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NCT07492680

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)

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Aún no reclutando Fase 2

Descripción

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.

Criterios de Elegibilidad

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.

Información del Ensayo

NCT07492680
Aún no reclutando
Fase 2
260 participantes
Jul 2026
May 2032

Ubicaciones58

Belgium (1)
Local Institution - 0114
Ghent, Oost-Vlaanderen, 9000
Canada (3)
Local Institution - 0051
Vancouver, British Columbia, V2S 0C2
Local Institution - 0007
Toronto, Ontario, M5G 2M9
Local Institution - 0021
Toronto, Ontario, M4N 3M5
China (5)
Local Institution - 0155
Beijing, Beijing Municipality, 100071
Local Institution - 0185
Chongqing, Chongqing Municipality, 400030
Local Institution - 0184
Guangzhou, Guangdong, 510060
Local Institution - 0153
Shanghai, Shanghai Municipality, 200032
Local Institution - 0156
Shanghai, Shanghai Municipality, 200131
France (4)
Local Institution - 0074
Paris, 75010
Local Institution - 0078
Dijon, Côte-d'Or, 21079
Local Institution - 0075
Pierre-Bénite, Rhône, 69310
Local Institution - 0116
Villejuif, Val-de-Marne, 94800
Germany (6)
Local Institution - 0040
Hamburg, 20246
Local Institution - 0039
Heidelberg, 69120
Local Institution - 0061
Leipzig, 04103
Local Institution - 0049
München, 81675
Local Institution - 0047
Würzburg, 97080
Local Institution - 0081
Mainz, Rhineland-Palatinate, 55131
Hong Kong (2)
Local Institution - 0150
Hksar, 999077
Local Institution - 0063
Shatin, NT
Ireland (3)
Local Institution - 0080
Cork, T12 E8YV
Local Institution - 0023
Dublin, 7
Local Institution - 0146
Dublin, D08 E9P6
Italy (5)
Local Institution - 0123
Bergamo, 24127
Local Institution - 0034
Milan, 20133
Local Institution - 0050
Naples, 80131
Local Institution - 0082
Perugia, 06156
Local Institution - 0073
Siena, Tuscany, 53100
Japan (1)
Local Institution - 0020
Chuo-ku, Tokyo, 104-0045
Norway (2)
Local Institution - 0022
Oslo, 0450
Local Institution - 0171
Bergen, Hordaland, 5021
South Korea (3)
Local Institution - 0004
Seoul, Seoul-teukbyeolsi [Seoul], 03080
Local Institution - 0052
Seoul, Seoul-teukbyeolsi [Seoul], 05505
Local Institution - 0058
Seoul, Seoul-teukbyeolsi [Seoul], 03722
Spain (5)
Local Institution - 0033
Madrid, 28028
Local Institution - 0069
Seville, 41013
Local Institution - 0068
Barcelona, Barcelona [Barcelona], 08035
Local Institution - 0071
Hospitalet, Barcelona [Barcelona], 08907
Local Institution - 0059
Madrid, Madrid, Comunidad de, 28034
United States (18)
Local Institution - 0096
San Francisco, California, 94158
Local Institution - 0182
Aurora, Colorado, 80045
Local Institution - 0122
Tampa, Florida, 33612
Local Institution - 0178
Atlanta, Georgia, 30322
Local Institution - 0106
Chicago, Illinois, 60637
Local Institution - 0143
Baltimore, Maryland, 21287
Local Institution - 0124
Boston, Massachusetts, 02114
Local Institution - 0119
Ann Arbor, Michigan, 48109-0922
Local Institution - 0129
Rochester, Minnesota, 55905
Local Institution - 0174
Rochester, Minnesota, 55905
Local Institution - 0181
Rochester, Minnesota, 55905
Local Institution - 0142
Buffalo, New York, 14263
Local Institution - 0139
New York, New York, 10065
Local Institution - 0170
New York, New York, 10016
Local Institution - 0100
Durham, North Carolina, 27705
Local Institution - 0085
Houston, Texas, 77030
Local Institution - 0086
Seattle, Washington, 98109
Local Institution - 0134
Madison, Wisconsin, 53792