DS-3201b in Participants With Lymphomas

• Status: Recruiting
• Trial end date: 2024-07-31
• Target enrollment: 0
• Participant gender: All

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 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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Co., Ltd.
• Collaborator: Daiichi Sankyo, Inc.

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 (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