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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months or until study completion
Awards & highlights

Study Summary

This trial is testing a new drug, LNS8801, to see if it is safe and works well against cancer. Up to 200 patients will be enrolled at up to 10 sites in the United States.

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.Check my eligibility
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.See study design
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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My cancer is confirmed to be advanced or has spread to other parts.
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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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months or until study completion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months or until study completion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determination of appropriate patient populations for future pivotal studies based on overall response rate (ORR) and clinical benefit rate (CBR) as assessed by RECISTv1.1
Determination of the MTD or RP2D of LNS8801 dosed alone and in combination with pembrolizumab
Secondary outcome measures
Clinical benefit rate (CBR) of LNS8801 alone or in combination
LNS8801 PK plasma exposure and calculated parameters
Overall response rate (ORR) for LNS8801 alone and when dosed in combination with pembrolizumab
+1 more
Other outcome measures
Change in target lesion growth rate before versus on study
OS, CBR, ORR, PFS in anti-PD-1 refractory patients
OS, CBR, ORR, PFS in patients with positive biomarkers (genetic, prolactin response, TILs, c-myc drop, etc)
+2 more

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
3,868 Previous Clinical Trials
5,051,835 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this an experimental treatment or has it been studied before?

"1000 different medical studies are currently underway to research this intervention. 122 of those trials have reached Phase 3 and the majority of them are based in Houston, Texas. However, there are 36030 total locations running these sorts of trials."

Answered by AI

How many people are included in the total sample size for this research?

"That is accurate. The information available on clinicaltrials.gov reveals that this research project is presently looking for volunteers. This trial was originally posted on October 21st, 2019 and was most recently edited on April 13th, 2022. A total of 200 individuals are needed at 8 different locations."

Answered by AI

Are there any positions available for participants in this research?

"That is correct. The information available on clinicaltrials.gov affirms that this trial, which was first advertised on October 21st 2019, is still recruiting patients. In total, they are hoping to enroll 200 individuals from 8 different medical facilities."

Answered by AI

What are the common reasons that patients receive this medication?

"This therapeutic intervention is most frequently used to ameliorate the effects of malignant neoplasms. In addition, it has been found to be an effective treatment for unresectable melanoma, microsatellite instability high and disease progression after chemotherapy."

Answered by AI

Are there different test sites for this experiment located throughout Canada?

"To limit travel-related stressors, patients are encouraged to choose the recruitment site that is closest to them. Currently, there are 8 sites enrolling individuals in this study: these locations include Philadelphia, San Antonio and Albuquerque amongst others."

Answered by AI
~0 spots leftby Mar 2024