Clinical trial NCT06672523: A Study to Evaluate the Mass Balance, Metabolism, Elimination, and Drug Levels of [14C]-BMS-986504 (MRTX1719) in Participants With Advanced Solid Tumors With Homozygous Methylthioadenosine Phosphorylase Deletion
Official title: A Phase 1 Study to Evaluate the Mass Balance, Metabolism, Excretion, and Pharmacokinetics of [14C]-BMS-986504 (MRTX1719) in Patients With Advanced Solid Tumors With Homozygous MTAP Deletion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors With Homozygous MTAP Deletion
Keywords: Protein arginine methyltransferase (PRMT5)
Methylthioadenosine-cooperative PRMT5 inhibitor
Homozygous methylthioadenosine phosphorylase (MTAP) deletion
Mass balance study
Metabolism
Elimination
Drug absorption
Distribution
Excretion
Radiolabeled
Absorption, distribution, metabolism, and excretion (ADME)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-11-04
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the mass balance, metabolism, elimination, and drug levels of \[14C\]-BMS-986504 (MRTX1719) in participants with advanced solid tumors with homozygous methylthioadenosine phosphorylase deletion.


Eligibility criteria: Inclusion Criteria

* Participants must have an advanced, unresectable, or metastatic solid tumor malignancy with a deletion of the methylthioadenosine phosphorylase (MTAP) gene.
* Participants must have received, be refractory to, be ineligible for, or be intolerant of available standard care for their cancer.

Exclusion Criteria

* Participants must not have a history of any surgical or medical conditions possibly affecting how the study drug is distributed, broken down (metabolized) and removed (excreted or eliminated) from the body.
* Participants must not have participated in a clinical study involving a radiolabeled study drug within 12 months prior to admission to the research center.
* Participants must not have a current or recent (within 3 months of study drug administration) gastrointestinal disease.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcomes:
measure: Maximum observed concentration (Cmax)
timeFrame: Up to 2 weeks
measure: Time of maximum observed drug concentration (Tmax)
timeFrame: Up to 2 weeks
measure: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
timeFrame: Up to 2 weeks
measure: Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
timeFrame: Up to 2 weeks
measure: Terminal elimination half-life (T-HALF)
timeFrame: Up to 2 weeks
measure: Apparent total body clearance (CLT/F)
timeFrame: Up to 2 weeks
measure: Apparent volume of distribution during the terminal phase (Vz/F)
timeFrame: Up to 2 weeks
measure: Percentage of estimated part for the calculation of AUC(INF) (%AUC(INF))
timeFrame: Up to 2 weeks
measure: Blood-to-plasma total radioactivity (TRA) ratio
timeFrame: Up to 2 weeks
measure: Total amount of administered dose recovered in urine (UR)
timeFrame: Up to 2 weeks
measure: Percent of administered dose recovered in urine (%UR)
timeFrame: Up to 2 weeks
measure: Renal clearance (CLR) in urine
timeFrame: Up to 2 weeks
measure: Total radioactivity in UR
timeFrame: Up to 2 weeks
measure: Total radioactivity in %UR
timeFrame: Up to 2 weeks
measure: Total radioactivity in total amount of administered dose recovered in feces (FR)
timeFrame: Up to 2 weeks
measure: Total radioactivity in percent of administered dose recovered in feces (%FR)
timeFrame: Up to 2 weeks
measure: Total amount of radioactivity recovered (Rtotal)
timeFrame: Up to 2 weeks
measure: Total percent of radioactivity recovered (%TOTAL)
timeFrame: Up to 2 weeks
measure: TRA amount recovered and fraction of the radioactive dose in vomit if applicable
timeFrame: Up to 2 weeks
Secondary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 2 years
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to 2 years
measure: Number of participants with AEs leading to discontinuation
timeFrame: Up to 2 years
measure: Number of participants with drug-related AEs
timeFrame: Up to 2 years
measure: Number of participants with laboratory abnormalities
timeFrame: Up to 2 years
measure: Number of deaths
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: ICON / PRA Magyarország Kft. Fázis I-es Klinikai Farmakológiai Vizsgálóhely
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: