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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04476797
Recruitment Status : Recruiting
First Posted : July 20, 2020
Last Update Posted : July 21, 2023
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 Drug: Placebo 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)
Estimated Enrollment : 71 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
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: GC4711 + SBRT Drug: GC4711
15 minute IV Infusion prior to SBRT

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

Primary Outcome Measures :
  1. Number of dose-limiting toxicities during treatment and within 30 days post SBRT [ Time Frame: DLT 30 days post SBRT ]
    Phase 1

  2. Percent of patients with a best RECIST response of CR or PR amongst all responses through Month 6 [ Time Frame: 6 months post SBRT ]
    Phase 2

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT04476797

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Contact: Megan Holm 484-615-2036
Contact: Eugene P Kennedy, MD 484.870.9616

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United States, Arizona
Banner MD Anderson Cancer Center Withdrawn
Gilbert, Arizona, United States, 85234
United States, Colorado
Banner MD Anderson Cancer Center at NCMC Recruiting
Greeley, Colorado, United States, 80631
Contact: Supriya Jain, MD    970-810-6690      
Principal Investigator: Supriya Jain, MD         
Banner McKee Medical Center Recruiting
Loveland, Colorado, United States, 80538
Contact: Supriya Jain, MD    970-810-6690      
Contact: Kimberly Reyna    970-820-5982      
Principal Investigator: Supriya Jain, MD         
United States, Georgia
IACT Health Recruiting
Columbus, Georgia, United States, 31903
Contact: Douglas Ciuba, MD    706-596-5413      
Principal Investigator: Douglas Ciuba, MD         
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Sandy Vollstedt    319-353-7143      
Principal Investigator: Bryan Allen, MD         
United States, Kansas
University of Kansas Medical Center Withdrawn
Kansas City, Kansas, United States, 66160
United States, Michigan
Henry Ford Hospital Withdrawn
Detroit, Michigan, United States, 48208
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Heather Franklin    919-668-3726      
Contact: Linda Kaltenback    919-681-6804      
Principal Investigator: Christopher Kelsey, MD         
United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Tithi Biswas, MD    216-844-5336      
Principal Investigator: Tithi Biswas, MD         
United States, South Carolina
Gibbs Cancer Center & Research Institute Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Amy Curtis, MD    864-560-6954      
Principal Investigator: Amy Curtis, MD         
United States, Texas
Parkland Health and Hospital System Recruiting
Dallas, Texas, United States, 75235
Contact: Hector Gonzalez   
Principal Investigator: Kenneth Westover, MD         
The University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Hector Gonzalez   
Principal Investigator: Kenneth Westover, MD         
United States, Washington
Providence Regional Medical Center Withdrawn
Everett, Washington, United States, 98201
Cancer Care Northwest Recruiting
Spokane, Washington, United States, 99218
Contact: Orlan MacDonald, MD    509-228-1000      
Principal Investigator: Orlan MacDonald, MD         
Sponsors and Collaborators
Galera Therapeutics, Inc.
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Study Chair: Eugene P Kennedy, MD Chief Medical Officer
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Galera Therapeutics, Inc. Identifier: NCT04476797    
Other Study ID Numbers: GTI-4711-101
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: July 21, 2023
Last Verified: July 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
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
Lung Diseases
Respiratory Tract Diseases