本研究目的為評估 Navlimetostat (BMS-986504)（一種選擇性、MTA 協同的 PRMT5 抑制劑）聯合 Nab-paclitaxel/Gemcitabine (nab-p/gem) 與安慰劑聯合 nab-p/gem 比較，用於帶有同型合子甲基硫代腺苷磷酸化酶 (MTAP) 缺失的未曾接受治療轉移性胰臟導管腺癌 (PDAC) 參與者之安全性與療效。
適應症：Pancreatic Ductal Adenocarcinoma
收案條件
納入條件
- 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.
排除條件
- Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to screening.
收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。