DZ2022B0002 – Blood Cancer Research WA

DZ2022B0002

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)

Non-Hodgkin Lymphoma

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.

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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