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Protocol # 21-258

Status

Recruiting

Description

This Phase 1, 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 ten study sites in the United States will participate in the study.

Condition

  • Solid Tumor, Adult

Interventions

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

Phase

Phase 1/Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • The primary outcome of this study during dose escalation is to the determination of the MTD or RP2D of LNS8801 dosed alone and in combination with pembrolizumab
  • The primary outcome measure after dose escalation is to assess the anticancer activity of LNS8801 alone or in combination with pembrolizumab as measured by progression free survival in uveal melanoma and overall response rate for all other cohorts

Secondary Outcome:

  • To assess the Cmax of ascending doses of LNS8801
  • To assess the AUC of ascending doses of LNS8801
  • To assess accumulation of LNS8801 during ascending doses
  • To assess the number of participants with treatment related adverse events assessed by CTCAE v4.0 dosed with LNS8801 alone.
  • To assess the number of participants with treatment related adverse events assessed by CTCAE v4.0 dosed with LNS8801 and pembrolizumab.
  • Assess the clinical benefit rate (CBR) based on RECIST V1.1 criteria
  • Assess overall response rate (ORR) based on RECIST V1.1 criteria
  • Assess progression free survival (PFS) based on RECIST V1.1 criteria

Enrollment

200

Study Start Date

October 21, 2019

Eligibility

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

Sponsors

Linnaeus Therapeutics, Inc.

Source

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

Clinicaltrials.gov Identifier

NCT04130516

     

Source: Clinicaltrials.gov. 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.