Trials / Not Yet Recruiting
Not Yet RecruitingNCT07492680
A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
A Phase 2 Open-Label, Multi-Center Study of BMS-986504 as Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 260 (estimated)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label, multicenter Phase 2 study evaluating BMS-986504 in participants with advanced and/or metastatic solid tumors that have MTAP deletion. The study includes a monotherapy component and a combination component in which BMS-986504 is given with other anti-cancer agents. The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of BMS-986504 alone and in combination regimens.
Detailed description
Part 1 will include parallel enrolment of tumor-specific dose-expansion cohorts evaluating BMS-986504 as monotherapy. Part 2 will include dose-escalation cohorts in which BMS-986504 is given in combination with other anticancer agents. Additional cohorts may be added based on emerging data.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BMS-986504 | Specified dose on specified days |
| DRUG | Daraxonrasib | Specified dose on specified days |
| DRUG | Nivolumab + Relatlimab FDC | Specified dose on specified days |
| DRUG | Temozolomide | Specified dose on specified days |
| DRUG | Pumitamig | Specified dose on specified days |
| DRUG | Pemetrexed | Specified dose on specified days |
| DRUG | Carboplatin | Specified dose on specified days |
| DRUG | Nab-paclitaxel | Specified dose on specified days |
| DRUG | Gemcitabine | Specified dose on specified days |
| DRUG | Paclitaxel | Specified dose on specified days |
Timeline
- Start date
- 2026-07-17
- Primary completion
- 2032-05-20
- Completion
- 2032-05-20
- First posted
- 2026-03-25
- Last updated
- 2026-03-25
Locations
55 sites across 13 countries: United States, Belgium, Canada, China, France, Germany, Hong Kong, Ireland, Italy, Japan, Norway, South Korea, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07492680. Inclusion in this directory is not an endorsement.