BXQ-350 in Newly Diagnosed Metastatic Colorectal Carcinoma
Status:
Not yet recruiting
Trial end date:
2029-04-01
Target enrollment:
Participant gender:
Summary
The study will assess the safety and efficacy of BXQ-350 plus modified FOLFOX7 (mFOLFOX7) and
bevacizumab in participants who have newly diagnosed metastatic adenocarcinoma of the
colon/rectum. The study will also evaluate if the administration of BXQ-350 with mFOLFOX7 and
bevacizumab may diminish oxaliplatin induced sensory neurotoxicity, enabling participants to
receive the total and planned doses of mFOLFOX7.
All participants will receive BXQ-350 by intravenous (IV) infusion along with standard of
care doses of mFOLFOX and bevacizumab. The study is divided into two stages: Stage 1 will be
open label and will enroll participants at increasing dose levels of BXQ-350 in order to
determine the Stage 2 dose. Stage 2 will be blinded; participants will receive BXQ-350 at the
established Stage 1 dose or placebo.