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Protocol # 21-258




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.


  • Solid Tumor, Adult


  • LNS8801 -Small molecule, orally bioavailable, selective agonist of GPER
  • Pembrolizumab - anti-PD-1 antibody


Phase 1/Phase 2

Study Type


Further Study Details

Primary Outcome:

  • Determination of the MTD or RP2D of LNS8801 dosed alone and in combination with pembrolizumab
  • Determination of appropriate patient populations for future pivotal studies based on overall response rate (ORR) and clinical benefit rate (CBR) as assessed by RECISTv1.1

Secondary Outcome:

  • LNS8801 PK plasma exposure and calculated parameters
  • Clinical benefit rate (CBR) of LNS8801 alone or in combination
  • Overall response rate (ORR) for LNS8801 alone and when dosed in combination with pembrolizumab
  • Progression free survival (PFS) for LNS8801 alone and when dosed in combination with pembrolizumab



Study Start Date

October 21, 2019


  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No


Linnaeus Therapeutics, Inc.


Linnaeus Therapeutics, Inc.

Official title

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 Identifier



Source: Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.