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Monoclonal Antibodies

sEphB4-HSA with chemotherapy for Oral Squamous Cell Carcinoma

Phase 1
Waitlist Available
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13 weeks
Awards & highlights

Study Summary

This trial is testing a new cancer treatment combining a drug, radiation, and chemotherapy. They are trying to find the highest dose of the new drug that can be given safely with the other treatments.

Eligible Conditions
  • Oral Squamous Cell Carcinoma
  • Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 13 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The primary endpoint is whether a dose-limiting toxicity (DLT) occurs
Secondary outcome measures
Overall Survival
To assess the effect of adding sEphB4-HSA to radiation and cetuximab in newly-diagnosed EGFR-expressing LAHNSCC and heavy smoking histories on Disease Free Survival
To assess the effect of adding sEphB4-HSA to radiation and cetuximab in newly-diagnosed EGFR-expressing LAHNSCC and heavy smoking histories on Distant Control
+1 more
Other outcome measures
Genome

Trial Design

1Treatment groups
Experimental Treatment
Group I: sEphB4-HSA with CRTExperimental Treatment3 Interventions
sEphB4-HSA: Loading dose at fixed dose of 10mg/Kg per below schema on D1 Concurrent dose per below schema D15-43 and given on an every other week basis Concurrent chemotherapy drug (either cisplatin or carboplatin): Per treating physician discretion, and treatment plan is based per NCCN guidelines. These can be administered in tri-weekly or weekly doses during the radiation period. The participant will receive the first infusion on Day 15 (+/- 3 days). Cetuximab: Loading dose 400 mg/m2 on D9 Concurrent dose 250mg/m2 weekly D15± 3 day window RT: 6930 cGy IMRT starting D15-D18
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
sEphB4-HSA with chemotherapy
2020
Completed Phase 1
~10
Cetuximab
2011
Completed Phase 3
~2480
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

Vasgene Therapeutics, IncIndustry Sponsor
7 Previous Clinical Trials
303 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,732 Previous Clinical Trials
2,143,545 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
sEphB4-HSA With RT+Chemo or Cetux in Patients With Intermediate to High Risk LAHNSCC
2020. "sEphB4-HSA With RT+Chemo or Cetux in Patients With Intermediate to High Risk LAHNSCC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04091867.
~1 spots leftby Apr 2025
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