A Multicenter Phase 1-2A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of LNS8801 in Patients With Advanced Cancer With and Without Pembrolizumab
Linnaeus Therapeutics, Inc.
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.
Description
In this Phase 1/2, first-in-human, open-label, multi-center study. Dose escalation cohorts enrolled at least 3 patients in accordance with a traditional dose escalation 3+3 design, and the study will determine the MTD/RP2D of LNS8801. LNS8801 will be administered orally 3 days/week or once or twice a day during 21 day cycles until disease progression or unacceptable toxicity occurs. Safety assessments will be performed on all patients at screening, throughout their participation in the study, and for 30 days (90 days in combination cohorts) following the last dose of study drug. Throughout th…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Prescreening Inclusion Criteria for genotyping: 1. Has histopathologically confirmed locally advanced or metastatic solid tumor cancer. 2. Is able to understand and voluntarily sign a written informed consent form and is willing and able to comply with protocol requirements. 3. Is considered likely to meet the detailed inclusion and exclusion criteria for treatment when required. Inclusion Criteria for treatment portion of study: 1. Has histopathologically confirmed locally advanced or metastatic solid tumor cancer (or lymphoma in Phase 1). The solid tumor cancer is further defined in some…
Interventions
- DrugLNS8801 -Small molecule, orally bioavailable, selective agonist of GPER
LNS8801 -Small molecule, orally bioavailable, selective agonist of GPER
- BiologicalPembrolizumab - anti-PD-1 antibody
pembrolizumab- anti-PD-1 antibody
Locations (10)
- Cedars-Sinai Medical CenterLos Angeles, California
- Yale Cancer CenterNew Haven, Connecticut
- Massachusetts General HospitalBoston, Massachusetts
- University of New Mexico Comprehensive Cancer CenterAlbuquerque, New Mexico
- Columbia University Herbert Irving Comprehensive Cancer CenterNew York, New York
- Memorial Sloan Kettering Cancer CenterNew York, New York