How [14C]-DSP-5336 is Absorbed, Broken Down, and Removed From the Body After a Single Oral Dose in Patients With Advanced Blood Cancers

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
Sumitomo Pharma America, Inc.
Study ID
NCT07444268
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Hematologic Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DSP-5336 — DRUG
    tablet
  • [14C]-DSP-5336 — DRUG
    oral solution

Study Details

The purpose of this study is to evaluate the absorption, metabolism, and excretion of DSP-5336 following a single oral administration of the study drug in patients with hematologic malignancies whose disease has progressed after available standard therapies.

Key Dates

Start date
Mar 26, 2026
Status verified
Apr 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
8 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: DSP-5336 tablets and [14C]-DSP-5336 solution
    Part 1
  • Experimental: Optional Continued Access
    Part 2

Primary Outcome Measure

Total recovery of radioactivity in urine as percentage of total radioactive dose of [14C]-DSP-5336 [ Time Frame: Day 1 to 4, max 7 days if less than 90% is collected by Day 4 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of North CarolinaChapel HillNorth Carolina27514
Joshua Zeidner, MD
[email protected]
919-966-4432
MD Anderson Cancer CenterHoustonTexas77030
Naval Daver, MD
[email protected]
713-794-4392

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By research site
University of North Carolina· Chapel Hill, NCMD Anderson Cancer Center· Houston, TX