NCT06724042

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 159 (estimated)
• Sponsor: InSilico Medicine Hong Kong Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumor
• Metastatic Solid Tumor
• Advanced and/or Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	ISM5939	ISM5939 tablets will be administered orally once daily (QD).
DRUG	Cisplatin	Cisplatin will be administered intravenously in combination with ISM5939 on day 1 during each cycle.
DRUG	Docetaxel	Docetaxel will be administered intravenously in combination with ISM5939 on day 1 during each cycle.
DRUG	Pembrolizumab	Pembrolizumab will be administered intravenously in combination with ISM5939 on day 1 during each cycle.

Timeline

• Start date: 2026-06-30
• Primary completion: 2029-06-30
• Completion: 2030-06-30
• First posted: 2024-12-09
• Last updated: 2025-12-10

Regulatory

• FDA-regulated drug study