New drug metabolism study launches for stubborn blood cancers
NCT ID NCT07444268
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how the body absorbs, breaks down, and gets rid of an experimental drug called DSP-5336. It involves 8 adults with advanced blood cancers (like leukemia or myeloma) that no longer respond to standard treatments. Participants take a single radioactive-labeled pill, and researchers measure the drug in blood, urine, and stool. The goal is only to understand the drug's path through the body, not to treat the cancer.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 8 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2026
- Expected to finish
-
Aug 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute leukemia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
2 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Locations
-
MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
-
University of North Carolina
NOT_YET_RECRUITINGChapel Hill, North Carolina, 27514, United States
Contact Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Platelet-Boosting drug help control a rare bone marrow disorder?
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas
- Banking blood and bone marrow to decode plasma cell disorders