RecruitingRecruiting
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)
NCT07492680 · Bristol-Myers Squibb
In plain English
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Official title
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
About this study
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.
Eligibility criteria
Inclusion Criteria:
* Participant must have histologically confirmed diagnosis of advanced and/or metastatic solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue.
* Depending on the cohort enrolled, participants must have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment (there must be no available treatment with curative intent or participant is ineligible or declines treatment) or be treatment-naïve with no prior systemic anticancer therapy for their unresectable or metastatic disease.
* Participant must have presence of at least one measurable tumor lesion per RECIST v1.1 or mRECIST at baseline.
* Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) must be ≤ 1.5 × ULN; subjects with liver metastasis or liver cancer must be ≤ 2 × ULN.
* Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion Criteria:
* Participants must not have prior treatment with a PRMT5 or Methionine adenosyl transferase 2A (MAT2A) inhibitor.
* Participants must not have active brain metastases or carcinomatous meningitis. Participants are eligible if brain metastases are adequately treated, and participants are neurologically stable for at least 2 weeks prior to enrollment without the use of corticosteroids or are on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).
* Participants must not have history of gastrointestinal disease or other gastrointestinal conditions within 6 months prior to enrollment (including uncontrolled nausea, vomiting, malabsorption syndrome or non-gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess) likely to alter absorption of study treatment or result in inability to swallow oral medications.
* Participants must not have inadequate organ function, as determined by laboratory testing within the screening period.
* Participants must not have active viral HBV or HCV hepatitis.
* Other protocol defined inclusion/exclusion criteria applies.
Study design
Enrollment target: 260 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-07-27
Estimated completion: 2032-05-20
Last updated: 2026-09-16
Interventions
Drug: BMS-986504Drug: DaraxonrasibDrug: Nivolumab + Relatlimab FDCDrug: TemozolomideDrug: PumitamigDrug: PemetrexedDrug: CarboplatinDrug: Nab-paclitaxelDrug: GemcitabineDrug: Paclitaxel
Primary outcomes
- • Part 1: Number of participants who achieve Objective Response (OR) (Up to approximately 2 years)
- • Part 2: Number of participants with adverse events meeting protocol defined dose limiting toxicities (DLTs) criteria (Up to approximately 2 years)
- • Part 2: Number of participants with adverse events (AE) (Up to approximately 2 years)
Sponsor
Bristol-Myers Squibb · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (58)
Local Institution - 0096Not Yet Recruiting
San Francisco, California, United States
Local Institution - 0182Not Yet Recruiting
Aurora, Colorado, United States
Emory University - Winship Cancer InstituteRecruiting
Atlanta, Georgia, United States
Johns Hopkins HospitalRecruiting
Baltimore, Maryland, United States
Local Institution - 0124Not Yet Recruiting
Boston, Massachusetts, United States
Local Institution - 0119Not Yet Recruiting
Ann Arbor, Michigan, United States
Local Institution - 0129Not Yet Recruiting
Rochester, Minnesota, United States
Local Institution - 0174Not Yet Recruiting
Rochester, Minnesota, United States
Local Institution - 0181Not Yet Recruiting
Rochester, Minnesota, United States
Local Institution - 0142Not Yet Recruiting
Buffalo, New York, United States
Local Institution - 0170Not Yet Recruiting
New York, New York, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Local Institution - 0100Not Yet Recruiting
Durham, North Carolina, United States
Local Institution - 0085Not Yet Recruiting
Houston, Texas, United States
Local Institution - 0086Not Yet Recruiting
Seattle, Washington, United States
Local Institution - 0134Not Yet Recruiting
Madison, Wisconsin, United States
UZ BrusselRecruiting
Brussels, Bruxelles-Capitale, Région de, Belgium
Local Institution - 0148Not Yet Recruiting
Brussels, Bruxelles-Capitale, Région de, Belgium
Local Institution - 0114Not Yet Recruiting
Ghent, Oost-Vlaanderen, Belgium
Local Institution - 0051Not Yet Recruiting
Vancouver, British Columbia, Canada
Local Institution - 0021Not Yet Recruiting
Toronto, Ontario, Canada
Local Institution - 0007Not Yet Recruiting
Toronto, Ontario, Canada
Local Institution - 0155Not Yet Recruiting
Beijing, Beijing Municipality, China
Local Institution - 0185Not Yet Recruiting
Chongqing, Chongqing Municipality, China
Local Institution - 0184Not Yet Recruiting
Guangzhou, Guangdong, China
The First Affiliated Hospital of Henan Medical UniversityRecruiting
Xinxiang, Henan, China
Shanghai GoBroad Cancer Hospital China Pharmaceutical UniversityRecruiting
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer CenterRecruiting
Shanghai, Shanghai Municipality, China
Local Institution - 0078Not Yet Recruiting
Dijon, Côte-d'Or, France
Local Institution - 0075Not Yet Recruiting
Pierre-Bénite, Rhône, France
Local Institution - 0116Not Yet Recruiting
Villejuif, Val-de-Marne, France
Local Institution - 0074Not Yet Recruiting
Paris, France
Local Institution - 0081Not Yet Recruiting
Mainz, Rhineland-Palatinate, Germany
Universitaetsklinikum HamburgRecruiting
Hamburg, Germany
Local Institution - 0039Not Yet Recruiting
Heidelberg, Germany
Local Institution - 0061Not Yet Recruiting
Leipzig, Germany
Local Institution - 0049Not Yet Recruiting
München, Germany
Local Institution - 0047Not Yet Recruiting
Würzburg, Germany
Local Institution - 0150Not Yet Recruiting
Hksar, Hong Kong
Local Institution - 0063Not Yet Recruiting
Shatin, Hong Kong
Cork University HospitalRecruiting
Cork, Ireland
Mater Misericordiae University Hospital (MMUH)Recruiting
Dublin, Ireland
Local Institution - 0146Not Yet Recruiting
Dublin, Ireland
Local Institution - 0073Not Yet Recruiting
Siena, Tuscany, Italy
Local Institution - 0123Not Yet Recruiting
Bergamo, Italy
Local Institution - 0034Not Yet Recruiting
Milan, Italy
Local Institution - 0050Not Yet Recruiting
Naples, Italy
Local Institution - 0082Not Yet Recruiting
Perugia, Italy
National Cancer Center HospitalRecruiting
Chuo-ku, Tokyo, Japan
Haukeland UniversitetssjukehusRecruiting
Bergen, Hordaland, Norway
Oslo Universitetssykehus HF, UllevålRecruiting
Oslo, Norway
Seoul National University HospitalRecruiting
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Severance Hospital, Yonsei University Health SystemRecruiting
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Asan Medical CenterRecruiting
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0068Not Yet Recruiting
Barcelona, Barcelona [Barcelona], Spain
Local Institution - 0071Not Yet Recruiting
Hospitalet, Barcelona [Barcelona], Spain
Local Institution - 0033Not Yet Recruiting
Madrid, Spain
Hospital Universitario Virgen Del RocioRecruiting
Seville, Spain