Brief Summary
This is a multicenter, multiple expansion cohort, Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of DR-0201 in adult patients with relapsed or refractory B-cell non-Hodgkin lymphomacancers of the lymphatic system.
Intervention / Treatment
- Drug: DR-0201
Key Inclusion Criteria:
- At least 2 prior lines of therapy and without treatment options that are recognized to offer clinical benefit
- Adequate marrow reserve, renal function, and hepatic function
- Measurable disease defined as ≥ 1 bi-dimensionally measurable nodal lesion of > 1.5 cm in the longest dimension for subjects with PET avid disease for subtypes with nodular disease or at least one bi-dimensionally measurable extranodal lesion, defined as > 1.0 cm in its longest dimension
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status 0-1
- Life expectancy of ≥ 12 weeks
- Use of a highly effective contraceptive measure all males and all females of childbearing potential during study through 180 days post last dosethe amount of medication taken; Females of childbearing potential need to have a negative serum pregnancy test within 7 days prior to first dose.
- Tumor tissuea group of cells that work together to perform a function block or 3 to 5 unstained slides from lymph nodea small lump or mass of tissue in your body or other relevant biopsyremoval of a section of tissue to analyse for cancer cells collected in the past 6 months or subject must be willing to provide a baseline biopsy, unless not safely accessible
- In subjects with prior CAR-T therapy, >90 days post CAR-T at day of first dosing