Advanced Hematologic MalignanciesPhase 1NCT07444268
How [14C]-DSP-5336 is Absorbed, Broken Down, and Removed From the Body After a Single Oral Dose in Patients With Advanced Blood Cancers
A Phase 1 study testing DSP-5336 and [14C]-DSP-5336 in people with Advanced Hematologic Malignancies, run by Sumitomo Pharma America, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Hematologic Malignancies
- What is being tested?
- DSP-5336 and [14C]-DSP-5336
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Mar 2026to 4 Sep 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina
Chapel Hill, North Carolina, 27514
MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of DSP-5336 Following a Single Oral Dose in Patients With Refractory or Relapsed Acute Leukemia, Myelodysplastic Syndrome, Multiple Myeloma, or Myeloproliferative Neoplasms
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
- Being tested
- DSP-5336, [14C]-DSP-5336
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSP-5336Drug
tablet
[14C]-DSP-5336Drug
oral solution
| Study group | Role | What they receive |
|---|---|---|
| DSP-5336 tablets and [14C]-DSP-5336 solution | Experimental | Part 1 Receives: Drug: DSP-5336; Drug: [14C]-DSP-5336 |
| Optional Continued Access | Experimental | Part 2 Receives: Drug: DSP-5336 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total recovery of radioactivity in urine as percentage of total radioactive dose of [14C]-DSP-5336
The percentage of dose excreted in urine
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
The determination of AUClast using the linear/log trapezoidal rule
Measured: 4 days, max 7 days
Cmax for the relative bioavailability of [14C]-DSP-5336
Analysis of the maximum concentration (Cmax) of the relative bioavailability of [14C]-DSP-5336 utilizing the ratio of the adjusted geometric means
Measured: 4 days, max 7 days
t(1/2) of [14C]-DSP-5336
Elimination half-life (t[1/2]) of [14C]-DSP-5336
Measured: 4 days, max 7 days
Ratio of plasma to whole blood total radioactivity
The fraction of [14C]-DSP-5336 radioactivity associated with whole blood and plasma and with red blood cells and other cellular components of whole blood was determined by using the concentration of [14C]-DSP-5336 radioactivity in whole blood and plasma
Measured: 4 days, max 7 days
Number of participants with adverse events and serious adverse events
Safety of DSP-5336 by reporting of AEs and SAEs
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start26 Mar 2026
- Primary completion11 Aug 2026
- Study completion4 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hematologic MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444268
- Sponsor's protocol ID
- DSP-5336-102
- Status last verified
- Sep 2026
- First submitted
- 6 Feb 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of DSP-5336 Following a Single Oral Dose in Patients With Refractory or Relapsed Acute Leukemia, Myelodysplastic Syndrome, Multiple Myeloma, or Myeloproliferative Neoplasms
- ClinicalTrials.gov ID
- NCT07444268
- Acronym / sponsor ID
- DSP-5336-102
- Conditions
- Advanced Hematologic Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- 11 Aug 2026 (actual)
- Study completion
- 4 Sep 2026 (actual)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DSP-5336 tablets and [14C]-DSP-5336 solution | Experimental | Drug: DSP-5336, Drug: [14C]-DSP-5336Part 1 |
| Optional Continued Access | Experimental | Drug: DSP-5336Part 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (21 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DSP-5336tablet | Drug | DSP-5336 tablets and [14C]-DSP-5336 solution, Optional Continued Access |
| [14C]-DSP-5336oral solution | Drug | DSP-5336 tablets and [14C]-DSP-5336 solution |
Primary outcome
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
The percentage of dose excreted in urine
Total recovery of radioactivity in fecal waste 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
The percentage of dose excreted in fecal waste
Total recovery of radioactivity in excreta balance 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
The percentage of dose excreted in combined urine and fecal waste
Relative abundance (mean value) of [14C]-DSP-5336
Time frame: 4 days, max 7 days
Plasma samples will be analyzed for [14C]-DSP-5336 and its metabolites.
5 secondary outcomes
Area under the plasma concentration time profile from time zero to time of the last quantifiable concentration (AUClast) of [14C]-DSP-5336
Time frame: 4 days, max 7 days
Cmax for the relative bioavailability of [14C]-DSP-5336
Time frame: 4 days, max 7 days
t(1/2) of [14C]-DSP-5336
Time frame: 4 days, max 7 days
Ratio of plasma to whole blood total radioactivity
Time frame: 4 days, max 7 days
Number of participants with adverse events and serious adverse events
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DSP-5336 and [14C]-DSP-5336 in people with Advanced Hematologic Malignancies, run by Sumitomo Pharma America, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.