A Study of AdAPT-001 in Subjects With Sarcoma and Refractory SolidTumors (BETA-PRIME)
Trial ID: NCT04673942
Phase: Phase 1/2
Status: Active but not recruiting
Last Verified: June 2026
Please Note: This trial is no longer enrolling new patients but remains active. Patients interested in similar approaches should speak with their oncologist or check clinicaltrials.gov for related open studies.
Eligibility: Adults aged 18 and older with advanced solid tumors, including synovial sarcoma, that have not responded to standard treatments. Patients must have tumors that can be directly injected and have adequate organ function.
Overview: This study tests AdAPT-001, a virus injected directly into tumors to attack cancer cells and wake up the immune system. The virus blocks a protein called TGF-β, which sarcoma tumors use to hide from the immune system and resist treatment. Some patients also receive a checkpoint inhibitor drug alongside the virus to further boost the immune response. The FDA has granted this treatment Fast Track designation.
Preliminary Effectiveness: Among 14 soft tissue sarcoma patients who received AdAPT-001 combined with a checkpoint inhibitor, 35.7% had an objective response and 69.2% reached three months without disease progression. Side effects have been mostly mild, including flu-like symptoms and injection site pain.
Treatment Centers:
United States
- MD Anderson Cancer Center, Houston, TX
- Cleveland Clinic, Cleveland, OH
- City of Hope, Duarte, CA
- California Cancer Associates for Research & Excellence, San Diego, CA
- Mary Crowley Cancer Research, Dallas, TX
- Saint John’s Cancer Institute at Providence Saint John’s Health Center, Santa Monica, CA