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

NCT07444268 | Recruiting Phase 1 FDA Drug

• 1 other identifier: DSP-5336-102
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Advanced Hematologic Malignancies

Outcome Measures

Primary Outcomes (4)

• Total recovery of radioactivity in urine as percentage of total radioactive dose of [14C]-DSP-5336

  The percentage of dose excreted in urine

  Day 1 to 4, max 7 days if less than 90% is collected by Day 4

• Total recovery of radioactivity in fecal waste as percentage of total radioactive dose of [14C]-DSP-5336

  The percentage of dose excreted in fecal waste

  Day 1 to 4, max 7 days if less than 90% is collected by Day 4

• Total recovery of radioactivity in excreta balance as percentage of total radioactive dose of [14C]-DSP-5336

  The percentage of dose excreted in combined urine and fecal waste

  Day 1 to 4, max 7 days if less than 90% is collected by Day 4

• Relative abundance (mean value) of [14C]-DSP-5336

  Plasma samples will be analyzed for \[14C\]-DSP-5336 and its metabolites.

  4 days, max 7 days

Secondary Outcomes (5)

• Area under the plasma concentration time profile from time zero to time of the last quantifiable concentration (AUClast) of [14C]-DSP-5336

  4 days, max 7 days

• Cmax for the relative bioavailability of [14C]-DSP-5336

  4 days, max 7 days

• t(1/2) of [14C]-DSP-5336

  4 days, max 7 days

• Ratio of plasma to whole blood total radioactivity

  4 days, max 7 days

• Number of participants with adverse events and serious adverse events

  30 days

Study Arms (2)

DSP-5336 tablets and [14C]-DSP-5336 solution

EXPERIMENTAL

Part 1

Drug: DSP-5336; Drug: [14C]-DSP-5336

Optional Continued Access

EXPERIMENTAL

Part 2

Drug: DSP-5336

Interventions

DSP-5336 DRUG

tablet

DSP-5336 tablets and [14C]-DSP-5336 solution; Optional Continued Access

[14C]-DSP-5336 DRUG

oral solution

DSP-5336 tablets and [14C]-DSP-5336 solution

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male, female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, of any race, ≥ 18 years of age. Female patients must be surgically sterile or postmenopausal. Male patients must be permanently sterile or agree to use contraception.
• Have an advanced hematological malignancy that is relapsed, refractory, or has progressed following receipt of standard and available treatments.
• Any prior pre-treatment toxicities resolved to ≤Grade 1 prior to enrolment, with exception of ≤Grade 2 alopecia or neuropathy.
• Adequate kidney and liver function
• ECOG performance status of ≤ 2.
• Able to attend the required study visits, including the confinement period for monitoring and collection of bowel movements and micturition.
• Able to comprehend and are willing to sign the ICF and abide by the study restrictions.

You may not qualify if:

• Histologic diagnosis of acute promyelocytic leukemia.
• Abnormal ECG that is clinically significant, such as QTcF \> 480 msec. QT interval correction can be performed in the case of bundle branch block.
• History of torsades de pointes.
• Left ventricular ejection fraction ≤ 45%, as determined by echocardiogram.
• Have any concurrent conditions that could pose an undue risk or interfere with interpretation of the study results, including, but not limited to clinically significant non-healing or healing wounds, concurrent congestive heart failure, unstable angina, cardiac arrhythmia requiring treatment (excluding asymptomatic atrial fibrillation), myocardial infarction within 6 months, acute coronary syndrome within 6 months, significant pulmonary disease (shortness of breath at rest or on mild exertion; eg, due to concurrent severe obstructive pulmonary disease, hypertension not controlled with concomitant medication, or diabetes mellitus with \> 2 episodes of ketoacidosis in the prior 6 months).
• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed).
• History or evidence of severe dysphagia, short-gut syndrome, gastroparesis, gastrointestinal tract disease, malabsorption syndrome, the requirement for intravenous alimentation, gastric/jejunal feeds, any uncontrolled gastrointestinal disease, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally, including the inability to swallow oral medication
• Have cognitive, psychological, or psychosocial impediment that would impair their ability to receive therapy according to the protocol or would adversely affect their ability to comply with the informed consent process, protocol, or protocol-required visits and procedures.
• History of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of check-in, unless approved by the investigator and medical monitor.
• Active and uncontrolled bacterial, viral, or fungal infection requiring parenteral therapy.
• Positive hepatitis panel and/or positive human immunodeficiency virus test indicative of active infection. Patients whose results are compatible with prior immunization may be included.
• Undergone HSCT, chimeric antigen receptor cell therapy, or other modified T-cell therapy within 60 days prior to dosing.
• Received donor lymphocyte infusion within 28 days prior to dosing, receiving immunosuppressive therapy post-HSCT, or have clinically active GVHD or GVHD requiring active medical intervention other than the use of topical steroids for ongoing cutaneous GVHD.
• Received systemic calcineurin inhibitors within 2 weeks prior to dosing.
• Received other anticancer drugs or other investigational treatment within 14 days or 5 half-lives, whichever is shorter, prior to dosing.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (2)

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

NOT YET RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Central Study Contacts

Holly Beever

CONTACT

774-405-5261; holly.beever@us.sumitomo-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: March 2, 2026
• Study Start: March 26, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)