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Small molecule

LNS8801 + Pembrolizumab for Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Linnaeus Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have adequate organ and bone marrow function defined by: Absolute neutrophil count >=1.5 × 109/L (>=1500/mm3), Hemoglobin >=9.0 g/dL or equivalent. Criteria must be met without packed red blood cell transfusion within the prior 2 weeks. Participants can be on a stable dose of erythropoietin (≥ 3 months), Platelet count >=75 × 10e9/L (>=75,000/mm3) for LNS8801 monotherapy cohorts Platelet count >=100 × 10e9/L (>=100,000/mm3) for LNS8801/pembrolizumab combination cohorts, Total bilirubin <=1.5 × institutional upper limit of normal (ULN), unless known Gilbert syndrome has been diagnosed, Measured or calculated creatinine clearance (glomerular filtration rate) >=50 mL/min/1.73 m2, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=2.5 × ULN or <=5 × ULN with cancer in the liver, For cohorts receiving LNS8801/pembrolizumab combination therapy, prothrombin time (PT) or activated partial thromboplastin time (aPTT) must be ≤1.5 × ULN. If a participant is receiving anticoagulant therapy, PT or aPTT must be within therapeutic range of intended use of anticoagulants.

Female patients must not be breastfeeding.

Must not have

Has a diagnosis of immunodeficiency, is on immunosuppressive therapy, or is receiving chronic systemic or enteric steroid therapy (in dosing exceeding 10 mg/day of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.

Has active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial tests a new drug called LNS8801 alone and with another drug, pembrolizumab, in patients with advanced cancers who haven't responded to other treatments or had severe side effects. LNS8801 targets and kills cancer cells directly, while pembrolizumab helps the immune system fight cancer.

Who is the study for?

Adults with advanced solid tumors, including specific types of lung and skin cancer, who have measurable disease and are in good physical condition. They must be able to swallow pills, not have certain infections or recent major surgeries, and agree to use effective contraception. Some cohorts require prior treatment history specifics.

What is being tested?

The trial is testing LNS8801 alone and combined with Pembrolizumab in patients with various solid tumors. It includes dose escalation to find the maximum tolerated dose (MTD) and expansion phases to assess safety, tolerability, pharmacokinetics (PK), and anti-tumor effects.

What are the potential side effects?

Potential side effects may include typical reactions associated with immunotherapies such as fatigue, digestive issues, skin reactions, potential for autoimmune-like conditions where the body's immune system attacks normal cells by mistake.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood counts and liver/kidney functions are within safe ranges for treatment.

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I am not currently breastfeeding.

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I have pancreatic, gastric, NSCLC, or colorectal cancer.

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My cancer progressed despite having multiple treatments with anti-PD-1/L1 therapy.

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My cancer can be measured on scans, and has grown even after radiation.

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I have no standard treatment options available or I choose not to pursue them.

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I am a male willing to use effective contraception or am surgically sterile.

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I have uveal melanoma with metastasis and have had 2 or fewer previous treatments.

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I have skin cancer (melanoma).

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I have uveal melanoma with metastasis and have had 2 or fewer previous treatments.

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My cancer is advanced or has spread to other parts of my body.

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My cancer is confirmed to be advanced or has spread to other parts.

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I can swallow pills.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am 18 years old or older.

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I have pancreatic, gastric, lung, or colorectal cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an immune system disorder or have been on strong immune-weakening medication recently.

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I have a condition that affects how my body absorbs medication.

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I do not have any active infections needing treatment.

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My heart's electrical cycle is within a safe range, and I don't use medications that could disrupt it.

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I have not had major surgery in the last 4 weeks.

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I have received an organ or tissue transplant from another person.

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I have symptoms from a brain tumor or cancer spread to my brain or spinal cord.

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I have lung inflammation or scarring.

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I am taking medication that affects liver enzymes.

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I stopped a cancer immunotherapy due to severe side effects.

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I have HIV, hepatitis B, or hepatitis C.

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I have an autoimmune disease treated with strong medication in the last 2 years.

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I need medication for stomach acid.

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My cancer is known to be estrogen receptor-positive.

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I have taken estrogen or estrogen-based contraceptives since my cancer diagnosis.

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My cancer was treated with hormone therapy targeting estrogen.

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I do not have any severe illnesses that my doctor says are uncontrolled.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

1Treatment groups

Experimental Treatment

Group I: ActiveExperimental Treatment2 Interventions

Phase 1/2 open-label

0 / 33Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,950 Previous Clinical Trials

5,174,783 Total Patients Enrolled

Linnaeus Therapeutics, Inc.Lead Sponsor

Tina Garyantes, PhDStudy DirectorLinnaeus Therapeutics, Inc.

Media Library

LNS8801 (Small molecule) Clinical Trial Eligibility Overview. Trial Name: NCT04130516 — Phase 1 & 2

Solid Tumors Research Study Groups: Active

Solid Tumors Clinical Trial 2023: LNS8801 Highlights & Side Effects. Trial Name: NCT04130516 — Phase 1 & 2

LNS8801 (Small molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04130516 — Phase 1 & 2

~34 spots leftby Sep 2025

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