Clinical trial NCT05824585: 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
Overall status: RECRUITING
Phase: PHASE1
Conditions: Lymphoma, Non-Hodgkin
Lead sponsor: Dizal Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-04-21
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Part A: Incidence of adverse events
timeFrame: 30 days after the last dose, assessed up to 2 years
measure: Part B: Objective Response Rate assessed by investigators
timeFrame: assessed up to 2 years
Secondary outcomes:
measure: Part A: Objective Response Rate assessed by investigators
timeFrame: assessed up to 2 years
measure: Part A: Plasma and CSF concentration of DZD8586
timeFrame: through discontinuation of treatment up to 10 weeks
measure: Part B: Duration of Response assessed by investigators
timeFrame: from date of first documented response until the date of documented progression, assessed up to 2 years
measure: Part B: Incidence of adverse events
timeFrame: 30 days after the last dose, assessed up to 2 years
measure: Part B: Plasma and CSF concentration of DZD8586
timeFrame: through discontinuation of treatment, assessed up to 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Research site
state: New York
city: Albury
country: Australia
facility: Research site
state: New South Wales
city: Ballarat
country: Australia
facility: Research site
state: Victoria
city: Melbourne
country: Australia
facility: Research site
state: Victoria
city: Perth
country: Australia
facility: Research site
state: Western Australia
Study officials:
affiliation: Dizal Pharma
name: Tianwei Zhang
role: STUDY_DIRECTOR
References: