Pilot Dose Escalation Trial of Stereotactic Body Radiation Therapy (SBRT) in Combination With GC4419 in Pancreatic Cancer

Summary

The purpose of the phase I/II clinical study is to determine the best dose of fractionated stereotactic radiation therapy (SBRT) given either with Avasopasem manganese (GC4419) or placebo to patients who have been diagnosed with locally advanced pancreatic cancer.

Timeline

Start

2018-02-12

Primary completion

2020-08-21

Completion

2021-05-26

Outcome

Met primary endpoint

paper At data cutoff (June 28, 2021), the avasopasem group satisfied boundaries for both efficacy and toxicity. PMID 38039992 ↗

Publications

• Results Hoffe S, Frakes JM, Aguilera TA, Czito B, Palta M, Brookes M, Schweizer C, Colbert L, Moningi S, Bhutani MS, Pant S, Tzeng CW, Tidwell RS, Thall P, Yuan Y, Moser EC, Holmlund J, Herman J, Taniguchi CM. Randomized, Double-Blinded, Placebo-controlled Multicenter Adaptive Phase 1-2 Trial of GC 4419, a Dismutase Mimetic, in Combination with High Dose Stereotactic Body Radiation Therapy (SBRT) in Locally Advanced Pancreatic Cancer (PC). Int J Radiat Oncol Biol Phys. 2020 Dec 1;108(5):1399-1400. doi: 10.1016/j.ijrobp.2020.09.022. Epub 2020 Nov 18. No abstract available.
• Taniguchi CM, Frakes JM, Aguilera TA, Palta M, Czito B, Bhutani MS, Colbert LE, Abi Jaoude J, Bernard V, Pant S, Tzeng CD, Kim DW, Malafa M, Costello J, Mathew G, Rebueno N, Koay EJ, Das P, Ludmir EB, Katz MHG, Wolff RA, Beddar S, Sawakuchi GO, Moningi S, Slack Tidwell RS, Yuan Y, Thall PF, Beardsley RA, Holmlund J, Herman JM, Hoffe SE. Stereotactic body radiotherapy with or without selective dismutase mimetic in pancreatic adenocarcinoma: an adaptive, randomised, double-blind, placebo-controlled, phase 1b/2 trial. Lancet Oncol. 2023 Dec;24(12):1387-1398. doi: 10.1016/S1470-2045(23)00478-3.
• Sishc BJ, Ding L, Nam TK, Heer CD, Rodman SN, Schoenfeld JD, Fath MA, Saha D, Pulliam CF, Langen B, Beardsley RA, Riley DP, Keene JL, Spitz DR, Story MD. Avasopasem manganese synergizes with hypofractionated radiation to ablate tumors through the generation of hydrogen peroxide. Sci Transl Med. 2021 May 12;13(593):eabb3768. doi: 10.1126/scitranslmed.abb3768.

Drugs

Indications