SBRTPhase 1/2GRECO-1NCT04476797
Phase I/II Study of SBRT and GC4711 for Centrally Located or Large NSCLC
A Phase 1/2 study testing GC4711 +SBRT in people with SBRT and NSCLC, run by Galera Therapeutics, Inc. at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SBRT, NSCLC, Non-metastatic
- What is being tested?
- GC4711 +SBRT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 10 sitesUnited States
- Study dates
- 18 Oct 2020to 28 Nov 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
IACT Health
Columbus, Georgia, 31903
Parkland Health and Hospital System
Dallas, Texas, 75235
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Duke University Medical Center
Durham, North Carolina, 27710
Banner MD Anderson Cancer Center at NCMC
Greeley, Colorado, 80631
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Banner McKee Medical Center
Loveland, Colorado, 80538
Gibbs Cancer Center & Research Institute
Spartanburg, South Carolina, 29303
Cancer Care Northwest
Spokane, Washington, 99218
About this study
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)
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.
Read the 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.
- Conditions
- SBRT, NSCLC, Non-metastatic
- Being tested
- GC4711 +SBRT, Placebo +SBRT
- Keywords
- lymph node negative NSCLC, centrally located NSCLC, large NSCLC, SBRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC4711 +SBRTDrug
Also called rucosopasem manganese
15 minute IV Infusion prior to SBRT
Placebo +SBRTDrug
15 minute IV infusion prior to SBRT
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 GC4711 + SBRT | Experimental | Not described Receives: Drug: GC4711 +SBRT |
| Phase 2 Placebo + SBRT | Placebo comparator | Not described Receives: Drug: Placebo +SBRT |
| Phase 2 GC4711 +SBRT | Experimental | Not described Receives: Drug: GC4711 +SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months, 12 months, 18 months and 24 months post SBRT and GC4711+Placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start18 Oct 2020
- Primary completion28 Nov 2023
- Study completion28 Nov 2023
Why it stopped: Development GC4711 was halted after the lead study in pancreatic cancer was stopped early due to meeting the requirements of a futility analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SBRTStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galera Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eugene P Kennedy, MD, Study chair, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476797
- Sponsor's protocol ID
- GTI-4711-101
- Acronym
- GRECO-1
- Status last verified
- Dec 2023
- First submitted
- 15 Jul 2020
- Last updated
- 30 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34145168
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04476797
- Acronym / sponsor ID
- GRECO-1 / GTI-4711-101
- Conditions
- SBRT, NSCLC, Non-metastatic
- Keywords
- lymph node negative NSCLC, centrally located NSCLC, large NSCLC, SBRT
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Development GC4711 was halted after the lead study in pancreatic cancer was stopped early due to meeting the requirements of a futility analysis
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Galera Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Oct 2020 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 20 Jul 2020 (actual)
- Results
- Posted 3 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GC4711 +SBRTAlso: rucosopasem manganese15 minute IV Infusion prior to SBRT | Drug | Phase 1 GC4711 + SBRT, Phase 2 GC4711 +SBRT |
| Placebo +SBRT15 minute IV infusion prior to SBRT | Drug | Phase 2 Placebo + SBRT |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34145168Squillace 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugene P Kennedy, MD study chair
Chief Medical Officer
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GC4711 +SBRT in people with SBRT and NSCLC, run by Galera Therapeutics, Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04476797, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.