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

Sponsored by Linnaeus Therapeutics, Inc.

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Current Status

Recruiting

Auto-verified from ClinicalTrials.gov

Verified Dec 18, 2025

Phase

Clinical Trial

Sponsor

Linnaeus Therapeutics, Inc.

Enrollment Target

200

Start Date

Oct 2019

๐Ÿ“Š
1 of 200 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

Inclusion Criteria

for genotyping: 1. Has histopathologically confirmed locally advanced or metastatic solid tumor cancer. 2. Is able to understand and voluntarily sign a written informed consent form and is willing and able to comply with protocol requirements. 3. Is considered likely to meet the detailed inclusion and

Exclusion Criteria

for treatment when required. Inclusion Criteria for treatment portion of study: 1. Has histopathologically confirmed locally advanced or metastatic solid tumor cancer (or lymphoma in Phase 1). The solid tumor cancer is further defined in some cohorts as: 1. Phase 1B monotherapy expansion cohort: Has melanoma, except uveal melanoma, and has previously received anti-PD-1/L1 therapy and is now not eligible for anti-PD-1 treatment in the judgement of the Investigator due to prior severe immune related adverse events, and has not received intervening cancer therapy since the anti-PD-1/L1 therapy. 2. Monotherapy Cohort M2:

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

๐Ÿ“‹

Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

200 participants

โšง

Gender

ALL

๐Ÿข

Sponsor

Linnaeus Therapeutics, Inc.

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Los Angeles

California

Location available
View Los Angeles location page
RECRUITING

New Haven

Connecticut

Location available
View New Haven location page
RECRUITING

Boston

Massachusetts

Location available
View Boston location page
RECRUITING

Albuquerque

New Mexico

Location available
View Albuquerque location page
RECRUITING

New York

New York

Location available
View New York location page
RECRUITING

New York

New York

Location available
View New York location page
RECRUITING

Philadelphia

Pennsylvania

Location available
View Philadelphia location page
RECRUITING

Philadelphia

Pennsylvania

Location available
View Philadelphia location page
RECRUITING

Houston

Texas

Location available
View Houston location page

๐Ÿ“ And 1 more location available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

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๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Find More Advanced Solid Tumors Trials by City

Browse all advanced solid tumors clinical trials in these cities โ€” not just this study.

Looking for Solid Tumor Cancer Treatment in Los Angeles?

Join others in California exploring innovative treatment options through clinical research

Solid Tumor Cancer Treatment Options in Los Angeles, California

If you're searching for Solid Tumor Cancer treatment in Los Angeles, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Los Angeles, New Haven, Boston and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Solid Tumor Cancer. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 200 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Solid Tumor Cancer?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Solid Tumor Cancer

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Solid Tumor Cancer Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT04130516. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.