Study Assessing MTD, Safety, Tolerability, PK and Anti-tumor Effects of LNS8801alone and With Pembrolizumab
Running, not enrolling · Phase 1/Phase 2
Conditions studied: Solid Tumor, Adult
In brief
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.
Key facts
- Study ID
- NCT04130516
- Run by
- Linnaeus Therapeutics, Inc.
- People needed
- 200
- Starts
- 2019-10-21
- Expected to finish
- 2026-08-15
- Last updated by the study team
- 2026-07-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Cedars-Sinai Medical Center — Los Angeles, California, United States
- Yale Cancer Center — New Haven, Connecticut, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- University of New Mexico Comprehensive Cancer Center — Albuquerque, New Mexico, United States
- Columbia University Herbert Irving Comprehensive Cancer Center — New York, New York, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- Thomas Jefferson University, Sidney Kimmel Cancer Center — Philadelphia, Pennsylvania, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- The START Center for Cancer Care — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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