The purpose of this study is to evaluate the safety, tolerability and drug levels of Navlimetostat (BMS-986504) in participants with advanced solid tumors.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
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
Trial sites (12)
Facility
City
Region
Status
Beijing Cancer hospital
Beijing
Beijing Municipality
Recruiting
Fujian Cancer Hospital
Fuzhou
Fujian
Recruiting
Guangdong Provincial People's Hospital
Guangzhou
Guangdong
Recruiting
Peking University Shenzhen Hospital
Shenzhen
Guangdong
Recruiting
Harbin Medical University Cancer Hospital
Harbin
Heilongjiang
Recruiting
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang
Henan
Recruiting
Shandong Cancer Hospital
Jinan
Shandong
Recruiting
Tianjin Medical University Cancer Institute & Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.