Advanced Solid Tumors
Conditions
Keywords
MTAP, PRMT5, MRTX1719, CDKN2A
Brief summary
The purpose of this study is to evaluate the safety, tolerability and drug levels of BMS-986504 in participants with advanced solid tumors.
Interventions
DRUGBMS-986504
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must have histologically confirmed diagnosis of a solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue. * Participants must have unresectable or metastatic disease not amenable to curative therapies after progression on prior therapies at the time of enrollment. * Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Participants must have presence of at least one measurable tumor lesion per RECIST 1.1 at baseline.
Exclusion criteria
* Participants must not have prior treatment with a Protein arginine methyltransferase 5 (PRMT5) or Methionine adenosyltransferase 2A (MAT2A) inhibitor. * Participants must not have active brain metastases or carcinomatous meningitis. * Participants must not have a history of gastrointestinal disease or other gastrointestinal conditions (e.g., uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications. * Participants must not have known severe hypersensitivity to study treatment and/or any of its excipients. * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Plasma Concentration (Cmax) of BMS-986504 | Up to approximately Day 64 |
| Time to Reach Maximum Plasma Concentration (Tmax) of BMS-986504 | Up to approximately Day 64 |
| Area Under Curve (AUC) of BMS-986504 | Up to approximately Day 64 |
| Mean Elimination Half-life (T-HALF) of BMS-986504 | Up to approximately Day 64 |
| Apparent Total Body Clearance (CLT/F) of BMS-986504 | Up to approximately Day 64 |
| Apparent Volume of Distribution During the Terminal Phase (Vz/F) of BMS-986504 | Up to approximately Day 64 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With AEs Leading to Dose Reduction | Up to approximately 28 days after last dose of BMS-986504 |
| Number of Participants With AEs Leading to Treatment Discontinuation | Up to approximately 28 days after last dose of BMS-986504 |
| Number of Participants With Dose-limiting Toxicities (DLTs) | Up to approximately Day 25 |
| Number of Participants With Laboratory Abnormalities | Up to approximately 28 days after last dose of BMS-986504 |
| Number of Participants With AEs Leading to Death | Up to approximately 28 days after last dose of BMS-986504 |
| Number of Participants With Treatment-related Adverse Events (AE) | Up to approximately 28 days after last dose of BMS-986504 |
| Number of Participants With all-cause AEs | Up to approximately 28 days after last dose of BMS-986504 |
| Number of Participants With Treatment-related Serious AEs (SAEs) | Up to approximately 28 days after last dose of BMS-986504 |
| Number of Participants With all-cause SAEs | Up to approximately 28 days after last dose of BMS-986504 |
| Number of Participants With AEs Leading to Dose Interruption | Up to approximately 28 days after last dose of BMS-986504 |
Countries
China, Japan
Contacts
Primary ContactBMS Study Connect Contact Center, www.BMSStudyConnect.com
Backup ContactFirst line of the email MUST contain the NCT# and Site #.
Outcome results
None listed