RECRUITING

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

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Conditions

Solid Tumor, AdultMelanoma, Uveal Melanoma, NSCLC, Colorectal, Pancreatic, and Gastric Cancers

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2019-10-21
Study Completion:2024-12-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04130516

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Tina Garyantes, PhD
CONTACT
(908) 420-1159
tgaryantes@linnaeustx.com
Mackenzie Tseng-Lee, MBA
CONTACT
(513) 579-9911
m.tseng-lee@medpace.com

Principal Investigator

Tina Garyantes, PhD
STUDY_DIRECTOR
Linnaeus Therapeutics, Inc.

Study Locations (Sites)

Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Yale Cancer Center
New Haven, Connecticut, 06519
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87106
United States
Columbia University Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19106
United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
The START Center for Cancer Care
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Linnaeus Therapeutics, Inc.

  • Tina Garyantes, PhD, STUDY_DIRECTOR, Linnaeus Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-10-21
Study Completion Date2024-12-15

Study Record Updates

Study Start Date2019-10-21
Study Completion Date2024-12-15

Terms related to this study

Keywords Provided by Researchers

  • Melanoma, Uveal Melanoma, NSCLC, Colorectal, Pancreatic, and Gastric Cancers

Additional Relevant MeSH Terms

  • Solid Tumor, Adult