Skip to Main Content
Phase I

A Phase 1 Multiple Ascending Dose Study of DS-3201b in Subjects With Lymphomas

  • Study HIC#:2000024688
  • Last Updated:07/15/2021

Brief Summary:

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 two 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

  • Start Date05/28/2020
  • End Date09/30/2021

Trial Purpose and Description

Primary Outcome Measures  :

  1. Dose Escalation Period: Number of participants with dose-limiting toxicities (DLTs) [ Time Frame: within 28 days after the initial dose of the study drug ]Number of DLT-evaluable participants with protocol-defined DLTs
  2. Dose Escalation Period: Maximum concentration (Cmax) of DS-3201 [ Time Frame: within the first 28-day cycle ]Categories: Cycle 1 Day 1, Cycle 1 Day 15
  3. Dose Escalation Period: Time of maximum concentration (Tmax) of DS-3201 [ Time Frame: within the first 28-day cycle ]Categories: Cycle 1 Day 1, Cycle 1 Day 15
  4. Dose Escalation Period: Area under the plasma concentration time curve up to the last quantifiable time (AUClast) for DS-3201 [ Time Frame: Day 1 of the first 28-day cycle ]
  5. Dose Escalation Period: Area under the plasma concentration time curve during the dosing interval (AUCtau) for DS-3201 [ Time Frame: Day 1 of the first 28-day cycle ]
  6. Dose Escalation Period: Trough (minimum) plasma concentration (Ctrough) [ Time Frame: Day 15 of the first 28-day cycle ]
  7. Dose Escalation Period: Average plasma concentration (Cavg) [ Time Frame: Day 15 of the first 28-day cycle ]
  8. Number of participants with malignant lymphoma who achieved each level of therapeutic response per international consensus standards [ Time Frame: through the end of the study (within approximately 5 years) ]Categories: Complete remission (CR), Partial remission (PR), Stable disease (SD), Relapsed disease or progressive disease (RD/PD)
  9. Number of participants with ATL who achieved each level of therapeutic response per international consensus standards [ Time Frame: through the end of the study (within approximately 5 years) ]Categories: CR, Uncertified complete remission (CRu), PR, SD, RD/PD, Unassessable (UA)
  10. Number of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: through the end of the study (within approximately 5 years) ]TEAEs are systematically collected from lab values, physical exams, and other investigations

Secondary Outcome Measures  :

  1. Best overall response, based on international consensus criteria [ Time Frame: from the start of study treatment to the end of follow-up visit (within 5 years) ]

    Best overall response is defined as the percentage of participants who achieved each category as the best response, considering all overall responses assessed at all time points after the start of study treatment.

    Categories: CR, CRu, PR, SD, RD/PD, UA

    Categories: Malignant lymphoma, ATL

  2. Objective response rate (ORR) [ Time Frame: within 5 years ]ORR is defined as the percentage of participants who were assessed for best overall response, who achieved CR, UCR, or PR
  3. Disease control rate (DCR) [ Time Frame: within 5 years ]DCR is defined as the percentage of participants who were assessed for best overall response, who achieved a best response of CR, UCR, PR, or SD

Eligibility Criteria

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
  • 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

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
  • Lives in the United States, and is willing to provide:
    1. archived or fresh tumor tissue samples that are sufficient for comprehensive genomic and/or proteomic analyses at baseline
    2. fresh on-treatment tumor biopsy if deemed acceptable risk by the investigator
    3. optional fresh end-of-treatment biopsy

Exclusion Criteria:

  • Has been diagnosed with protocol-defined cutaneous T-cell lymphoma or T-cell leukemia
  • 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

For more information about this study, contact:

Or contact the Help us Discover team on: