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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
No Placebo-Only Group
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 belowSelect...
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:Select...
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
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ActiveExperimental Treatment2 Interventions
Phase 1/2 open-label
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
4,015 Previous Clinical Trials
5,186,133 Total Patients Enrolled
Linnaeus Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
135 Total Patients Enrolled
Tina Garyantes, PhDStudy DirectorLinnaeus Therapeutics, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an immune system disorder or have been on strong immune-weakening medication recently.I agree to a biopsy if my tumor can be safely accessed.I haven't had cancer treatment in the last 4-6 weeks, except for specific immunotherapies.I am not currently breastfeeding.I have pancreatic, gastric, NSCLC, or colorectal cancer.My cancer progressed despite having multiple treatments with anti-PD-1/L1 therapy.My cancer can be measured on scans, and has grown even after radiation.I am not pregnant, confirmed by recent tests.My NSCLC has a PD-L1 score of 1-49%, no EGFR or ALK changes, and I haven't had PD-1/L1 blockers.I have no standard treatment options available or I choose not to pursue them.You can read and understand the information provided to you about the study and willingly agree to participate while following the study guidelines.I am willing to use effective birth control during and for 4 months after the study.I have melanoma, had severe side effects from anti-PD-1/L1 therapy, and haven't had other cancer treatments since.I am a male willing to use effective contraception or am surgically sterile.I have uveal melanoma with metastasis and have had 2 or fewer previous treatments.I have side effects from cancer treatment that haven't fully gone away, except for hair loss.I've had small-area radiation for symptom relief recently, not affecting over 30% of my bone marrow, and have recovered from side effects.I do not have any active infections needing treatment.My heart's electrical cycle is within a safe range, and I don't use medications that could disrupt it.I need or have recently had anti-TNF therapy like infliximab.I have a condition that affects how my body absorbs medication.I haven't had another active cancer besides my current one in the last 2 years, except for certain low-risk types or skin cancers.My blood counts and liver/kidney functions are within safe ranges for treatment.My cancer worsened after initially responding to anti-PD-1/L1 treatment without any other treatments in between.I have skin cancer (melanoma).I have not had major surgery in the last 4 weeks.I have received an organ or tissue transplant from another person.I had severe side effects from previous anti-PD-1/L1 therapy for my cancer and haven't had any other cancer treatment since.I have uveal melanoma with metastasis and have had 2 or fewer previous treatments.My cancer is advanced or has spread to other parts of my body.I am using, or have used, estrogen hormone replacement therapy since my diagnosis.I am not in another study and haven't used experimental treatments in the last 4 weeks.I have symptoms from a brain tumor or cancer spread to my brain or spinal cord.You are not currently participating in or have recently participated in another experimental treatment within the last month or 5 half-lives, whichever is shorter.I have skin cancer, was treated with anti-PD-1/L1, had severe side effects, and haven't had other cancer treatments since.I have lung inflammation or scarring.I am taking medication that affects liver enzymes.I stopped a cancer immunotherapy due to severe side effects.I have HIV, hepatitis B, or hepatitis C.I have an autoimmune disease treated with strong medication in the last 2 years.My cancer is confirmed to be advanced or has spread to other parts.I need medication for stomach acid.I can swallow pills.My cancer is known to be estrogen receptor-positive.I have thyroid or gall bladder cancer.I am fully active or restricted in physically strenuous activity but can do light work.I have not received a live vaccine in the last 30 days.I am 18 years old or older.I have not used specific hormone treatments for my current cancer, but I may have used birth control pills.You are expected to meet the specific requirements to participate in the study.I have taken estrogen or estrogen-based contraceptives since my cancer diagnosis.My cancer was treated with hormone therapy targeting estrogen.I've had lung radiation over 30 Gy in the last 6 months.I have pancreatic, gastric, lung, or colorectal cancer.You are expected to live for at least three more months.I do not have any severe illnesses that my doctor says are uncontrolled.
Research Study Groups:
This trial has the following groups:- Group 1: Active
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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