A Study to Assess Safety, Tolerability and Drug Levels of BMS-986504 in Participants With Advanced Solid Tumors

NCT07077434 | Recruiting Phase 1

• 1 other identifier: CA240-0010
• Study Type: interventional
• Target: 32
• Locations: 2 countries
• Sites: 12

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.

Conditions

Advanced Solid Tumors

Keywords

MTAP; PRMT5; MRTX1719; CDKN2A

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (10)

• Number of Participants With Dose-limiting Toxicities (DLTs)

  Up to approximately Day 25

• 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

Study Arms (1)

BMS-986504 Arm

EXPERIMENTAL

Drug: BMS-986504

Interventions

BMS-986504 DRUG

Specified dose on specified days

Also known as: MRTX1719

BMS-986504 Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (12)

Beijing Cancer hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510120, China

RECRUITING

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518036, China

RECRUITING

Local Institution - 0006

Harbin, Heilongjiang, 150081, China

NOT YET RECRUITING

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, 453100, China

RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Kanagawa cancer center

Yokohama, Kanagawa, 2418515, Japan

RECRUITING

Shizuoka Cancer Center

Sunto-gun, Shizuoka, 411-8777, Japan

RECRUITING

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

RECRUITING

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, 135-8550, Japan

RECRUITING

Related Links

• BMS Clinical Trial Information

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Study Connect Contact Center, www.BMSStudyConnect.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain the NCT# and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 22, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): January 19, 2027
• Study Completion (Estimated): January 19, 2027
• Last Updated: January 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

CN (8); JP (4)