Lymphoma, Non-Hodgkin
Conditions
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.
Interventions
DRUGDZD8586
DZD8586 treatment starting from 50 mg once daily. If tolerated, subsequent cohorts will test increasing doses of DZD8586.
Sponsors
Dizal Pharmaceuticals
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Incidence of adverse events | 30 days after the last dose, assessed up to 2 years |
| Part B: Objective Response Rate assessed by investigators | assessed up to 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Part A: Objective Response Rate assessed by investigators | assessed up to 2 years |
| Part A: Plasma and CSF concentration of DZD8586 | through discontinuation of treatment up to 10 weeks |
| 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 |
| Part B: Incidence of adverse events | 30 days after the last dose, assessed up to 2 years |
| Part B: Plasma and CSF concentration of DZD8586 | through discontinuation of treatment, assessed up to 2 years |
Countries
Australia, United States
Contacts
STUDY_DIRECTORTianwei Zhang
Dizal Pharma
Outcome results
None listed