A Study of BMS-986504 With Standard-of-Care Therapy for People With Solid Tumor Cancer (NCT07532902) | Clinical Trial Compass
RecruitingPhase 1
A Study of BMS-986504 With Standard-of-Care Therapy for People With Solid Tumor Cancer
United States60 participantsStarted 2026-04-07
Plain-language summary
The researchers are doing this study to test the safety of BMS-986504 in combination with standard disease-specific anticancer medication in people with metastatic/advanced unresectable MTAP-deleted solid tumor cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Documentation of Disease:
* Patients must have pathologic confirmation of one of three diseases:
* Diffuse pleural mesothelioma (DPM)
* Gastroesophageal carcinoma (GEC) including adenocarcinoma or squamous cell carcinoma of the esophagus, gastroesophageal junction, or stomach.
* PD-L1 CPS ≥1 (using clone 73-10, DAKO)
* HER2 overexpression negative (using clone 4B5, Ventana): HER2 IHC 0-1+, or HER2 2+ with ISH showing HER2:CEP17 ratio \<2 and average HER2 copy number \<6.0 signals/cell
* Urothelial carcinoma (UC)
* Archival tissue is acceptable
* Metastatic or advanced/unresectable disease:
* For Diffuse Pleural Mesothelioma (DPM) and Gastroesophageal Carcinoma (GEC )cohorts: no prior systemic treatment for metastatic disease
* Patients with metastatic disease after treatment for localized GEC may have received prior systemic therapy (chemotherapy and/or chemoradiation) if \>6 months have elapsed between the end of therapy and registration.
* One prior cycle of standard-of-care therapy alone without BMS-986504 or other MTAP inhibitors (ipi/nivo for DPM, FOLFOX + nivo for GEC) is acceptable with PI approval.
* For UC cohort: must have received at least 1 prior line of treatment without prior gemcitabine (prior tx with Gem+Platinum in the perioperative setting is permitted if at least 12 months have elapsed from trial enrollment)
* Patients with recurrent disease within 1 year of completion of prior perioperative systemic therapy are eligible with PI appro…
What they're measuring
1
determine a recommended phase II dose (RP2D) of BMS-986504 in combination with standard-of-care therapy