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

NCT04500587 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: ZN-d5-001
• Study Type: interventional
• Target: 39
• Locations: 7 countries
• Sites: 14

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).

Conditions

Acute Myeloid Leukemia; Non Hodgkin Lymphoma

Keywords

BCL-2 Inhibitors; BH3 mimetics

Outcome Measures

Primary Outcomes (2)

• Observed Dose Limiting Toxicities

  Observed Dose Limiting Toxicities (DLTs) in DLT-evaluable subjects.

  Through completion of Cycle 1; 1 to 2 months.

• Incidence and severity of AEs, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, v 5.0

  Safety profile of ZN-d5.

  Through study completion, typically < 12 months

Secondary Outcomes (6)

• Pharmacokinetic parameters for ZN-d5 - Cmax

  approximately 6 months

• Pharmacokinetic parameters for ZN-d5 - Tmax

  approximately 6 months

• Pharmacokinetic parameters for ZN-d5 - AUC

  approximately 6 months

• For NHL, evaluate response according to the Lugano 2014 classification

  Through study completion, typically < 12 months

• For AML, remission rate based on European LeukemiaNet 2017 criteria

  Through study completion, typically < 12 months

Study Arms (2)

ZN-d5 Single Agent Dose Escalation - NHL

EXPERIMENTAL

Non-Hodgkin Lymphoma

Drug: ZN-d5

ZN-d5 Single Agent Dose Escalation - AML

EXPERIMENTAL

Acute Myeloid Leukemia

Drug: ZN-d5

Interventions

ZN-d5 DRUG

Oral agent; 25 mg or 100 mg formulation

Also known as: Study Drug

ZN-d5 Single Agent Dose Escalation - AML; ZN-d5 Single Agent Dose Escalation - NHL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (14)

Site 2708

Darlinghurst, New South Wales, Australia

Location

Site 2704

Liverpool, New South Wales, Australia

Location

Site 2710

Kurralta Park, South Australia, Australia

Location

Site 2709

Hobart, Tasmania, Australia

Location

Site 1202

Sofia, Bulgaria

Location

Site 1201

Varna, Bulgaria

Location

Site 3201

Zagreb, Croatia

Location

Site 2403

Gdansk, Poland

Location

Site 2901

Pusan, South Korea

Location

Site 2903

Seoul, South Korea

Location

Site 3001

Barcelona, Spain

Location

Site 3005

Bilbao, Spain

Location

Site 3003

Valencia, Spain

Location

Site 2001

Kiev, Ukraine

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Lymphoma, Non-Hodgkin

Interventions

Drug Evaluation

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Officials

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

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 5, 2020
• Study Start: October 13, 2020
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3); AU (4); CR (1); PL (1); KR (2); UA (1); BU (2)