Advanced Solid Tumors With Homozygous MTAP DeletionPhase 1NCT06672523
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
A Phase 1 study testing BMS-986504 and [14C]-BMS-986504 in people with Advanced Solid Tumors With Homozygous MTAP Deletion, run by Bristol-Myers Squibb at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors With Homozygous MTAP Deletion
- What is being tested?
- BMS-986504 and [14C]-BMS-986504
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 24 Mar 2025to 25 Oct 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
3 sites in 2 countries
Spain2 sites, 2 recruiting
- Recruiting
START Rioja, The START Center for cancer research
Logroño, 26006
Maria De Miguel, Site 0004, +34955013068
- Recruiting
Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid,
Madrid, 28050
Irene Moreno Candilejo, Site 0003, 917567800
Hungary1 site, 1 recruiting
- Recruiting
ICON / PRA Magyarország Kft. Fázis I-es Klinikai Farmakológiai Vizsgálóhely
Budapest, 1076
Zsuzsanna Papai, Site 0001, +36308281059
About this study
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
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.
- Being tested
- BMS-986504, [14C]-BMS-986504
- 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)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986504Drug
Specified dose on specified days
[14C]-BMS-986504Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| [14C]-BMS-986504 followed by BMS-986504 Monotherapy | Experimental | Part A: Participants will receive a single oral dose of radiolabeled [14C]-BMS-986504 on C1D1.
Part B: Participants will receive non-radiolabeled BMS-986504, starting from C1D1 and until criteria for treatment discontinuation are met. Receives: Drug: BMS-986504; Drug: [14C]-BMS-986504 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax)
Measured: Up to 2 weeks
Time of maximum observed drug concentration (Tmax)
Measured: Up to 2 weeks
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Measured: Up to 2 weeks
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Measured: Up to 2 weeks
Terminal elimination half-life (T-HALF)
Measured: Up to 2 weeks
Apparent total body clearance (CLT/F)
Measured: Up to 2 weeks
Apparent volume of distribution during the terminal phase (Vz/F)
Measured: Up to 2 weeks
Percentage of estimated part for the calculation of AUC(INF) (%AUC(INF))
Measured: Up to 2 weeks
Blood-to-plasma total radioactivity (TRA) ratio
Measured: Up to 2 weeks
Total amount of administered dose recovered in urine (UR)
Measured: Up to 2 weeks
Percent of administered dose recovered in urine (%UR)
Measured: Up to 2 weeks
Renal clearance (CLR) in urine
Measured: Up to 2 weeks
Total radioactivity in UR
Measured: Up to 2 weeks
Total radioactivity in %UR
Measured: Up to 2 weeks
Total radioactivity in total amount of administered dose recovered in feces (FR)
Measured: Up to 2 weeks
Total radioactivity in percent of administered dose recovered in feces (%FR)
Measured: Up to 2 weeks
Total amount of radioactivity recovered (Rtotal)
Measured: Up to 2 weeks
Total percent of radioactivity recovered (%TOTAL)
Measured: Up to 2 weeks
TRA amount recovered and fraction of the radioactive dose in vomit if applicable
Measured: Up to 2 weeks
Secondary outcomes (6)
Number of participants with adverse events (AEs)
Measured: Up to 2 years
Number of participants with serious adverse events (SAEs)
Measured: Up to 2 years
Number of participants with AEs leading to discontinuation
Measured: Up to 2 years
Number of participants with drug-related AEs
Measured: Up to 2 years
Number of participants with laboratory abnormalities
Measured: Up to 2 years
Number of deaths
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start24 Mar 2025
- Primary completion25 Oct 2027 (estimated)
- Study completion25 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumors With Homozygous MTAP DeletionStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672523
- Sponsor's protocol ID
- CA240-0008
- Status last verified
- Jun 2026
- First submitted
- 1 Nov 2024
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06672523
- Acronym / sponsor ID
- CA240-0008
- Keywords
- Protein arginine methyltransferase (PRMT5), Methylthioadenosine-cooperative PRMT5 inhibitor, Homozygous methylthioadenosine phosphorylase (MTAP) deletion, Mass balance study, Metabolism, Elimination, Drug absorption, Distribution
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 25 Oct 2027 (estimated)
- Study completion
- 25 Oct 2027 (estimated)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-BMS-986504 followed by BMS-986504 Monotherapy | Experimental | Drug: BMS-986504, Drug: [14C]-BMS-986504Part A: Participants will receive a single oral dose of radiolabeled [14C]-BMS-986504 on C1D1. Part B: Participants will receive non-radiolabeled BMS-986504, starting from C1D1 and until criteria for treatment discontinuation are met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986504Specified dose on specified days | Drug | [14C]-BMS-986504 followed by BMS-986504 Monotherapy |
| [14C]-BMS-986504Specified dose on specified days | Drug | [14C]-BMS-986504 followed by BMS-986504 Monotherapy |
Primary outcome
Maximum observed concentration (Cmax)
Time frame: Up to 2 weeks
Time of maximum observed drug concentration (Tmax)
Time frame: Up to 2 weeks
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Time frame: Up to 2 weeks
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to 2 weeks
Terminal elimination half-life (T-HALF)
Time frame: Up to 2 weeks
Apparent total body clearance (CLT/F)
Time frame: Up to 2 weeks
Apparent volume of distribution during the terminal phase (Vz/F)
Time frame: Up to 2 weeks
Percentage of estimated part for the calculation of AUC(INF) (%AUC(INF))
Time frame: Up to 2 weeks
Blood-to-plasma total radioactivity (TRA) ratio
Time frame: Up to 2 weeks
Total amount of administered dose recovered in urine (UR)
Time frame: Up to 2 weeks
Percent of administered dose recovered in urine (%UR)
Time frame: Up to 2 weeks
Renal clearance (CLR) in urine
Time frame: Up to 2 weeks
Total radioactivity in UR
Time frame: Up to 2 weeks
Total radioactivity in %UR
Time frame: Up to 2 weeks
Total radioactivity in total amount of administered dose recovered in feces (FR)
Time frame: Up to 2 weeks
Total radioactivity in percent of administered dose recovered in feces (%FR)
Time frame: Up to 2 weeks
Total amount of radioactivity recovered (Rtotal)
Time frame: Up to 2 weeks
Total percent of radioactivity recovered (%TOTAL)
Time frame: Up to 2 weeks
TRA amount recovered and fraction of the radioactive dose in vomit if applicable
Time frame: Up to 2 weeks
6 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Up to 2 years
Number of participants with serious adverse events (SAEs)
Time frame: Up to 2 years
Number of participants with AEs leading to discontinuation
Time frame: Up to 2 years
Number of participants with drug-related AEs
Time frame: Up to 2 years
Number of participants with laboratory abnormalities
Time frame: Up to 2 years
Number of deaths
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986504 and [14C]-BMS-986504 in people with Advanced Solid Tumors With Homozygous MTAP Deletion, run by Bristol-Myers Squibb at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed concentration (Cmax) (time frame: Up to 2 weeks). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.