- The QUILT 502 trial is testing ImmunityBio's N-803 (ANKTIVA) in combination with the AdHER2DC investigational vaccine for endometrial cancer, a gynecological cancer with lower survival rates and limited effective post-second-line treatment.
- The AdHER2DC vaccine targets the HER2 protein, which is elevated in 30% of endometrial cancer.
- ANKTIVA, recently approved for BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ, is designed to activate the immune cells that kill tumor cells to provide long-term immune response.
- The Phase1/2 interventional study will enroll 60 participants with HER2-positive endometrial cancer (EC), who will also receive pembrolizumab and lenvatinib, two FDA approved drugs for endometrial cancer.
- The study is expected to be completed in 2026.
Immunotherapy company ImmunityBio, Inc. ((IBRX), today announced the opening of a clinical trial to study ANKTIVA (nogapendekin alfa inbakicept-pmln) together with the investigational AdHER2DC vaccine (autologous dendritic cells transduced with HER2 expressing adenovirus), in individuals with HER2-expressing endometrial cancer. It marks the latest trial involving ANKTIVA, the company's IL-15 superagonist immune enhancer, to evaluate ANKTIVA as an agent to replace the short-term activity of checkpoint inhibitor immunotherapies with long-term effectiveness. ANKTIVA was recently approved by the FDA for BCG-unresponsive non-muscle invasive bladder cancer CIS with or without papillary tumors.
This Phase 1/2 QUILT 502 trial (NCT06253494) sponsored by the National Cancer Institute, part of the National Institutes of Health, will study whether the AdHER2DC vaccine in combination with ANKTIVA, pembrolizumab (checkpoint inhibitor), and lenvatinib (kinase inhibitor) can be safely administered in combination and provide preliminary clinical efficacy before a larger, more definitive study.