Phase 2 Study of ADXS11-001 in Subjects With Carcinoma of the Anorectal Canal

• Status: Completed
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single arm Phase 2 study. Stage 1 and 2 of the study are monotherapy evaluations of ADXS11-001 in 31 and 24 subjects, respectively with persistent/recurrent, loco-regional or metastatic SCCA of the anorectal canal that have received at least 1 regimen for the treatment of advanced disease

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Advaxis, Inc.

Criteria

Inclusion Criteria:

• Must have cancer of the anal canal OR rectal cancer.

• Must have metastatic disease or persistent/recurrent loco-regional disease

• Prior Therapy: may have received <2 regimens for disease in the metastatic setting. At least one line of therapy.

• Be willing and able to provide written informed consent for the trial.

• Be ≥18 years of age on day of signing informed consent.

• Have measurable disease based on RECIST 1.1

• Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Demonstrate adequate organ function as defined in protocol.

• Females cannot be pregnant or breastfeeding and must take two methods of birth control