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

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.

Conditions

Solid Tumor, Adult

Study Overview

Study Details

Study overview

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.

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

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

Condition
Solid Tumor, Adult
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

New Haven

Yale Cancer Center, New Haven, Connecticut, United States, 06519

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Albuquerque

University of New Mexico Comprehensive Cancer Center, Albuquerque, New Mexico, United States, 87106

New York

Columbia University Herbert Irving Comprehensive Cancer Center, New York, New York, United States, 10032

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19106

Philadelphia

Thomas Jefferson University, Sidney Kimmel Cancer Center, Philadelphia, Pennsylvania, United States, 19107

Houston

MD Anderson Cancer Center, Houston, Texas, United States, 77030

San Antonio

The START Center for Cancer Care, San Antonio, Texas, United States, 78229

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Linnaeus Therapeutics, Inc.,

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

    Study Record Dates

    2024-12-15