clinical trial · NCT06724042
Study of ISM5939 in Patients With Advanced and/or Metastatic Solid Tumors
InSilico Medicine Hong Kong Limited·phase1·not yet recruiting·n = 159
Advanced Solid TumorMetastatic Solid TumorAdvanced and/or Metastatic Solid TumorsISM5939CisplatinDocetaxelPembrolizumab
brief summary
This is a first-in-human Phase 1a/b, open-label, multicenter, dose escalation, optimization and expansion study of ISM5939 to evaluate the safety, tolerability, PK, PD, and preliminary antitumor activity of ISM5939 in patients with advanced or metastatic solid tumors. The study will be conducted in 3 parts sequentially: Part 1 dose escalation ISM5939 monotherapy, Part 2 dose optimization to determine RP2D of ISM5939 monotherapy, and Part 3 dose expansion in 3 cohorts after initial safety run-in of ISM5939 combination therapy.
started
Jun 30, 2026
primary completion
Jun 30, 2029
completion
Jun 30, 2030
last updated
Dec 10, 2025
official title
First-in-human Phase 1a/b, Open-Label, Multicenter, Dose Escalation, Optimization and Expansion Study of ISM5939 in Patients With Advanced and/or Metastatic Solid Tumors
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol