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

Lymphoma, Non-Hodgkin Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05824585
• Other study ID #: DZ2022B0002
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 2023
• Est. completion date: October 30, 2027

Study information

• Verified date: March 2023
• Source: Dizal Pharmaceuticals
• Contact: Ziyi Liu
• Phone: +86 021 6109 5852
• Email: ziyi.liu[@]dizalpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: October 30, 2027
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female participants who have provided ICF with age = 18 yrs

2. ECOG performance 0-2, no deterioration in the past 2 weeks

3. Participants with relapsed or refractory B-NHL must have cytologically or histologically confirmed B-cell lymphoma

4. Adequate bone marrow reserve and organ system functions

5. Participants willing to comply with contraceptive restrictions

Exclusion Criteria:

1. Any unresolved > Grade 1 adverse event at the time of starting study treatment with the exception of alopecia.

2. Prior history of allogeneic hematopoietic stem cell transplantation

3. 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

4. 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

5. Participants with non-CNSL presence of CNS or intraocular lymphoma lesions.

6. 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."

7. Participants with infectious disease:

8. Clinically significant cardiac disorders or abnormalities

9. 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.

10. 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

11. Women who are breast feeding

12. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• DZD8586
DZD8586 treatment starting from 50 mg once daily. If tolerated, subsequent cohorts will test increasing doses of DZD8586.

Locations

Country	Name	City	State
Australia	Linear Clinical Research Ltd	Perth	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
Dizal Pharmaceuticals

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A: Incidence of adverse events		30 days after the last dose, assessed up to 2 years
Primary	Part B: Objective Response Rate assessed by investigators		assessed up to 2 years
Secondary	Part A: Objective Response Rate assessed by investigators		assessed up to 2 years
Secondary	Part A: Plasma and CSF concentration of DZD8586		through discontinuation of treatment up to 10 weeks
Secondary	Part B: Duration of Response assessed by investigators		from date of first documented response until the date of documented progression, assessed up to 2 years
Secondary	Part B: Incidence of adverse events		30 days after the last dose, assessed up to 2 years
Secondary	Part B: Plasma and CSF concentration of DZD8586		through discontinuation of treatment, assessed up to 2 years