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

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ClinicalTrials.gov Identifier: NCT04476797
Recruitment Status : Recruiting
First Posted : July 20, 2020
Last Update Posted : March 18, 2021
Sponsor:
Information provided by (Responsible Party):
Galera Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE July 15, 2020
First Posted Date  ICMJE July 20, 2020
Last Update Posted Date March 18, 2021
Actual Study Start Date  ICMJE October 18, 2020
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2020)
  • Number of dose-limiting toxicities during treatment and within 30 days post SBRT [ Time Frame: DLT 30 days post SBRT ]
    Phase 1
  • DLCO measured by RTOG scale 3 months after completion of SBRT compared to baseline [ Time Frame: DLCO 90 days post SBRT ]
    Phase 2
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1/2 Study of SBRT With or Without GC4711 for NSCLC
Official Title  ICMJE Phase 1/2 Study of Stereotactic Body Radiation Therapy (SBRT) With or Without GC4711 for Early Stage, Centrally Located or Large Non-Small Cell Lung Cancer (NSCLC)
Brief 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.
Detailed Description

Subjects must be referred for SBRT with large (>3cm) or central localized, node negative, non-metastatic NSCLC, and have an ECOG PS score of 0-3 to be considered for enrollment. Subjects with small peripheral lesions(≤3cm) are excluded, as the aim is to improve outcome in larger, central NSCLC carrying a higher risk of pneumonitis, as well as poorer local control. Feasibility of SBRT is judged by the treating physician. Chemotherapy given before SBRT is permitted, but subjects must be immunotherapy naive.

SBRT is planned on the (persistent) PET+ tumor location for a dose of 10-12 Gy in 5 fractions, delivered on sequential weekdays. In the Phase 1, 5 subjects will each receive GC4711 by 15-minute IV infusion, before each SBRT fraction After the Phase 1, a Phase 2, randomized, double-blind, placebo-controlled study phase will be initiated, wherein approximately 66 subjects referred for SBRT with early stage large or central localized NSCLC will be randomized in a 1:1 ratio to receive either GC4711 or placebo given intravenously (IV) before each fraction of SBRT.

All subjects will be evaluated for changes in the diffusion capacity of carbon monoxide (DLCO) and pneumonitis. All subjects will be followed for 12 months for treatment related adverse effects, disease control (Progression Free Survival (PFS), Overall Survival (OS), Distant Metastases (DM) rate and local control-(RECSIST 1.1), and quality of life (FACT-L) A Data Monitoring Committee will be established for the Phase 2 portion of the study to provide independent monitoring of safety given the blinded design.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • SBRT
  • NSCLC
  • Non-metastatic
Intervention  ICMJE
  • Drug: GC4711
    15 minute IV Infusion
  • Drug: Placebo
    15 minute IV infusion
Study Arms  ICMJE
  • Experimental: Arm A Active GC4711
    Intervention: Drug: GC4711
  • Placebo Comparator: Arm B Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 15, 2020)
71
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Melissa Brookes 610-725-1500 info@galeratx.com
Contact: Charlotte Moser, MD, PhD 610-725-1500 info@galeratx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04476797
Other Study ID Numbers  ICMJE GTI-4711-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Galera Therapeutics, Inc.
Study Sponsor  ICMJE Galera Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Charlotte Moser, MD, PhD VP, Clinical Development
PRS Account Galera Therapeutics, Inc.
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP