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Phase 1/2Recruiting

Study of ISM3412 in Participants With Locally Advanced/Metastatic Solid Tumors

A Phase 1/2, Open-Label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Preliminary Efficacy of ISM3412 in Participants With Locally Advanced/Metastatic Solid Tumors

Sponsor
InSilico Medicine Hong Kong Limited (Industry)
Enrolment
146 planned
Conditions
Locally Advanced/Metastatic Solid Tumors
Interventions
ISM3412
Ages
adults, older adults
Registry
NCT06414460

Full record on ClinicalTrials.gov

From the registry

The study has consists of two parts, a dose escalation part (Part 1) and a dose selection optimization part (Part 2). The primary objectives of this study are to evaluate the safety and tolerability of ISM3412 in participants with locally advanced/metastatic solid tumors, and to determine the RP2D of ISM3412.

Primary outcomes

  • Incidence of dose-limiting toxicity (DLT) events
  • Incidence and severity of adverse events (AEs)
  • Recommended phase 2 dose (RP2D)

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Started

  5. Registered