TerminatedPhase 1 / Phase 2NCT04476797
Official study title

Phase I/II Study of SBRT and GC4711 for Centrally Located or Large NSCLC

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedGC4711 +SBRT and Placebo +SBRT

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 30, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?10 U.S. locations

Locations may change over time.

Who runs it?Galera Therapeutics, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Galera Therapeutics, Inc.
Interventions being studied
Drug: GC4711 +SBRT; Drug: Placebo +SBRT
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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).

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Banner MD Anderson Cancer Center at NCMCGreeley, Colorado
  • Banner McKee Medical CenterLoveland, Colorado
  • IACT HealthColumbus, Georgia
  • University of Iowa Hospitals and ClinicsIowa City, Iowa
  • Duke University Medical CenterDurham, North Carolina
  • University Hospitals Cleveland Medical CenterCleveland, Ohio
  • Gibbs Cancer Center & Research InstituteSpartanburg, South Carolina
  • Parkland Health and Hospital SystemDallas, Texas
  • The University of Texas Southwestern Medical CenterDallas, Texas
  • Cancer Care NorthwestSpokane, Washington

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 30, 2024. Always confirm current availability with the study team.

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