Clinical Trial

Study of ISM5939 in Patients With Advanced and/or Metastatic Solid Tumors

Not Yet Recruiting Phase 1
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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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2029-06-30 -> 2029-12-30 2026-07-24
minor Completion pushed: 2030-06-30 -> 2030-12-30 2026-07-24
Trial Details
NCT Number NCT06724042
Lead Sponsor InSilico Medicine Hong Kong Limited
Conditions Advanced Solid Tumor, Metastatic Solid Tumor, Advanced and/or Metastatic Solid Tumors
Enrollment 159 participants
Start Date 2026-12-30
Primary Completion 2029-12-30 (estimated)
Study Completion 2030-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-23