An Absorption, Distribution, Metabolism, Excretion (ADME) Study of [14C]Subasumstat in Adults Wit… (NCT05976334) | Clinical Trial Compass
TerminatedPhase 1
An Absorption, Distribution, Metabolism, Excretion (ADME) Study of [14C]Subasumstat in Adults With Advanced or Metastatic Solid Tumors
Stopped: Business reasons
Hungary3 participantsStarted 2023-11-14
Plain-language summary
The main aim of this study is to assess how the human body of adults with advanced or metastatic solid tumors absorbs, distributes, metabolizes and excretes subasumstat following a single 1 hour infusion of subasumstat.
The study consists of two parts. In Part A, participants will receive a single infusion of C14 radiolabeled subasumstat. In Part B, participants will receive subasumstat treatment for up to 1 year.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Participants have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale.
✓. Participants demonstrate adequate organ function.
✓. Participants have recovered to Grade 1 or baseline from all toxicity associated with previous therapy or have the toxicity established as sequela.
Exclusion criteria
✕. Participants received treatment with radioisotopes within 5 half-lives before the first dose of the study drug.
✕. 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.
✕. Participants received extended field radiotherapy ≤4 weeks before the start of treatment.
What they're measuring
1
Cumulative Percentage of Urinary Recovery
Timeframe: Up to 14 days post-dose
2
Cumulative Percentage of Fecal Recovery
Timeframe: Up to 14 days post-dose
3
Cumulative Percentage of Combined Recovery
Timeframe: Up to 14 days post-dose
4
Percentage Of Recovered Total Radioactivity (TRA) In Urine
Timeframe: Post-dose Day 1: 0-6 hours (hr), 6-12 hr, Day 2: 12-24 hr, Day 3: 24-48 hr, Day 4: 48-72, Day 5: 72-96 hr, Day 6: 96-120 hr, Day 7: 120-144 hr, Day 8: 144-168 hr, Day 9: 168-192 hr, Day 10: 192-216 hr, Day 11: 216-240 hr, Day 12: 240-264 hr
5
Percentage Of Recovered Total Radioactivity (TRA) In Feces
Timeframe: Post-dose Day 1: 0-6 hours hr, 6-12 hr, Day 2: 12-24 hr, Day 3: 24-48 hr, Day 4: 48-72 hr, Day 5: 72-96 hr, Day 6: 96-120 hr, Day 7: 120-144 hr, Day 8: 144-168 hr, Day 9: 168-192 hr, Day 10: 192-216 hr, Day 11: 216-240 hr
✕. 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.
✕. 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.
✕. Major surgery ≤14 days from the first dose of study drug and not recovered fully from 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 strong or moderate inhibitors and inducers of cytochrome P450 (CYP) 3A4/5 and strong P-glycoprotein (Pgp) inhibitors.