Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced or Metastatic Clear Cell Renal Cell Carcinoma

Summary

This is a Phase 1b/2 study of AVB-S6-500 designed to evaluate the safety and efficacy of AVB-S6-500 in combination with cabozantinib, AVB-S6-500 in combination with cabozantinib and nivolumab and AVB-S6-500 monotherapy in subjects with advanced or metastatic clear cell renal cell carcinoma (ccRCC). The phase 1b portion of the study is open label and patients with advanced ccRCC who had progressed on or after at least one prior line of treatment will receive AVB-S6-500 + cabozantinib. Two dose levels will be evaluated. The Phase 2 portion of the study is open-label 3-part study to evaluate efficacy and tolerability of AVB-S6-500 + cabozantinib, AVB-S6-500 + cabozantinib + nivolumab, and AVB-S6-500 alone.

Timeline

Start

2021-02-26

Primary completion

2023-08-14

Completion

2023-08-14

Publications

• Beckermann KE, Shah NJ, Campbell MT, Haas NB, Nelson A, Ornstein MC, Mao S, Keshava-Prasad HS, Hammers H, Gao X, Gourdin T, George S, Hoimes CJ, Hussain A, Jonasch E, Rini BI, Voss MH. Phase 1b/2 study of batiraxcept alone and in combination with cabozantinib with or without nivolumab for advanced clear cell renal cell carcinoma. Oncologist. 2025 Jun 4;30(6):oyaf138. doi: 10.1093/oncolo/oyaf138.

Drugs

Indications