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

NCT ID: NCT04500587

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-13
• Study Completion Date: 2023-12-12

Brief Summary

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

Detailed 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.

Conditions

Acute Myeloid Leukemia; Non Hodgkin Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ZN-d5 Single Agent Dose Escalation - NHL

Non-Hodgkin Lymphoma

Group Type: EXPERIMENTAL

ZN-d5

Intervention Type: DRUG

Oral agent; 25 mg or 100 mg formulation

ZN-d5 Single Agent Dose Escalation - AML

Acute Myeloid Leukemia

Group Type: EXPERIMENTAL

ZN-d5

Intervention Type: DRUG

Oral agent; 25 mg or 100 mg formulation

Interventions

ZN-d5

Oral agent; 25 mg or 100 mg formulation

Intervention Type: DRUG

Other Intervention Names

Study Drug

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

K-Group Alpha Inc. /a subsidiary of Zentalis Pharmaceuticals

Role: STUDY_DIRECTOR

K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.

Locations

Site 2708

Darlinghurst, New South Wales, Australia

Site 2704

Liverpool, New South Wales, Australia

Site 2710

Kurralta Park, South Australia, Australia

Site 2709

Hobart, Tasmania, Australia

Site 1202

Sofia, , Bulgaria

Site 1201

Varna, , Bulgaria

Site 3201

Zagreb, , Croatia

Site 2403

Gdansk, , Poland

Site 2901

Pusan, , South Korea

Site 2903

Seoul, , South Korea

Site 3001

Barcelona, , Spain

Site 3005

Bilbao, , Spain

Site 3003

Valencia, , Spain

Site 2001

Kiev, , Ukraine

Countries

Australia; Bulgaria; Croatia; Poland; South Korea; Spain; Ukraine

Other Identifiers

ZN-d5-001

Identifier Type: -

Identifier Source: org_study_id