ART-123 + Chemotherapy for Colorectal Cancer

Recruiting at54 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Veloxis Pharmaceuticals

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing ART-123 to see if it can help patients with advanced colorectal cancer who are already receiving specific chemotherapy drugs. The goal is to find out if ART-123 can make their treatment safer or more tolerable.

Research Team

Libbie McKenzie, MD FASN

Principal Investigator

Veloxis Pharmaceuticals

Eligibility Criteria

This trial is for adults over 18 with metastatic colorectal cancer and an ECOG performance status of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but ambulatory. Participants must have normal recent liver and kidney tests, agree to use effective contraception, and be able to consent. Excluded are those with a high bleeding risk, other cancers, active ulcers, hepatitis B, prior thrombomodulin alfa treatment or recent investigational drug use.

Inclusion Criteria

My cancer is a type of colon or rectum cancer that has spread to other parts.

I am fully active or can carry out light work.

Willingness of the patient and the sexual partner to use a highly effective contraceptive method during the course of the study

Exclusion Criteria

I have an active ulcer.

I am at high risk for bleeding.

Patient is pregnant (positive urine human chorionic gonadotropin) or breastfeeding or intends to get pregnant during the Treatment period

Treatment Details

Interventions

• Placebo (Other)
• Thrombomodulin Alfa (Anticoagulant)

Trial Overview The study is testing the safety of ART-123 when added to FOLFOX (a type of chemotherapy) plus Bevacizumab in treating metastatic colorectal cancer. Patients will either receive ART-123 or a placebo alongside their standard chemotherapy regimen to compare outcomes.

Participant Groups

Group I: Medium Dose Experimental Treatment 1 Intervention

Lyophilized ART-123 reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)"

Group II: Lowest Dose Experimental Treatment 1 Intervention

Lyophilized ART-123 reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)

Group III: Low Dose Experimental Treatment 1 Intervention

Lyophilized ART-123 reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)"

Group IV: Highest Dose Experimental Treatment 1 Intervention

Lyophilized ART-123 reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)"

Group V: High Dose Experimental Treatment 1 Intervention

Lyophilized ART-123 reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)"

Group VI: Placebo Placebo Group 1 Intervention

Lyophilized placebo reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)"

Who Is Running the Clinical Trial?

Veloxis Pharmaceuticals

Lead Sponsor

Trials

43

Recruited

3,200+