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DZD8586 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Primary Purpose

Lymphoma, Non-Hodgkin

Status
Not yet recruiting
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
DZD8586
Sponsored by
Dizal Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female participants who have provided ICF with age ≥ 18 yrs ECOG performance 0-2, no deterioration in the past 2 weeks Participants with relapsed or refractory B-NHL must have cytologically or histologically confirmed B-cell lymphoma Adequate bone marrow reserve and organ system functions Participants willing to comply with contraceptive restrictions Exclusion Criteria: Any unresolved > Grade 1 adverse event at the time of starting study treatment with the exception of alopecia. Prior history of allogeneic hematopoietic stem cell transplantation Stem cell transplantation, cell therapy, or gene therapy within 90 days. Approved small molecule therapy within 5 half-lives, investigational small molecule therapy within 14 days. Monoclonal antibodies and antibody-drug conjugates within 28 days Radiation therapy within 1 weeks Live attenuated vaccines or viral vector vaccines within 4 weeks. Major surgery or significant traumatic injury within 4 weeks. History of stroke or intracranial hemorrhage within 6 months Participants with non-CNSL presence of CNS or intraocular lymphoma lesions. CNSL participants with systemic presence of lymphoma, unable to complete lumbar puncture, under systemic corticosteroids at a dose > 8 mg/day (dexamethasone equivalent dose) within 14 days or requiring immunosuppressive or biologic therapy." Participants with infectious disease: Clinically significant cardiac disorders or abnormalities Another malignancy within 5 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uterus, basal or squamous cell carcinoma or non-melanomatous skin cancer. Refractory nausea and vomiting if not controlled by supportive therapy, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption Women who are breast feeding Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol

Sites / Locations

  • Linear Clinical Research Ltd

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DZD8586

Arm Description

Outcomes

Primary Outcome Measures

Part A: Incidence of adverse events
Part B: Objective Response Rate assessed by investigators

Secondary Outcome Measures

Part A: Objective Response Rate assessed by investigators
Part A: Plasma and CSF concentration of DZD8586
Part B: Duration of Response assessed by investigators
Part B: Incidence of adverse events
Part B: Plasma and CSF concentration of DZD8586

Full Information

First Posted
March 30, 2023
Last Updated
April 20, 2023
Sponsor
Dizal Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05824585
Brief Title
DZD8586 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Official Title
A Phase 1, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD8586 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (B-NHL)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
April 30, 2027 (Anticipated)
Study Completion Date
October 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dizal Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study will treat patients with B-NHL who have relapsed, progressed, or were intolerant to systemic therapy progressed following prior therapy. This study will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and assess its anti-cancer activity as monotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DZD8586
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
DZD8586
Intervention Description
DZD8586 treatment starting from 50 mg once daily. If tolerated, subsequent cohorts will test increasing doses of DZD8586.
Primary Outcome Measure Information:
Title
Part A: Incidence of adverse events
Time Frame
30 days after the last dose, assessed up to 2 years
Title
Part B: Objective Response Rate assessed by investigators
Time Frame
assessed up to 2 years
Secondary Outcome Measure Information:
Title
Part A: Objective Response Rate assessed by investigators
Time Frame
assessed up to 2 years
Title
Part A: Plasma and CSF concentration of DZD8586
Time Frame
through discontinuation of treatment up to 10 weeks
Title
Part B: Duration of Response assessed by investigators
Time Frame
from date of first documented response until the date of documented progression, assessed up to 2 years
Title
Part B: Incidence of adverse events
Time Frame
30 days after the last dose, assessed up to 2 years
Title
Part B: Plasma and CSF concentration of DZD8586
Time Frame
through discontinuation of treatment, assessed up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female participants who have provided ICF with age ≥ 18 yrs ECOG performance 0-2, no deterioration in the past 2 weeks Participants with relapsed or refractory B-NHL must have cytologically or histologically confirmed B-cell lymphoma Adequate bone marrow reserve and organ system functions Participants willing to comply with contraceptive restrictions Exclusion Criteria: Any unresolved > Grade 1 adverse event at the time of starting study treatment with the exception of alopecia. Prior history of allogeneic hematopoietic stem cell transplantation Stem cell transplantation, cell therapy, or gene therapy within 90 days. Approved small molecule therapy within 5 half-lives, investigational small molecule therapy within 14 days. Monoclonal antibodies and antibody-drug conjugates within 28 days Radiation therapy within 1 weeks Live attenuated vaccines or viral vector vaccines within 4 weeks. Major surgery or significant traumatic injury within 4 weeks. History of stroke or intracranial hemorrhage within 6 months Participants with non-CNSL presence of CNS or intraocular lymphoma lesions. CNSL participants with systemic presence of lymphoma, unable to complete lumbar puncture, under systemic corticosteroids at a dose > 8 mg/day (dexamethasone equivalent dose) within 14 days or requiring immunosuppressive or biologic therapy." Participants with infectious disease: Clinically significant cardiac disorders or abnormalities Another malignancy within 5 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uterus, basal or squamous cell carcinoma or non-melanomatous skin cancer. Refractory nausea and vomiting if not controlled by supportive therapy, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption Women who are breast feeding Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ziyi Liu
Phone
+86 021 6109 5852
Email
ziyi.liu@dizalpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liu
Organizational Affiliation
Dizal Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Linear Clinical Research Ltd
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Contact:
Phone
+61 08 6382 5100
Email
cancertrialsstartup@linear.org.au

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

DZD8586 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

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