本研究目的为评估 Navlimetostat (BMS-986504)（一种选择性、MTA 协同的 PRMT5 抑制剂）联合 Nab-paclitaxel/Gemcitabine (nab-p/gem) 与安慰剂联合 nab-p/gem 比较，用于带有同型合子甲基硫代腺苷磷酸化酶 (MTAP) 缺失的未曾接受治疗转移性胰腺导管腺癌 (PDAC) 参与者之安全性与疗效。
适应症：Pancreatic Ductal Adenocarcinoma
入组条件
纳入标准
- Histologically or cytologically confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma (PDAC).
- Evidence of homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss detected in tumor tissue.
- Metastatic disease with at least 1 measurable lesion as per Response Evaluation Criteria in Solid Tumors version v1.1 (RECIST v1.1).
- Participants must not have received any systemic anticancer treatments in the metastatic setting.
- If clinically indicated and as per investigator discretion, participants may receive up to 1 cycle of Nab-paclitaxel/Gemcitabine (nab-p/gem) in the metastatic setting and must have not progressed or required discontinuation due to intolerable toxicity.
- Initial cycle of nab-p/gem administered in the metastatic setting must have been completed prior to randomization.
排除标准
- Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to screening.
入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。