drugset / Trial / NCT04130516
Study Assessing MTD, Safety, Tolerability, PK and Anti-tumor Effects of LNS8801alone and With Pembrolizumab
Phase 1/2
Active not recruiting
200 enrolled
Linnaeus Therapeutics, Inc.
Merck Sharp & Dohme LLC · collab
NaSingle-groupOpen-labelTreatment
Summary
This Phase 1/2, first-in-human, open-label, multicenter study follows a 3+3 ascending dose escalation design to determine the MTD/RP2D and to characterize the safety, tolerability, PK, and antitumor effects of LNS8801 alone and in combination with pembrolizumab. The study will include a dose escalation phase, a dose expansion phase, and phase 2A cohorts. Up to 200 patients will be accrued for this study. Up to 15 study sites in the United States will participate in the study.
Timeline
- Start
- 2019-10-21
- Primary completion
- 2026-06-30
- Completion
- 2026-08-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LNS8801 | Small molecule | 125 mg | Oral |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |