Phase 1 trial evaluates safety and efficacy of IAP antagonist APG-1387 in refractory pancreatic cancer, indicating potential for improved treatment options.
Advanced pancreatic cancer presents dismal survival with limited effective, well-tolerated options beyond chemotherapy. This phase 1 trial evaluates the safety, tolerability, and efficacy of bivalent IAP antagonist APG-1387 with nab-paclitaxel and gemcitabine (AG) in patients failing or intolerant to standard care. In 28-day cycles, patients receive intravenous infusions of APG-1387 (20, 30, or 45 mg) on days 1, 8, 15, and 22, and nab-paclitaxel (125 mg/m2) and gemcitabine (1,000 mg/m2) on days 1, 8, and 15, with dose-limiting toxicity (DLT) as the primary endpoint per NCI CTCAE v5.0. Of 28 screened, 21 are enrolled; one grade 4 DLT recovers within 3 days, and 9 (42.9%) experience grade ≥3 treatment-related adverse events, mostly AG-related bone marrow toxicities. Among 15 efficacy-evaluable patients, 3 achieve partial responses, including 1 (33%) without prior AG. APG-1387 with AG demonstrates tolerability and encouraging posterior-line antitumor effects in AG-naive patients (NCT04643405).
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Shi et al. (2025) studied this question.
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