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GC4711 +SBRT

Placebo +SBRT

Eugene P Kennedy, MD

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.

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.

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

Phase 2 is a randomized, placebo-controlled study

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

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)

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.

Galera Therapeutics, Inc.

Subjects in Phase 1 received 100mg of GC4711 by 15 min IV prior to each administration of SBRT. SBRT was administered as a dose of 10-12 Gy per fraction in a total of 5 fractions within 10 calendar days.

Phase 1

Subjects in Phase 2 received Placebo by a 15 min IV prior to each administration of SBRT. SBRT was administered as a dose of 10-12 Gy per fraction in a total of 5 fractions within 10 calendar days.

Phase 2 Placebo +SBRT

Subjects in Phase 2 received 100mg of GC4711 by 15 min IV prior to each administration of SBRT. SBRT was administered as a dose of 10-12 Gy per fraction in a total of 5 fractions within 10 calendar days.

Phase 2 GC4711 +SBRT

Subjects in Phase 2 received 100mg of Placebo by 15 min IV prior to each administration of SBRT. SBRT was administered as a dose of 10-12 Gy per fraction in a total of 5 fractions within 10 calendar days.

Total

< 65

>/= 65

65-74

>/=75

Age, Customized

Sex: Female, Male

Race (NIH/OMB)

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.

Judy Schnyder

CR-Complete Response

PR-Partial Response

SD-Stable Disease

PD-Progressive Disease

NE-Not Evaluable

Intent to Treat population includes all subjects enrolled/randomized to the study.

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