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

• Status: Completed
• Trial end date: 2019-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lycera Corp.

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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