Trial of NanoPac Intratumoral Injection in Lung Cancer

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the use of NanoPac injected directly into tumors in the lung of people with lung cancer.

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

Details

• Lead Sponsor: NanOlogy, LLC
• Collaborator: US Biotest, Inc.
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

• Signed informed consent;

• Age ≥18 years and able to tolerate the EBUS-TBNI procedure;

• Histologically/cytologically confirmed lung cancer. Eligible subjects may include, for example: primary or recurrent non-resectable disease, locally advanced stages II and III with nodal disease, stage IV advanced disease;

• At least one lesion documented via imaging (within 4 weeks of Screening) which can be accessed using EBUS-TBNI;

• Subject is not a candidate for surgery;

• Has received SOC chemotherapy; adequate hematologic recovery must be confirmed according to the institution's SOC;

• Performance Status (ECOG) 0-2 at study entry;

• Life expectancy of at least 6 months;

• Adequate marrow, liver, and renal function at study entry;

• ANC ≥ 1.5 x 109/L;

• Hemoglobin ≥ 9.0 grams/dL;

• Platelets ≥ 75 x 109/L;

• Total bilirubin ≤ 1.5x institutional ULN;

• AST/ ALT ≤ 2.5x institutional ULN;

• Creatinine ≤ 1.5x institutional ULN;

• Appropriate steps taken to minimize or avoid the potential for pregnancy for subjects of child-bearing potential.*

Exclusion Criteria:

• Malignant Airway Obstruction;

• Known hypersensitivity to study agent;

• Pregnant or breastfeeding women.