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Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer

ABSTRACT: 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.

DISEASE(S): Endometrial Cancer,Melanoma,Hemangiosarcoma,Advanced Cancer,Endometrial Neoplasms,Angiosarcoma,Colorectal Cancer Without Liver Metastases,Neoplasms,Ovarian Cancer,Prostate Cancer,Non-small-cell Lung Cancer,Fibrolamellar Carcinoma,Solid Tumors

PROVIDER: 2298670 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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