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About
DS-3201b is an experimental drug. It is not approved for regular use. It can only be used in clinical research.
Adults with non-Hodgkin lymphoma (NHL) might be able to join this study if their disease:
This study has three parts:
Dose Escalation is to find the safe dose of DS-3201b that adults with advanced NHL can tolerate.
Dose Expansion is to:
Drug-Drug Interaction (DDI) Cohort (US Only) is to evaluate the effect of DS-3201b on the pharmacokinetics (PK) midazolam and digoxin when co-administered to patients with NHL
Enrollment
Sex
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Volunteers
Inclusion criteria
Has hematocytological or pathological diagnosis of non- Hodgkin's lymphoma (NHL)
Has relapsed from or is refractory to standard treatment or no standard treatment is available
Is the age of majority in their country (18 in the US and 20 in Japan) at the time of informed consent
Has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Has at least one evaluable lesion site (not applicable for the DDI cohort)
Has preserved organ function based on baseline laboratory data at screening tests
If of reproductive potential, agrees to avoid harvesting ova or sperm, and to use a protocol-defined form of contraception or avoid intercourse, during and upon completion of the study, and for at least 3 months after the last dose of study drug
Tumor biopsy collections:
willing to provide archived or fresh tumor tissue samples that are sufficient for comprehensive genomic and/or proteomic analyses at baseline
[US only] willing to provide fresh on-treatment tumor biopsy if deemed acceptable risk by the investigator
[Japan only] fresh on-treatment tumor biopsy should be performed if deemed acceptable risk by the investigator
willing to provide optional fresh end-of-treatment biopsy
For ATL subjects:
Exclusion criteria
DDI Cohort Only:
Primary purpose
Allocation
Interventional model
Masking
100 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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