Trials / Recruiting
RecruitingNCT06414460
Study of ISM3412 in Participants With Locally Advanced/Metastatic Solid Tumors
A Phase 1, 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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- InSilico Medicine Hong Kong Limited · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ISM3412 | ISM3412 will be administered orally once daily. |
Timeline
- Start date
- 2025-04-25
- Primary completion
- 2028-03-31
- Completion
- 2029-03-31
- First posted
- 2024-05-16
- Last updated
- 2025-12-11
Locations
9 sites across 2 countries: United States, China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06414460. Inclusion in this directory is not an endorsement.