Safety and drug-level testing of BMS-986504 for advanced solid tumors with MTAP deletion
A Phase 1 Open-Label, Multi-Center Study to Evaluate Pharmacokinetics, Safety and Tolerability of BMS-986504 in Japanese and Chinese Participants With Advanced Solid Tumors With Homozygous MTAP Deletion
This trial tests whether BMS-986504 is safe, tolerable, and reaches acceptable drug levels in adults with advanced solid tumors that have an MTAP gene deletion.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 12 sites (Beijing, Beijing Municipality and 11 other locations) |
| Trial ID | NCT07077434 on ClinicalTrials.gov |
What this trial studies
This phase 1, open-label trial gives single-agent BMS-986504 to adults with unresectable or metastatic solid tumors that have a homozygous MTAP deletion and measures safety, tolerability, and pharmacokinetics. Participants must have ECOG performance status 0–1 and at least one measurable lesion per RECIST 1.1 after progression on prior therapies. Key exclusions include prior PRMT5 or MAT2A inhibitor treatment, active brain metastases or carcinomatous meningitis, and gastrointestinal conditions likely to affect drug absorption. The trial is conducted at major cancer centers in Beijing, Fuzhou, and Guangzhou using dose-escalation methods typical of first-in-human/early-phase studies to identify safe dose ranges and drug-level profiles.
Who should consider this trial
Good fit: Adults with unresectable or metastatic solid tumors that have a confirmed homozygous MTAP deletion, ECOG 0–1, measurable disease per RECIST 1.1, and prior progression on standard therapies are the intended participants.
Not a fit: Patients without an MTAP homozygous deletion, those previously treated with PRMT5 or MAT2A inhibitors, or those with active brain metastases or GI conditions affecting absorption are unlikely to benefit from this trial.
Why it matters
Potential benefit: If safe and pharmacologically active, BMS-986504 could become a targeted option for patients with MTAP-deleted advanced solid tumors who have exhausted standard therapies.
How similar studies have performed: Targeting MTAP-deleted tumors through PRMT5/MAT2A pathways is an emerging approach with supportive preclinical data and some early-phase clinical signals, but large-scale clinical benefit has not yet been proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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/Exclusion criteria apply.
Where this trial is running
Beijing, Beijing Municipality and 11 other locations
- Beijing Cancer hospital — Beijing, Beijing Municipality, China (Recruiting)
- Fujian Cancer Hospital — Fuzhou, Fujian, China (Recruiting)
- Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)
- Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (Recruiting)
- Local Institution - 0006 — Harbin, Heilongjiang, China (Not_yet_recruiting)
- The First Affiliated Hospital of Xinxiang Medical University — Xinxiang, Henan, China (Recruiting)
- Shandong Cancer Hospital — Jinan, Shandong, China (Recruiting)
- Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
- Kanagawa cancer center — Yokohama, Kanagawa, Japan (Recruiting)
- Shizuoka Cancer Center — Sunto-gun, Shizuoka, Japan (Recruiting)
- National Cancer Center Hospital — Chuo-ku, Tokyo, Japan (Recruiting)
- The Cancer Institute Hospital of JFCR — Koto-ku, Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: BMS Study Connect Contact Center, www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.