Open-label, dose-escalating clinical trial of Survivin-responsive conditionally replicative adenovirus (Surv.m-CRA-1) by local administration to evaluate the safety / tolerability and preliminary efficacy in patients with advanced solid tumors (Phase I trial).

Phase 1

• Conditions: Advanced solid tumors for whom no standard therapy is available (primary malignant bone tumor, metastatic malignant bone tumor, primary malignant soft tissue tumor, metastatic malignant soft tissue tumor)

• Registration Number: JPRN-UMIN000023120
• Lead Sponsor: Department of Gene Therapy and Regenerative Medicine, Graduate School of Medical and Dental Sciences, Kagoshima university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-11
• Study Completion: 2019-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with the following illness: Severe heart disease, respiratory disease, digestive disease or liver disease. Uncontrolled diabetes Infectious disease that needs continuous treatment 2) A history of allergic reactions to penicillin, pork or beef (including milk) 3) Ongoing illness that requires immunosuppressant or corticosteroid administration 4) Currently active or past malignancies within the past five years 5) Uncontrollable fever or pain from the tumor 6) Pregnant, breast-feeding or woman with positive pregnancy test within 1 year after menopause. 7) Treated with non-approved drug within 4 weeks of study entry.

Study & Design

• Study Type: Interventional
• Study Design: Not specified