Recruiting NCT07077434
A Study to Assess Safety, Tolerability and Drug Levels of Navlimetostat (BMS-986504) in Participants With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BMS-986504.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China, Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase 1 Open-Label, Multi-Center Study to Evaluate Pharmacokinetics, Safety and Tolerability of Navlimetostat (BMS-986504) in Japanese and Chinese Participants With Advanced Solid Tumors With Homozygous MTAP Deletion
Overview
The purpose of this study is to evaluate the safety, tolerability and drug levels of Navlimetostat (BMS-986504) in participants with advanced solid tumors.
Interventions
- Drug BMS-986504
Specified dose on specified days
Primary outcome measures
- Maximum Plasma Concentration (Cmax) of BMS-986504 [Time frame: Up to approximately Day 64]
- Time to Reach Maximum Plasma Concentration (Tmax) of BMS-986504 [Time frame: Up to approximately Day 64]
- Area Under Curve (AUC) of BMS-986504 [Time frame: Up to approximately Day 64]
- Mean Elimination Half-life (T-HALF) of BMS-986504 [Time frame: Up to approximately Day 64]
- Apparent Total Body Clearance (CLT/F) of BMS-986504 [Time frame: Up to approximately Day 64]
- Apparent Volume of Distribution During the Terminal Phase (Vz/F) of BMS-986504 [Time frame: Up to approximately Day 64]
Secondary outcome measures (10)
- Number of Participants With Dose-limiting Toxicities (DLTs) [Time frame: Up to approximately Day 25]
- Number of Participants With Treatment-related Adverse Events (AE) [Time frame: Up to approximately 28 days after last dose of BMS-986504]
- Number of Participants With all-cause AEs [Time frame: Up to approximately 28 days after last dose of BMS-986504]
- Number of Participants With Treatment-related Serious AEs (SAEs) [Time frame: Up to approximately 28 days after last dose of BMS-986504]
- Number of Participants With all-cause SAEs [Time frame: Up to approximately 28 days after last dose of BMS-986504]
- Number of Participants With AEs Leading to Dose Interruption [Time frame: Up to approximately 28 days after last dose of BMS-986504]
- Number of Participants With AEs Leading to Dose Reduction [Time frame: Up to approximately 28 days after last dose of BMS-986504]
- Number of Participants With AEs Leading to Treatment Discontinuation [Time frame: Up to approximately 28 days after last dose of BMS-986504]
- Number of Participants With AEs Leading to Death [Time frame: Up to approximately 28 days after last dose of BMS-986504]
- Number of Participants With Laboratory Abnormalities [Time frame: Up to approximately 28 days after last dose of BMS-986504]
Eligibility criteria
Inclusion criteria
- Participants must have histologically confirmed diagnosis of a solid tumor malignancy with homozygous MTAP deletion or MTAP loss detected in tumor tissue by a Sponsor-provided central test or a Sponsor pre-approved local test.
- 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/Exclusion criteria apply.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 8 centers
- Beijing Cancer hospital — Beijing
- Fujian Cancer Hospital — Fuzhou
- Guangdong Provincial People's Hospital — Guangzhou
- Peking University Shenzhen Hospital — Shenzhen
- Harbin Medical University Cancer Hospital — Harbin
- The First Affiliated Hospital of Xinxiang Medical University — Xinxiang
- Shandong Cancer Hospital — Jinan
- Tianjin Medical University Cancer Institute & Hospital — Tianjin
Japan · 4 centers
- Kanagawa cancer center — Yokohama
- Shizuoka Cancer Center — Sunto-gun
- National Cancer Center Hospital — Chuo-ku
- The Cancer Institute Hospital of JFCR — Koto-ku
Identifiers
NCT: NCT07077434 · CA240-0010