Status:
UNKNOWN
Study of LYC-55716 With Pembrolizumab in Adult Subjects With Non-Small Cell Lung Cancer
Lead Sponsor:
Lycera Corp.
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 biolog...
Detailed Description
Approximately 18 subjects across 5 US sites will be enrolled in the study. Subjects will enter a screening period of up to 28 days, followed by continuous twice daily administration of LYC-55716 in 2...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
August 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2019
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03396497
Start Date
August 3 2018
End Date
October 20 2019
Last Update
September 25 2019
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Lycera Investigational Site
Aurora, Colorado, United States, 80045
2
Lycera Investigational Site
Ann Arbor, Michigan, United States, 48109
3
Lycera Investigational Site
Nashville, Tennessee, United States, 37203
4
Lycera Investigational Site
Seattle, Washington, United States, 98109