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

NCT03396497 | Unknown Phase 1 FDA Drug

• 1 other identifier: LYC-55716-1002
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 4

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 biologic and clinical activity in NSCLC.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability will be assessed by the number of subjects with any treatment-emergent Adverse Events

  Common terminology criteria for adverse events (CTCAE) will be used for AE assessment.

  12 weeks

Study Arms (1)

LYC-55716 + pembrolizumab

EXPERIMENTAL

Subjects will receive combination treatment until disease progression or unacceptable toxicity, or up to a maximum of 24 months.

Drug: LYC-55716; Drug: Pembrolizumab

Interventions

LYC-55716 DRUG

Continuous twice daily administration of LYC-55716 in 28 day treatment cycles.

LYC-55716 + pembrolizumab

Pembrolizumab DRUG

Pembrolizumab administered every 3 weeks as prescribed as standard of care by the investigator in accordance with the package insert.

LYC-55716 + pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lycera Corp.: lead

Study Sites (4)

Lycera Investigational Site

Aurora, Colorado, 80045, United States

Location

Lycera Investigational Site

Ann Arbor, Michigan, 48109, United States

Location

Lycera Investigational Site

Nashville, Tennessee, 37203, United States

Location

Lycera Investigational Site

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

cintirorgon; pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2018
• First Posted: January 11, 2018
• Study Start: August 3, 2018
• Primary Completion: October 20, 2019
• Study Completion: October 20, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

US (4)