drugset / Trial / NCT04130516

Study Assessing MTD, Safety, Tolerability, PK and Anti-tumor Effects of LNS8801alone and With Pembrolizumab

NCT04130516

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

EvaluationDrugModalityDoseRoute
Subject LNS8801 Small molecule 125 mg Oral
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous

Indications