Study of LYC-55716 in Adult Subjects With Locally Advanced or Metastatic Cancer

NCT02929862 | Completed Phase 1

• 1 other identifier: LYC-55716-1001
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 20

Brief Summary

This is a Phase 1/2A study designed to evaluate the safety and tolerability of increased repeated doses of LYC-55716 in subjects with locally advanced or metastatic solid tumors.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Assess Tumor Activity

  Evaluated according to RECIST v1.1

  8 weeks

Study Arms (1)

Single Agent 55716

EXPERIMENTAL

Drug: LYC-55716

Interventions

LYC-55716 DRUG

For Phase 1, increasing doses of oral 55716 given BID for a 28 day cycle. For Phase 2A, the RP2D will be administered to patients for 28 day cycles.

Single Agent 55716

Eligibility Criteria

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

You may qualify if:

• Subject is male or female and at least 18 years of age.
• Histological or cytological confirmation of advanced unresectable solid tumors, including those subjects who have progressed on standard anticancer therapy and for whom no further therapy that confers clinical benefit is available.
• Subject has an Eastern Cooperative Oncology Group (ECOG) score of 0 1 or Karnofsky Performance Status Score ≥ 70.
• Subject has a life expectancy of at least 12 weeks.
• Subject has adequate organ function as determined by the following laboratory values:
• Absolute Neutrophil Count\* ≥ 1,500/mm3 (≥ 1.5 x 109/L)
• Platelets\* ≥ 100,000/mm3 (≥ 100 x 109/L)
• Lymphocytes ≥ 0.5 x 109/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)

You may not qualify if:

• 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 if 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 Common Terminology Criteria for Adverse Events (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.
• Modifications to Eligibility Criteria for the following specific tumor types:
• Phase 2A will be limited to enrolling the following tumor types:
• NSCLC
• Gastric, Esophageal, and G-E Junction Adenocarcinoma
• SCCHN
• Ovarian Carcinoma
• Renal Cell Carcinoma
• Urothelial Carcinoma

Sponsors & Collaborators

• Lycera Corp.: lead

Study Sites (20)

Lycera Investigational Site

Huntsville, Alabama, 35805, United States

Location

Lycera Investigational Site

Sacramento, California, 95817, United States

Location

Lycera Investigational Site

Washington D.C., District of Columbia, 20007, United States

Location

Lycera Investigational Site

Sarasota, Florida, 34232, United States

Location

Lycera Investigational Site

Atlanta, Georgia, 30322, United States

Location

Lycera Investigational Site

Augusta, Georgia, 30912, United States

Location

Lycera Investigational Site

Chicago, Illinois, 60611, United States

Location

Lycera Investigational Site

Saint Cloud, Minnesota, 56303, United States

Location

Lycera Investigational Site

Omaha, Nebraska, 68130, United States

Location

Lycera Investigational Site

New York, New York, 10016, United States

Location

Lycera Investigational Site

Durham, North Carolina, 27710, United States

Location

Lycera Investigational Site

Oklahoma City, Oklahoma, 73104, United States

Location

Lycera Investigational Site

Portland, Oregon, 97213, United States

Location

Lycera Investigational Site

Philadelphia, Pennsylvania, 19111, United States

Location

Lycera Investigational Site

Greenville, South Carolina, 29605, United States

Location

Lycera Investigational Site

Nashville, Tennessee, 37203, United States

Location

Lycera Investigational Site

Dallas, Texas, 75230, United States

Location

Lycera Investigational Site

San Antonio, Texas, 78229, United States

Location

Lycera Investigational Site

Charlottesville, Virginia, 22908, United States

Location

Lycera Investigational Site

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

cintirorgon

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: October 5, 2016
• First Posted: October 11, 2016
• Study Start: December 1, 2016
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: September 25, 2019

Record last verified: 2018-05

Locations

US (20)