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ART-123 + Chemotherapy for Colorectal Cancer

Phase 1
Recruiting
Research Sponsored by Veloxis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Metastatic colorectal cancer; pathologically confirmed adenocarcinoma of the colon or rectum
18 years of age or older
Must not have
Active ulcer
High risk of hemorrhage
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1, day 1 and cycle 3, day 1 (each cycle is 14 days)
Awards & highlights

Summary

This trial is testing a new drug, ART-123, to see if it is safe and effective in treating metastatic colorectal cancer.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include increased risk of bleeding due to ART-123's effect on blood clotting; common chemo-related issues like nausea, fatigue, neuropathy; and Bevacizumab's risks such as hypertension and rare severe bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is a type of colon or rectum cancer that has spread to other parts.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an active ulcer.
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I am at high risk for bleeding.
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I have active Hepatitis B or tested positive for HBs antigen.
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I have had cancer before.
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I have had a major bleeding event in the past.
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I have been treated with thrombomodulin alfa before.
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I am currently taking blood thinners or clot-dissolving drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1, day 1 and cycle 3, day 1 (each cycle is 14 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1, day 1 and cycle 3, day 1 (each cycle is 14 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number and Percentage of Participants with Abnormal Coagulation Panel Results
Number and Percentage of Participants with Abnormal Complete Blood Count (CBC) Results
Number and Percentage of Participants with Abnormal Qualitative Urinalysis Results
+10 more
Secondary outcome measures
Plasma Concentrations of 5-fluorouracil (5-FU)
Plasma Concentrations of Oxaliplatin
Plasma Concentrations of Thrombomodulin
+1 more

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Medium DoseExperimental Treatment1 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 DoseExperimental Treatment1 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 DoseExperimental Treatment1 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 DoseExperimental Treatment1 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 DoseExperimental Treatment1 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: PlaceboPlacebo Group1 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)"

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Peripheral neuropathy treatments often target the underlying causes or symptoms of nerve damage. Common treatments include medications like anticonvulsants (e.g., gabapentin, pregabalin) and antidepressants (e.g., amitriptyline, duloxetine) which modulate nerve pain by altering neurotransmitter levels. Topical treatments like capsaicin and lidocaine patches provide localized pain relief by desensitizing pain receptors. For chemotherapy-induced peripheral neuropathy, agents like menthol and capsaicin patches are used to alleviate symptoms. ART-123, a recombinant thrombomodulin, modulates the coagulation pathway, which could potentially reduce inflammation and microvascular complications, thereby protecting nerve function. Understanding these mechanisms is crucial for peripheral neuropathy patients as it helps in selecting appropriate treatments that target specific pathways involved in their condition, potentially improving outcomes and quality of life.
Status of current clinical trials in diabetic polyneuropathy.

Find a Location

Who is running the clinical trial?

Veloxis PharmaceuticalsLead Sponsor
41 Previous Clinical Trials
3,066 Total Patients Enrolled
Aimee Liu, MD PhDStudy DirectorVeloxis Pharmaceuticals
Shailesh G. Chavan, MDStudy DirectorVeloxis Pharmaceuticals
1 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

thrombomodulin alfa Clinical Trial Eligibility Overview. Trial Name: NCT05251727 — Phase 1
Peripheral Neuropathy Research Study Groups: Placebo, Lowest Dose, High Dose, Highest Dose, Low Dose, Medium Dose
Peripheral Neuropathy Clinical Trial 2023: thrombomodulin alfa Highlights & Side Effects. Trial Name: NCT05251727 — Phase 1
thrombomodulin alfa 2023 Treatment Timeline for Medical Study. Trial Name: NCT05251727 — Phase 1
~25 spots leftby Jul 2025