Aiming to Transform Radiation Therapy With Rucosopasem
- Rucosopasem manganese (GC4711) is a next-generation investigational selective dismutase mimetic infused over 15 minutes
- Rucosopasem is in development as a radiosensitizer in combination with stereotactic body radiation therapy (SBRT), with the goal of improving overall survival for patients
- Synergistic activity of selective dismutase mimetics was observed in combination with SBRT in preclinical models
- A pilot Phase 1/2 clinical trial conducted with a rucosopasem analogue appears to demonstrate acceptable safety in combination with SBRT, as well as suggesting improvements in overall survival, progression-free survival, locoregional control, and time to distant metastases
- Rucosopasem anticancer efficacy in combination with SBRT is being studied in pancreatic cancer and non-small cell lung cancer through the Galera Radiotherapy Efficacy Cancer Optimization (GRECO) clinical trial program
Pilot Trial Suggested Improvement in All Efficacy Endpoints for Pancreatic Cancer
- A pilot trial (N=42) of a rucosopasem analogue + SBRT versus placebo + SBRT following initial chemotherapy in patients with locally advanced pancreatic cancer found the combination to be well tolerated with similar tolerability profiles across arms. The addition of a selective dismutase mimetic to SBRT appears to demonstrate encouraging results in secondary and exploratory endpoints including overall survival, progression-free survival, locoregional control, and time to distant metastases.
- These findings supported the design of our Galera Radiotherapy Efficacy Cancer Optimization-2 (GRECO-2) clinical trial with rucosopasem.
- For more information related to this trial, please see the Galera corporate presentation on the Investors page.
Rucosopasem combined with SBRT is being studied as it may improve survival in patients with locally advanced pancreatic cancer.
GRECO-2: A Randomized, Phase 2b Study of Rucosopasem in Combination With Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Unresectable or Borderline Resectable Nonmetastatic Pancreatic Cancer1
- GRECO-2 is part of the Galera Radiotherapy Efficacy Cancer Optimization (GRECO) clinical trials program
- This is a multicenter, double-blind, placebo-controlled trial to determine the effect of rucosopasem on overall survival when added to SBRT following chemotherapy in patients with locally advanced pancreatic cancer
- GRECO-2 plans to enroll at least 160 patients randomized to receive rucosopasem or placebo in combination with SBRT
- The primary endpoint of the trial is to improve overall survival
- For more information, visit: NCT04698915
*Disease must remain non-metastatic after initial chemotherapy.
OS=overall survival; PFS=progression-free survival; SBRT=stereotactic body radiation therapy.
GRECO-1: Phase 1/2 Study of Stereotactic Body Radiation Therapy (SBRT) With or Without Rucosopasem for Early-Stage, Peripheral or Centrally Localized Non-Small Cell Lung Cancer (NSCLC)3
- GRECO-1 is a randomized, placebo-controlled, multicenter Phase 1/2 trial comparing the safety and efficacy of rucosopasem + SBRT to SBRT alone
- The trial plans to enroll 71 patients with peripheral or centrally localized NSCLC tumors without nodal or metastatic disease with the objective of improving outcomes for these patients
- For more information, visit: NCT04476797
For additional details on ongoing clinical trials, please visit clinicaltrials.gov.
- Clinicaltrials.gov. NCT04698915.
- Hoffe S, Kim D, Mafalda M, et al. GRECO-2: a randomized, phase 2 study of stereotactic body radiation therapy (SBRT) in combination with GC4711 in the treatment of unresectable or borderline resectable nonmetastatic pancreatic cancer (PC). Abstract presented at: 63rd Annual Meeting of the American Society for Radiation Oncology; October 24-27, 2021; Chicago, IL.
- Clinicaltrials.gov. NCT04476797.
Investigational Drug – Not for Commercial Distribution