BXQ-350 in Newly Diagnosed Metastatic Colorectal Carcinoma

Study acronym: ASIST
StatusActive, Not Recruiting
PhasePhase 1/2
Started

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Trial flagged as At Risk
Primary completion moved at least 6 months later Apr 2026 → Nov 2026
See other at-risk trials from Bexion Pharmaceuticals, Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Apr 2026 to Nov 2026
    • Eligibility criteria expanded, about 58 words
    • Secondary endpoints: details revised at 5 of 8 entries
    • Site details revised at 1 of 12 sites
  2. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 15 to 12
    v8
  3. Re-verified, no change to tracked fieldsv7
  4. Study sites: 6 to 15
    • Collaborators: 1 to 2
    v6
  5. Study sites: 3 to 6
    • Start date changed from estimate of Nov 2022 to Jan 9, 2023
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    v4
  2. Start date: Aug 2022 to Nov 2022v3
  3. Start date: Apr 2022 to Aug 2022v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05322590
Lead Sponsor Bexion Pharmaceuticals, Inc.
Collaborators: ICON plc, CTI Clinical Trial and Consulting Services
Conditions
(from sponsor)		 Metastatic Colorectal Carcinoma, Neuropathy
Related terms Colorectal Neoplasms
Enrollment 195 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov