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Phase I/II Study of SBRT and GC4711 for Centrally Located or Large NSCLC (GRECO-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04476797
Recruitment Status : Terminated (Development GC4711 was halted after the lead study in pancreatic cancer was stopped early due to meeting the requirements of a futility analysis)
First Posted : July 20, 2020
Results First Posted : April 3, 2024
Last Update Posted : April 3, 2024
Sponsor:
Information provided by (Responsible Party):
Galera Therapeutics, Inc.

Brief Summary:

GTI-4711-101 is a Phase I/II study of the safety of GC4711, its effect on in-field tumor response and its potential to reduce radiation-related pulmonary injury due to SBRT for lymph node negative (T1 to T3N0M0) peripheral or central localized (within 2cm of the proximal bronchial tree) NSCLC.

After an open-label, Phase 1, safety cohort of 5 subjects has been completed, a randomized, placebo-controlled Phase 2 portion of 66 subjects will be conducted.


Condition or disease Intervention/treatment Phase
SBRT NSCLC Non-metastatic Drug: GC4711 +SBRT Drug: Placebo +SBRT Phase 1 Phase 2

Detailed Description:

Subjects must be referred for SBRT with large peripheral lesions (>1cm-7cm) and/or central localized, node negative, non-metastatic NSCLC, and have an ECOG PS score of 0-3. Feasibility of SBRT is judged by the treating physician.

SBRT is planned for the tumor location as a dose of or 3 fractions of 18-20 Gy (Phase 2 only) or 5 fractions of 10-12 Gy. SBRT fractions will be given within 180 minutes from the end of the GC4711 or placebo infusion.

After completion of Phase I, a Phase II, randomized, placebo-controlled study will be initiated, wherein approximately 66 subjects referred for SBRT with early stage large and/or central localized NSCLC will be randomized in a 1:1 ratio to receive either GC4711 or placebo given intravenously (IV) over 15 minutes before each fraction of SBRT, beginning the day of the first fraction of SBRT and ending the last day of SBRT.

Subjects will be monitored for treatment emergent adverse events for 30 days post SBRT completion. Additionally, subjects will be monitored 90 days post-SBRT for all adverse events to evaluate acute toxicities, and monitored for 1-year post-SBRT completion for specific late toxicities.

In-field tumor response and overall survival will be evaluated through 24 months post SBRT completion.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: After the open label Phase 1 portion, subjects in the Phase2 portion will be randomized in a 1:1 ratio to receive GC4711 or placebo before each fraction of SBRT
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Phase 2 is a randomized, placebo-controlled study
Primary Purpose: Treatment
Official Title: GRECO-1: Phase I/II, Randomized, Placebo-Controlled Study of Stereotactic Body Radiation Therapy (SBRT) and GC4711 for Centrally Located or Large, Node-Negative Non-Small Cell Lung Cancer (NSCLC)
Actual Study Start Date : October 18, 2020
Actual Primary Completion Date : November 28, 2023
Actual Study Completion Date : November 28, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Manganese

Arm Intervention/treatment
Experimental: Phase 1 GC4711 + SBRT Drug: GC4711 +SBRT
15 minute IV Infusion prior to SBRT
Other Name: rucosopasem manganese

Placebo Comparator: Phase 2 Placebo + SBRT Drug: Placebo +SBRT
15 minute IV infusion prior to SBRT

Experimental: Phase 2 GC4711 +SBRT Drug: GC4711 +SBRT
15 minute IV Infusion prior to SBRT
Other Name: rucosopasem manganese




Primary Outcome Measures :
  1. Percent of Patients With a Complete Response or Partial In-field Tumor Response Based on the RECIST 1.1 Criteria Through 6 Months Following SBRT. [ Time Frame: 6 months, 12 months, 18 months and 24 months post SBRT and GC4711+Placebo ]
    Subjects were required to have a baseline CT (chest, abdomen, and pelvis) and then were re-assessed by the same imaging modality at 6 months, 12 months, 18 months, and 24 months following the administration of GC4711/Placebo +SBRT and compared to the previous best response using RECIST 1.1 criteria.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  4. ECOG performance status of 0-3.
  5. Node negative (T1 to T3N0M0), centrally located (within 2cm in all directions around the proximal bronchial tree, including ultra-central tumors, abutting the bronchial tree or trachea) or large (>1-7cm) Non-Small Cell Lung Cancer (NSCLC), judged acceptable for SBRT by the treating Investigator
  6. Adequate end-organ function, based on routine clinical and laboratory workup:

    1. ANC >1,000 cells/µl, Platelets ≥ 75,000 cells/µl, Hemoglobin ≥ 7.0 g/dl
    2. Serum creatinine ≤ 2 x ULN or calculated creatinine clearance ≥ 30 ml/min
    3. Total bilirubin ≤ 1.5 x ULN (or direct bilirubin below the ULN), AST and ALT ≤ 2.5 x ULN
  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 1cm or smaller
  3. Prior treatment with immunotherapy within 3 months prior to Day 1 dosing.
  4. Prior intra-thoracic radiotherapy or surgery with substantial overlap to planned 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. History of allergic reactions attributed to compounds of similar chemical or biologic composition to GC4711.
  8. 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.
  9. Participation in other clinical trials actively testing new anti-cancer treatments, unless previously written approval is provided by the Sponsor.
  10. 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.
  11. Female subjects who are pregnant or breastfeeding.
  12. Any other conditions that, in the Investigator's opinion, might indicate the subject to be unsuitable for the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04476797


Locations
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United States, Colorado
Banner MD Anderson Cancer Center at NCMC
Greeley, Colorado, United States, 80631
Banner McKee Medical Center
Loveland, Colorado, United States, 80538
United States, Georgia
IACT Health
Columbus, Georgia, United States, 31903
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
United States, South Carolina
Gibbs Cancer Center & Research Institute
Spartanburg, South Carolina, United States, 29303
United States, Texas
Parkland Health and Hospital System
Dallas, Texas, United States, 75235
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
United States, Washington
Cancer Care Northwest
Spokane, Washington, United States, 99218
Sponsors and Collaborators
Galera Therapeutics, Inc.
Investigators
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Study Chair: Eugene P Kennedy, MD Chief Medical Officer
  Study Documents (Full-Text)

Documents provided by Galera Therapeutics, Inc.:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Galera Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04476797    
Other Study ID Numbers: GTI-4711-101
First Posted: July 20, 2020    Key Record Dates
Results First Posted: April 3, 2024
Last Update Posted: April 3, 2024
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Galera Therapeutics, Inc.:
lymph node negative NSCLC
centrally located NSCLC
large NSCLC
SBRT
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Manganese
Trace Elements
Micronutrients
Physiological Effects of Drugs