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NCT04130516 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Solid Tumor, Adult, sponsored by Linnaeus Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
200
Enrollment target
10
Study locations

NCT04130516 is a Phase 1 study of Solid Tumor, Adult that is actively recruiting participants, run by Linnaeus Therapeutics. The registered enrollment target is 200 participants, roughly in line with the 188-participant average among 72 other Solid Tumor, Adult trials with a reported enrollment target. The trial reports 10 study locations across 7 states.

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The verdict

NCT04130516, a Phase 1 study of Solid Tumor, Adult, is actively recruiting participants, sponsored by Linnaeus Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
200 participants
Enrollment target
10
Study locations

Study 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.

Conditions Studied

Solid Tumor, Adult

Interventions

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

Study Locations (10)

New York

  • Columbia University Herbert Irving Comprehensive Cancer Center - New York
  • Memorial Sloan Kettering Cancer Center - New York

Pennsylvania

  • University of Pennsylvania - Philadelphia
  • Thomas Jefferson University, Sidney Kimmel Cancer Center - Philadelphia

Texas

  • MD Anderson Cancer Center - Houston
  • The START Center for Cancer Care - San Antonio

California

  • Cedars-Sinai Medical Center - Los Angeles

Connecticut

  • Yale Cancer Center - New Haven

Massachusetts

  • Massachusetts General Hospital - Boston

New Mexico

  • University of New Mexico Comprehensive Cancer Center - Albuquerque

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2019-10-21
Est. Completion 2027-12-15
Phase Phase 1

Sponsor

Linnaeus Therapeutics

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04130516

The ClinicalTrials.gov registry entry for NCT04130516 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 188-participant average among 72 other Solid Tumor, Adult trials with a reported enrollment target. The listed sponsor is Linnaeus Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Solid Tumor, Adult appearing as the primary indexed condition, and to 2 interventions - of which LNS8801 -Small molecule, orally bioavailable, selective agonist of GPER is the first listed.

NCT04130516 reports 10 study locations spanning 7 distinct geographic areas - top geographies include New York, Pennsylvania, Texas.

Frequently Asked Questions

What is clinical trial NCT04130516 about?

NCT04130516 is a clinical study titled "Study Assessing MTD, Safety, Tolerability, PK and Anti-tumor Effects of LNS8801alone and With Pembrolizumab". 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 escalat...

What is the current status of trial NCT04130516?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 200 participants. The study started on 2019-10-21. Estimated completion is 2027-12-15.

What conditions does trial NCT04130516 study?

This clinical trial studies the following conditions: Solid Tumor, Adult.

What interventions are being tested in trial NCT04130516?

The interventions under investigation include: LNS8801 -Small molecule, orally bioavailable, selective agonist of GPER (DRUG), Pembrolizumab - anti-PD-1 antibody (BIOLOGICAL).

Who is sponsoring clinical trial NCT04130516?

This trial is sponsored by Linnaeus Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04130516 being conducted?

This trial has 10 study locations across California, Connecticut, Massachusetts, New Mexico, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.