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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-15

Study Completion Date

2027-10-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Lymphoma, Non-Hodgkin

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DZD8586

Group Type EXPERIMENTAL

DZD8586

Intervention Type DRUG

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

Interventions

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DZD8586

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No