RecruitingPhase 1Phase 2NCT04130516

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

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


Sponsor

Linnaeus Therapeutics, Inc.

Enrollment

200 participants

Start Date

Oct 21, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called LNS8801, alone or combined with an immunotherapy drug called pembrolizumab, in people with advanced or metastatic solid tumors or lymphoma that have not responded to other treatments. **You may be eligible if...** - You are 18 or older - You have a confirmed advanced or metastatic solid tumor or lymphoma that has progressed despite other treatments - Depending on the study group, you may need to have specific cancer types (e.g., melanoma, pancreatic, lung, colorectal, uveal melanoma, or breast cancer) or have previously received immunotherapy (PD-1/PD-L1 drugs) - You have adequate organ function (blood counts, kidney, liver) - You are willing and able to take oral capsules/tablets **You may NOT be eligible if...** - You have thyroid or gallbladder cancer (for early-phase groups only) - Your cancer is known to be estrogen receptor positive - You are currently on estrogen hormone replacement therapy or have estrogen-sensitive cancer - You have active autoimmune disease requiring treatment - You are HIV positive, have active hepatitis B or C - You are pregnant, breastfeeding, or have been pregnant within the last 2 years - You have severe heart problems or a history of serious immune-related side effects from prior immunotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLNS8801 -Small molecule, orally bioavailable, selective agonist of GPER

LNS8801 -Small molecule, orally bioavailable, selective agonist of GPER

BIOLOGICALPembrolizumab - anti-PD-1 antibody

pembrolizumab- anti-PD-1 antibody


Locations(10)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Yale Cancer Center

New Haven, Connecticut, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, United States

Columbia University Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Thomas Jefferson University, Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center

Houston, Texas, United States

The START Center for Cancer Care

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT04130516


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