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

ClinicalTrials.gov ID: NCT04130516

Public ClinicalTrials.gov record NCT04130516. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 29, 2026, 4:05 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT04130516
Recruitment status: Active, not recruiting
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Linnaeus Therapeutics, Inc.; Industry
Enrollment: 200 participants

Conditions and interventions

Conditions

Solid Tumor, Adult

Interventions

Drug · Biological

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 21, 2019 (Actual)
Primary completion: Jun 30, 2026 (Actual)
Completion: Aug 15, 2026 (Estimated)
Last update posted: Jul 13, 2026

2019 – 2026

United States locations

U.S. sites: 10
U.S. states: 7
U.S. cities: 8

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

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04130516, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 13, 2026 · Synced Oct 29, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04130516 live on ClinicalTrials.gov.

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