Phase 1/2 Study of SBRT With or Without GC4711 for NSCLC

• Status: Recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

GTI-4711-101 is a Phase 1-2 study of the safety of GC4711, and its potential to reduce radiation-related pulmonary injury due to SBRT for early stage large or central localized NSCLC. After an open-label, Phase 1, safety cohort of approximately 5 subjects has been completed, a randomized, double-blind, placebo-controlled Phase 2 portion will be conducted.

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

Details

• Lead Sponsor: Galera Therapeutics, Inc.

Criteria

Inclusion Criteria:

1. Male or female subjects at least 18 years of age.

2. Ability to understand and the willingness to sign a written informed consent.

3. Histological or biopsy proven NSCLC. For peripheral lesions, cytology and/or clear imaging-guided suspicion is accepted if histology cannot be obtained.

4. ECOG performance status of 0-3.

5. Large (>3cm) or centrally localized (within 2cm in all directions around the proximal bronchial tree, including ultra-central tumors, abutting the bronchial tree or trachea), node negative and non-metastatic NSCLC, judged acceptable for SBRT by the treating Investigator. Staged with FDG-PET/CT, brain CT or MRI with contrast and/or mediastinoscopy, measurable disease as defined by RECIST 1.1.

6. Adequate end-organ function, based on routine clinical and laboratory workup:

1. ANC >1,000 cells/µl, Platelets ≥ 75,000 cells/µl, Hemoglobin ≥ 8.0 g/dl

2. Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 50 ml/min

3. Total bilirubin ≤ 1.5 x ULN (or direct bilirubin below the ULN), AST and ALT ≤ 2.5 x ULN

4. International normalized ratio (INR) (or prothrombin time (PT)) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy, if values are within the intended therapeutic range

7. Males and females of must agree to use effective contraception starting prior to the first day of treatment and continuing after the last dose of GC4711/Placebo for 30 days (females) and 90 days (males).

Exclusion Criteria:

1. Subjects with confirmed nodal and/or distant disease(including brain), according standard workup by local investigator

2. Subjects with peripheral lesions 3cm or smaller

3. Prior treatment with immunotherapy

4. Prior intra-thoracic radiotherapy or surgery with substantial overlap in former radiation fields as determined by the treating radiation oncologist.

5. Subjects not recovered/controlled from prior treatment-related (chemotherapy or targeted therapy) toxicities judged by treating physician.

6. Uncontrolled malignancy other than lung cancer that requires active treatment or is deemed by the treating physicians to be likely to affect the subject's survival duration.

7. Subjects unable to lie down with arms up with a regular breathing pattern.

8. History of allergic reactions attributed to compounds of similar chemical or biologic composition to GC4711.

9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.

10. Participation in other clinical trials either to treat diagnosed lung cancer or to reduce the toxicity of therapy from participating in GC4711 clinical trial.

11. Requirement for concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure.

12. Female subjects who are pregnant or breastfeeding.

13. Any other conditions that, in the Investigator's opinion, might indicate the subject to be unsuitable for the study.