional

Funder types: Industry

Identifiers

NCT04500587

ZN-d5-001

Details and patient eligibility

About

Phase 1 dose escalation study of ZN-d5 in subjects with relapsed or refractory non-Hodgkin lymphoma (NHL) or acute myeloid leukemia (AML).

Full description

This is an open-label multicenter Phase 1 dose escalation study evaluating the safety, tolerability, clinical activity, pharmacokinetics and pharmacodynamics of the novel BCL-2 inhibitor ZN-d5 in subjects with (NHL) or (AML) in order to determine the recommended phase 2 dose of ZN-d5.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

39 participants in 2 patient groups

ZN-d5 Single Agent Dose Escalation - NHL

Experimental group

Description:

Non-Hodgkin Lymphoma

Treatment:

Drug: ZN-d5

ZN-d5 Single Agent Dose Escalation - AML

Experimental group

Description:

Acute Myeloid Leukemia

Treatment:

Drug: ZN-d5