TRIDENT-1-PANC

NCT03093116 📎

Regimen

Experimental
Repotrectinib 160 mg PO QD ×14 days then 160 mg BID continuous
Control
single-arm / no comparator (historical benchmark = disease progression on 1st-gen TRK inhibitors)

Population

Advanced solid tumors with NTRK1/2/3 fusion; NTRK-fusion tumor-agnostic cohort n=88 (TKI-naive n=19 + TKI-pretreated n=69). PDAC pts included within the broader NTRK cohort. Pancreatic case reports published separately.

Key finding

FDA accelerated approval June 2024 for NTRK fusion-positive advanced solid tumors (tumor-agnostic) — the next-generation TRK inhibitor with activity after progression on 1st-gen (larotrectinib/entrectinib), including against solvent-front mutations (G595R/G667C). For PDAC pts with NTRK fusions who progress on 1st-gen TRK, repotrectinib provides a next-line precision option. CNS-active.

Guideline citations

  • NCCN PANCREATIC (p.65)