Onivyde (nanoliposomal irinotecan)

nal-IRI demonstrated IC activity in HER2[-] BC with BMs. While overall efficacy was limited and long-term outcomes remain poor, these results highlight the unmet need in this challenging population and support the importance of developing more treatment strategies.

P1/2, N=90, Recruiting, St. Jude Children's Research Hospital | Active, not recruiting --> Recruiting | N=46 --> 90

This optimized dosing schedule successfully established the MTD for RUB with nal-IRI and 5-FU, overcoming prior challenges with PARP inhibitor and irinotecan combinations. The promising ORR and DCR support further evaluation of this regimen in advanced GI malignancies.

P2, N=52, Recruiting, Medical University of South Carolina | Not yet recruiting --> Recruiting | Trial completion date: Mar 2027 --> Nov 2029 | Trial primary completion date: Mar 2026 --> May 2028

BTCs have been traditionally managed with gemcitabine and cisplatin (GC), but this standard of care has shown limited efficacy due to early recurrence, high resistance rates, and molecular heterogeneity...Additionally, novel regimens including nanoliposomal irinotecan and dual ICI combinations represent viable second-line options...Personalized treatment guided by molecular characteristics is now central to improving outcomes. Future efforts must prioritize the identification of biomarkers, clarification of resistance mechanisms, and optimization of multimodal treatment strategies to maximize patient benefit.

P4, N=30, Not yet recruiting, Subei People's Hospital; Subei People's Hospital

P1, N=30, Not yet recruiting, The Affiliated Hospital of Qingdao University; The Affiliated Hospital of Qingdao University

P4, N=144, Not yet recruiting, Zhongshan Hospital, Fudan University; Zhongshan Hospital, Fudan University

TTF1 is not predictive of TTF2 or OS. Therefore, 2nd-line treatment should not be withheld irrespective of duration of TTF1. CA 19-9 dynamics can be used to predict further benefit to some extent.

P2, N=52, Not yet recruiting, Medical University of South Carolina | Initiation date: Sep 2025 --> Jan 2026

This first real-world analysis of NALIRIFOX confirms its clinical effectiveness and manageable toxicity in an unselected patient population. The favorable outcomes in HRRm subgroups and the prognostic impact of KRAS variants underscore the need for molecular stratification in guiding first-line therapy for mPDAC.

P2, N=93, Completed, AIO-Studien-gGmbH | Active, not recruiting --> Completed