Study of LYC-55716 With Pembrolizumab in Adult Subjects With Non-Small Cell Lung Cancer

Study summary

This is a Phase 1B study designed to assess the safety and tolerability of LYC-55716 given in combination with pembrolizumab to subjects with metastatic NSCLC, and to assess the combination for biologic and clinical activity in NSCLC.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedLYC-55716 and Pembrolizumab

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 25, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Unknown

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?4 U.S. locations

Locations may change over time.

Who runs it?Lycera Corp.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Lycera Corp.
Interventions being studied: Drug: LYC-55716; Drug: Pembrolizumab

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→

Treatment approach

Immunotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Subject has histologic or cytologic confirmation of metastatic NSCLC. Subjects must have a TPS score available as determined by an FDA approved test. Subject has stable disease or disease progression and is being treated with pembrolizumab therapy as standard of care by the Investigator.
Subject is male or female and at least 18 years of age.
Subject has at least 1 measurable lesion per RECIST v1.1 criteria by computed tomography (CT) scan or magnetic resonance image (MRI).
Subject provides consent for fresh paired tumor biopsy samples to be obtained at screening and after 4 weeks of treatment (not required for run-in cohort or expansion of run-in cohort).
Subject has a life expectancy of at least 12 weeks
Subject has adequate organ function as determined by the following laboratory values:
ANC\
≥ 1500/mm³ (≥ 1.5 x 10\^9/L)
Platelets\
≥ 100,000/mm³ (≥ 100 x 10\^9/L)
Lymphocytes\
≥ 500/mm³ (≥ 0.5 x 10\^9/L)
Hemoglobin\
≥ 9.0 g/dL
Serum Creatinine or Creatinine Clearance\*\
≤ 1.5 x ULN, \> 50 mL/min
Total Serum Bilirubin ≤ 1.5 x ULN (\< 3.0 mg/dL if subject has Gilbert's syndrome)
Liver Transaminases (ALT/AST) ≤ 2.5 x ULN, ≤ 5.0 x ULN if liver metastases present
(\
= without ongoing growth factor or transfusion support)
(\*\
= calculated by Cockcroft and Gault's formula)
(ALT = alanine aminotransferase, AST = aspartate aminotransferase, ULN = upper limit of normal)

Reasons someone may not be able to joinExclusion criteria

Subjects may not have genomic aberrations such as ALK, EGFR, or BRAF for which there are FDA-approved targeted therapies available. Subjects may not have ROS1 aberration in accordance with the pembrolizumab label.
Subject has received an investigational drug in the 28 day period before the first dose of study drug (or within 5 half-lives if longer) or is currently participating in another interventional clinical trial.
Subject has known symptomatic brain metastases or leptomeningeal involvement as assessed by CT scan or MRI. Subjects with stable asymptomatic brain metastases or leptomeningeal disease are eligible provided that they have not required new treatments for this disease in a 28 day period before the first dose of study drug, and anticonvulsants and steroids have not been administered for a period of 2 weeks prior to the first dose of study drug.
Subject has not recovered from adverse reactions to prior cancer treatment or procedures (surgery, chemotherapy, immunotherapy, radiation therapy) to CTCAE Grade 2 or better.
Subject has a previous (within 5 years) or current malignancy other than the target cancer with the exception of curatively treated local tumors such as carcinoma in situ of the breast or cervix, basal or squamous cell carcinoma of the skin, or prostate cancer with Gleason Grade \< 6 and prostate-specific antigen within normal range.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Lycera Investigational SiteAurora, Colorado
Lycera Investigational SiteAnn Arbor, Michigan
Lycera Investigational SiteNashville, Tennessee
Lycera Investigational SiteSeattle, Washington

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 25, 2019. Always confirm current availability with the study team.

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