Early study on cancer drug subasumstat stopped short
NCT ID NCT05976334
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how adults with advanced or metastatic solid tumors absorb, break down, and remove the drug subasumstat. Only 3 people took part, and the study was stopped early. The goal was to measure the drug in urine and stool, not to test if it works as a treatment.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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3 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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Jul 2024
- Lead sponsor
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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
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Anyone
- Healthy volunteers
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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.
Key Inclusion Criteria: 1. Participants have histologically or cytologically confirmed advanced (locally regionally recurrent not amenable to curative therapy) or metastatic solid tumors with no standard therapeutic option with a proven clinical benefit, are intolerant or have refused them. 2. Participants have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale. 3. Participants demonstrate adequate organ function. 4. Participants have recovered to Grade 1 or baseline from all toxicity associated with previous therapy or have the toxicity established as sequela. Key Exclusion Criteria: 1. Participants received treatment with radioisotopes within 5 half-lives before the first dose of the study drug. 2. Participants received radiolabelled substances, were exposed to radiation sources within 12 months of the first dose in this study, or is likely to receive radiation exposure or radioisotopes within 12 months of the first dose in this study such that participation in this study would increase their total exposure beyond the recommended safe levels. 3. Participants received extended field radiotherapy ≤4 weeks before the start of treatment. 4. Participants have uncontrolled brain metastasis. Participants with treated brain metastases are allowed provided they are radiologically stable, without evidence of progression for at least 4 weeks by repeat imaging, clinically stable, and without requirement of steroid treatment for at least 14 days before first dose of study treatment. 5. Participants had a second malignancy within the previous 3 years, except treated basal cell or localized squamous skin carcinomas, prostate cancer, cervical carcinoma in situ, resected colorectal adenomatous polyps, breast cancer in situ, or other malignancy for which the patient is not on active anticancer therapies. 6. Major surgery ≤14 days from the first dose of study drug and not recovered fully from any complications from surgery. 7. Baseline prolongation of the QT interval when corrected using Fridericia's formula (QTcF). 8. Receiving or requires the continued use of medications that are known to be strong or moderate inhibitors and inducers of cytochrome P450 (CYP) 3A4/5 and strong P-glycoprotein (Pgp) inhibitors. 9. Has active noninfectious pneumonitis or interstitial lung disease that required steroids. 10. History of allogeneic tissue or solid organ transplant. 11. Participants have active bacterial infection requiring systemic therapy \<14 days before the start of treatment. 12. Participants have an active HIV or any other relevant congenital or acquired immunodeficiency. 13. Active hepatitis B, or hepatitis C infection. 14. Any of the following uncontrolled heart diseases: congestive heart failure New York Heart Association Grade III or IV, unstable angina, myocardial infarction, unstable symptomatic ischemic heart disease, uncontrolled hypertension despite appropriate medical therapy, ongoing symptomatic cardiac arrhythmias \>Grade 2, pulmonary embolism or symptomatic cerebrovascular events, or any other serious cardiac condition (eg, pericardial effusion or restrictive cardiomyopathy). Chronic atrial fibrillation on stable anticoagulant therapy is allowed.
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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.
Contacts and locations
Locations
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Central Hospital of Northern Pest - Military Hospital
Budapest, 1062, Hungary
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Pharmaceutical Research Associates Magyarorszag
Budapest, 1077, Hungary
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Other studies related to the condition(s) this trial covers.
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