The double blinded, placebo-controlled trial has been designed to evaluate the efficacy and safety of BXQ-350, along with modified FOLFOX7 (mFOLFOX7) and bevacizumab, in patients with recently diagnosed ASIST of the colon/rectum.
It will also assess whether the administration of the combination therapy may reduce chemotherapy induced peripheral neuropathy (CIPN).
This will allow participants to receive the total and planned mFOLFOX7 doses.
In the trial, all participants will receive BXQ-350 by intravenous (IV) infusion plus standard of care doses of mFOLFOX and bevacizumab.
Stage 1 of the study will be open label and Stage 2 will be blinded.
In Stage 1, participants at increasing dose levels of BXQ-350 will be enrolled for determining the dose for stage 2.
Participants in Stage 2 will receive BXQ-350 at the established Stage 1 dose or a placebo.
Bexion Pharmaceuticals president and CEO Scott Shively said: “Dosing our first patient in this trial is a major milestone for Bexion.
“BXQ-350 combined with its observed safety profile, potential efficacy, and possible neuropathy benefit makes BXQ-350 a worthwhile candidate to use in combination with standard of care treatment for mCRC to not only enhance the treatment of mCRC, but also to evaluate its ability to alleviate side effects related to CIPN.”
The company stated that the trial initially includes six sites, with expansion planned for up to 15 sites in the US.
BXQ-350 is a first-in-class biologic that comprises multifunctional, lysosomal activator protein, Saposin C, and a phosphatidylserine.
It showed pre-clinical antitumor effects in both in vitro and in vivo, mainly in brain, colorectal, and other solid tumours.