DS-3201b in Participants With Lymphomas

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Daiichi Sankyo

Status and phase

Active, not recruiting
Phase 1


Lymphoma, Malignant
Non-hodgkin Lymphoma


Drug: DS-3201b

Study type


Funder types



163173 (Registry Identifier)

Details and patient eligibility


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:

  • has come back after remission
  • is not responding to current treatment

This study has three parts:

  1. Dose Escalation is to find the safe dose of DS-3201b that adults with advanced NHL can tolerate.

  2. Dose Expansion is to:

    • find out how effective DS-3201b is for rare types of NHL
    • collect additional safety data
  3. 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


100 estimated patients




18+ years old


No Healthy 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:

    1. willing to provide archived or fresh tumor tissue samples that are sufficient for comprehensive genomic and/or proteomic analyses at baseline

    2. [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

    3. willing to provide optional fresh end-of-treatment biopsy

For ATL subjects:

  • Has a positive test result for human T-lymphotropic virus type I antibody
  • Has ATL subtype classified as acute, lymphomatous, or chronic with poor prognostic factor
  • Has diagnosis of relapse (including relapse after partial remission [PR]) or treatment-resistant ATL at the time of informed consent after prior treatment with at least 1 anti-cancer medication regimen

Exclusion criteria

  • Has been diagnosed with protocol-defined cutaneous T-cell lymphoma or T-cell leukemia. For DDI cohort, CTCL is not exclusionary.
  • Has a history or presence of central nervous system (CNS) involvement
  • Has a medical history, complication or other malignancy considered inappropriate for participation in the study, or a serious physical or psychiatric disease, the risk of which may be increased by participation in the study
  • Has received drugs or other treatments not allowed by the protocol
  • History of treatment with other enhancer of zeste (EZH) inhibitors
  • Has had allogeneic hematopoietic stem cell transplantation (HTCP) within 90 days before scheduled dosing on Cycle 1 Day 1
  • Is pregnant or breastfeeding
  • Is otherwise deemed ineligible to participate by the investigator or sub-investigator

DDI Cohort Only:

  • Has received following medications within 14 days prior to study drug administration
  • Any CYP3A inhibitors/inducers including weak CYP3A inhibitors/inducers, and P-gp inhibitors, midazolam as well as digoxin

Trial design

Primary purpose




Interventional model

Single Group Assignment


None (Open label)

100 participants in 1 patient group

Experimental group
Drug: DS-3201b

Trial contacts and locations



Data sourced from

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