drugset / Trial / NCT03860272
Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This study is an open-label, Phase 1, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) profiles of a novel fragment crystallizable (Fc)-engineered immunoglobulin G1 anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) human monoclonal antibody (botensilimab) monotherapy and in combination with an anti-programmed cell death protein-1 (PD-1) antibody (balstilimab), and to assess the maximum tolerated dose (MTD) in participants with advanced solid tumors. This study will also determine the recommended phase 2 dose (RP2D) of botensilimab monotherapy and in combination with balstilimab.
Timeline
- Start
- 2019-03-20
- Primary completion
- 2025-01-13
- Completion
- 2027-12
Publications
- Bengala E, Santini D, Picone V. Refractory microsatellite-stable metastatic colorectal cancer: a comparison between botensilimab + balstilimab and current standard of care. Immunooncol Technol. 2025 Nov 28;29:101558. doi: 10.1016/j.iotech.2025.101558. eCollection 2026 Mar.
- Wilky BA, Schwartz GK, Gordon MS, El-Khoueiry AB, Bullock AJ, Henick B, Agulnik M, Singh A, Mahadevan D, Stebbing J, Delepine C, Chand D, Avagyan M, Wu W, Johnson B, Grossman JE, O'Day S, Trent JC, Jones RL, Tsimberidou AM. Botensilimab (Fc-enhanced anti-cytotoxic lymphocyte-association protein-4 antibody) Plus Balstilimab (anti-PD-1 antibody) in Patients With Relapsed/Refractory Metastatic Sarcomas. J Clin Oncol. 2025 Apr 10;43(11):1358-1368. doi: 10.1200/JCO-24-02524. Epub 2025 Jan 27.
- Bullock AJ, Schlechter BL, Fakih MG, Tsimberidou AM, Grossman JE, Gordon MS, Wilky BA, Pimentel A, Mahadevan D, Balmanoukian AS, Sanborn RE, Schwartz GK, Abou-Alfa GK, Segal NH, Bockorny B, Moser JC, Sharma S, Patel JM, Wu W, Chand D, Rosenthal K, Mednick G, Delepine C, Curiel TJ, Stebbing J, Lenz HJ, O'Day SJ, El-Khoueiry AB. Botensilimab plus balstilimab in relapsed/refractory microsatellite stable metastatic colorectal cancer: a phase 1 trial. Nat Med. 2024 Sep;30(9):2558-2567. doi: 10.1038/s41591-024-03083-7. Epub 2024 Jun 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Balstilimab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Balstilimab | Monoclonal antibody | 450 mg | Intravenous |
| Subject | Botensilimab | Monoclonal antibody | 0.1 mg/kg | — |
| Subject | Botensilimab | Monoclonal antibody | 1 mg/kg | — |
| Subject | Botensilimab | Monoclonal antibody | 4 mg/kg | — |
| Subject | Botensilimab | Monoclonal antibody | 150 mg | — |