Bristol Myers Squibb Initiates Phase I Clinical Trial of BMS-986504 Tablets in Patients with MTAP-Deficient Advanced Solid Tumors

Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows that a Phase I open-label, multicenter study evaluating the pharmacokinetics, safety, and tolerability of BMS-986504 in participants with advanced solid tumors with homozygous MTAP deletion in Japan and China has been initiated by Bristol-Myers Squibb Company/Bristol-Myers Squibb (China) Co., Ltd./Bristol Myers Squibb Co. The clinical trial registration number is CTR20253830, and the initial information disclosure date was September 22, 2025.

The drug formulation is in tablet form, and the dosage regimen should start with administration in the morning on Day 1 of the PK lead-in period until Day 15 of Cycle 1. On all other days, it is administered continuously once daily at 600 mg (in a 3-week cycle), continuing until disease progression or the occurrence of unacceptable toxicity. The primary objective of this trial is to evaluate the PK of BMS-986504 in Japanese and Chinese participants with advanced solid tumors harboring homozygous MTAP deletion. The secondary objective is to analyze the safety and tolerability of BMS-986504 in participants with advanced solid malignancies with homozygous MTAP deletion. Exploratory objectives include exploring potential pharmacodynamic biomarkers of PRMT5 inhibition in the blood (not applicable in China), among others.

BMS-986504 Tablets are a chemical drug indicated for advanced solid tumors with MTAP loss. Advanced solid tumors with MTAP loss refer to solid tumors where the MTAP gene is absent in the tumor tissue and the disease has progressed to an advanced stage. Symptoms vary depending on the tumor type, commonly including pain and fatigue, and diagnosis relies on genetic testing and imaging examinations.

The primary endpoint indicators of this trial include the measurement results of BMS-986504 PK parameters, including Cmax, Tmax, AUC, T-HALF, CLT/F, Vz/F, and other applicable parameters; secondary endpoint indicators include DLT assessment, treatment-related and all-cause AE, SAE, and AE leading to drug suspension, dose reduction, treatment termination, fatal AE, and the incidence of abnormal laboratory test values.

Currently, the trial status is ongoing (not yet recruiting), with a target enrollment of 16 participants in China and 32 participants internationally.

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Editor: Xiaolang Express