DSP-5336 Absorption Study for Advanced Blood Cancers
This study is looking at how a drug called DSP-5336 is absorbed, broken down, and removed from your body. You would receive a single dose of DSP-5336, either as a tablet or an oral solution. Researchers will then measure how much of the drug leaves your body through urine and stool over several days. This helps them understand how the drug works in people with advanced blood cancers (hematologic malignancies) that have not responded to other treatments. The study is looking for 8 participants and the current status is unclear.
- Study design
- This is an interventional study involving 8 participants. It is not specified if it is randomized or blinded.
- What's involved
- You would receive a single oral dose of DSP-5336. Researchers would then collect urine and stool samples for up to 7 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed for up to 7 days after receiving the dose to collect urine and fecal samples.
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NCT07444268
How [14C]-DSP-5336 is Absorbed, Broken Down, and Removed From the Body After a Single Oral Dose in Patients With Advanced Blood Cancers
Recruiting
PHASE1Ages 18+InterventionalTreatmentSumitomo Pharma America, Inc.
~8 participants
Updated 2026-04-08 on ClinicalTrials.gov
What's tested:DSP-5336[14C]-DSP-5336
At a glance
Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Total recovery of radioactivity in urine as percentage of total radioactive dose of [14C]-DSP-5336
Measured over Day 1 to 4, max 7 days if less than 90% is collected by Day 4
+3 more outcomes measured
Conditions
Where it's being run
2 sites across 2 statesNorth Carolina1
Texas1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
Exclusion
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.
Major surgery within 28 days prior to dosing.
Any known intolerance or hypersensitivity to components of the study intervention.
Patients who have previously been dosed in \> 2 radiolabeled drug studies in the last 12 months. For patients who have previously been dosed in ≤ 2 radiolabeled drug studies within the last 12 months, the previous radiolabeled dose must be at least 4 months prior to check-in to the study site where exposures are known to the investigator or 6 months prior to check-in to the study site for a radiolabeled drug study where exposures are not known to the investigator.
Poor peripheral venous access.
Patients with exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
Patients who, in the opinion of the investigator or designee, should not participate in this study.
What this trial measures
- Total recovery of radioactivity in urine as percentage of total radioactive dose of [14C]-DSP-5336Day 1 to 4, max 7 days if less than 90% is collected by Day 4
The percentage of dose excreted in urine
- Total recovery of radioactivity in fecal waste as percentage of total radioactive dose of [14C]-DSP-5336Day 1 to 4, max 7 days if less than 90% is collected by Day 4
The percentage of dose excreted in fecal waste
- Total recovery of radioactivity in excreta balance as percentage of total radioactive dose of [14C]-DSP-5336Day 1 to 4, max 7 days if less than 90% is collected by Day 4
The percentage of dose excreted in combined urine and fecal waste
- Relative abundance (mean value) of [14C]-DSP-53364 days, max 7 days
Plasma samples will be analyzed for \[14C\]-DSP-5336 and its metabolites.