Last updated on April 2020

Phase 1 Study to Determine the MTD Safety Tolerability PK and Preliminary Anti-tumor Effects of LNS8801

Brief description of study

LNS-101 is a multi-center study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of LNS8801 in patients with advanced cancer. This Phase 1, first-in-human, open-label, multi-center study is designed to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D). LNS8801 will be administered until disease progression or unacceptable toxicity.

Detailed Study Description

This Phase 1, first-in-human, open-label, multi-center study follows a 3+3 ascending dose escalation design to determine the MTD/RP2D and to characterize the safety, tolerability, PK, and anti-tumor effects of LNS8801. LNS8801 will be administered for three consecutive days per week (Day 1 to Day 3 of each week) for each 21 day cycle until disease progression or unacceptable toxicity occurs.

Cohorts will enroll at least three patients in accordance with a traditional 3+3 design, and the study will determine the MTD/RP2D. With permission from the Safety Review Committee (SRC), two cohorts may be expanded to include 8 to 10 patients to further explore PK and pharmacodynamics.

Safety assessments will be performed on all patients at screening, throughout their participation in the study, and for 30 days following the last dose of study drug. Throughout the study, imaging of tumors for evidence of tumor response and/or progression will be performed; biopsies will be performed on accessible lesions.

Up to 50 patients will be accrued for this study. LNS8801 capsules will be administered orally. There are up to five study sites in the United States.

Clinical Study Identifier: NCT04130516

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