Phase
Condition
Neoplasms
Solid Tumors
Treatment
[14C] Subasumstat
Subasumstat
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Participants have histologically or cytologically confirmed advanced (locallyregionally recurrent not amenable to curative therapy) or metastatic solid tumorswith no standard therapeutic option with a proven clinical benefit, are intolerantor have refused them.
Participants have a performance status of 0 or 1 on the Eastern Cooperative OncologyGroup Performance Scale.
Participants demonstrate adequate organ function.
Participants have recovered to Grade 1 or baseline from all toxicity associated withprevious therapy or have the toxicity established as sequela.
Exclusion
Key Exclusion Criteria:
Participants received treatment with radioisotopes within 5 half-lives before thefirst dose of the study drug.
Participants received radiolabelled substances, were exposed to radiation sourceswithin 12 months of the first dose in this study, or is likely to receive radiationexposure or radioisotopes within 12 months of the first dose in this study such thatparticipation in this study would increase their total exposure beyond therecommended safe levels.
Participants received extended field radiotherapy ≤4 weeks before the start oftreatment.
Participants have uncontrolled brain metastasis. Participants with treated brainmetastases are allowed provided they are radiologically stable, without evidence ofprogression for at least 4 weeks by repeat imaging, clinically stable, and withoutrequirement of steroid treatment for at least 14 days before first dose of studytreatment.
Participants had a second malignancy within the previous 3 years, except treatedbasal cell or localized squamous skin carcinomas, prostate cancer, cervicalcarcinoma in situ, resected colorectal adenomatous polyps, breast cancer in situ, orother malignancy for which the patient is not on active anticancer therapies.
Major surgery ≤14 days from the first dose of study drug and not recovered fullyfrom any complications from surgery.
Baseline prolongation of the QT interval when corrected using Fridericia's formula (QTcF).
Receiving or requires the continued use of medications that are known to be strongor moderate inhibitors and inducers of cytochrome P450 (CYP) 3A4/5 and strongP-glycoprotein (Pgp) inhibitors.
Has active noninfectious pneumonitis or interstitial lung disease that requiredsteroids.
History of allogeneic tissue or solid organ transplant.
Participants have active bacterial infection requiring systemic therapy <14 daysbefore the start of treatment.
Participants have an active HIV or any other relevant congenital or acquiredimmunodeficiency.
Active hepatitis B, or hepatitis C infection.
Any of the following uncontrolled heart diseases: congestive heart failure New YorkHeart Association Grade III or IV, unstable angina, myocardial infarction, unstablesymptomatic ischemic heart disease, uncontrolled hypertension despite appropriatemedical therapy, ongoing symptomatic cardiac arrhythmias >Grade 2, pulmonaryembolism or symptomatic cerebrovascular events, or any other serious cardiaccondition (eg, pericardial effusion or restrictive cardiomyopathy). Chronic atrialfibrillation on stable anticoagulant therapy is allowed.
Study Design
Study Description
Connect with a study center
Central Hospital of Northern Pest - Military Hospital
Budapest, 1062
HungarySite Not Available
Pharmaceutical Research Associates Magyarorszag
Budapest, 1077
HungarySite Not Available
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