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

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.

Trial Details

NCT ID
NCT04130516
Phase
PHASE1 / PHASE2
Sponsor
Linnaeus Therapeutics, Inc.
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • LNS8801 -Small molecule, orally bioavailable, selective agonist of GPER
  • Pembrolizumab - anti-PD-1 antibody
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • Albuquerque, New Mexico, United States|35.08449,-106.65114
  • New York, New York, United States|40.71427,-74.00597

Key Eligibility Criteria

  • Has histopathologically confirmed locally advanced or metastatic solid tumor cancer.
  • Is able to understand and voluntarily sign a written informed consent form and is willing and able to comply with protocol requirements.
  • Is considered likely to meet the detailed inclusion and exclusion criteria for treatment when required.
  • Inclusion Criteria for treatment portion of study:

For full eligibility, visit ClinicalTrials.gov.

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