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

NCT04476797 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: GTI-4711-101
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 10

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.

Conditions

SBRT; NSCLC; Non-metastatic

Keywords

lymph node negative NSCLC; centrally located NSCLC; large NSCLC; SBRT

Outcome Measures

Primary Outcomes (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.

  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.

  6 months, 12 months, 18 months and 24 months post SBRT and GC4711+Placebo

Study Arms (3)

Phase 1 GC4711 + SBRT

EXPERIMENTAL

Drug: GC4711 +SBRT

Phase 2 Placebo + SBRT

PLACEBO COMPARATOR

Drug: Placebo +SBRT

Phase 2 GC4711 +SBRT

EXPERIMENTAL

Drug: GC4711 +SBRT

Interventions

GC4711 +SBRT DRUG

15 minute IV Infusion prior to SBRT

Also known as: rucosopasem manganese

Phase 1 GC4711 + SBRT; Phase 2 GC4711 +SBRT

Placebo +SBRT DRUG

15 minute IV infusion prior to SBRT

Phase 2 Placebo + SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects at least 18 years of age.
• Ability to understand and the willingness to sign a written informed consent.
• Histological or biopsy proven NSCLC.
• ECOG performance status of 0-3.
• 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
• Adequate end-organ function, based on routine clinical and laboratory workup:
• ANC \>1,000 cells/µl, Platelets ≥ 75,000 cells/µl, Hemoglobin ≥ 7.0 g/dl
• Serum creatinine ≤ 2 x ULN or calculated creatinine clearance ≥ 30 ml/min
• Total bilirubin ≤ 1.5 x ULN (or direct bilirubin below the ULN), AST and ALT ≤ 2.5 x ULN
• 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).

You may not qualify if:

• Subjects with confirmed nodal and/or distant disease(including brain), according standard workup by local investigator
• Subjects with peripheral lesions 1cm or smaller
• Prior treatment with immunotherapy within 3 months prior to Day 1 dosing.
• Prior intra-thoracic radiotherapy or surgery with substantial overlap to planned radiation fields as determined by the treating radiation oncologist.
• Subjects not recovered/controlled from prior treatment-related (chemotherapy or targeted therapy) toxicities judged by treating physician.
• 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.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to GC4711.
• 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.
• Participation in other clinical trials actively testing new anti-cancer treatments, unless previously written approval is provided by the Sponsor.
• 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.
• Female subjects who are pregnant or breastfeeding.
• Any other conditions that, in the Investigator's opinion, might indicate the subject to be unsuitable for the study.

Sponsors & Collaborators

• Galera Therapeutics, Inc.: lead

Study Sites (10)

Banner MD Anderson Cancer Center at NCMC

Greeley, Colorado, 80631, United States

Location

Banner McKee Medical Center

Loveland, Colorado, 80538, United States

Location

IACT Health

Columbus, Georgia, 31903, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Gibbs Cancer Center & Research Institute

Spartanburg, South Carolina, 29303, United States

Location

Parkland Health and Hospital System

Dallas, Texas, 75235, United States

Location

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Cancer Care Northwest

Spokane, Washington, 99218, United States

Location

Related Publications (1)

• Squillace S, Salvemini D. Nitroxidative stress in pain and opioid-induced adverse effects: therapeutic opportunities. Pain. 2022 Feb 1;163(2):205-213. doi: 10.1097/j.pain.0000000000002347. No abstract available.

  PMID: 34145168 DERIVED

Limitations and Caveats

Study was terminated early by the Sponsor based on a the results of a futility analysis that was conducted on another program and the Sponsor decided to terminate the develop of GC4711. The last randomized subject did not complete protocol therapy but was followed for safety for a period of 30 days post the last administration of GC4711/Placebo +SBRT.

Results Point of Contact

• Title: Judy Schnyder
• Organization: Galera Therapeutics

jschnyder@galeratx.com

484-870-9625

Study Officials

• Eugene P Kennedy, MD

  Chief Medical Officer

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Phase 2 is a randomized, placebo-controlled study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 20, 2020
• Study Start: October 18, 2020
• Primary Completion: November 28, 2023
• Study Completion: November 28, 2023
• Last Updated: April 30, 2024
• Results First Posted: April 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)