Drug intelligence / Profile preview

daratumumab + nivolumab + TG01

Development stage
Unknown
Lead developer
Georgetown University
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Vaccines & Immunotherapeutics
Administration
Intravenous, Intradermal
01

Overview

This combination therapy is an experimental immunotherapeutic regimen being evaluated in a Phase 2 clinical trial (NCT04134559) led by Georgetown University. It consists of three distinct components: nivolumab, a monoclonal antibody that inhibits the programmed death-1 (PD-1) receptor to enhance T-cell mediated anti-tumor activity; daratumumab, a monoclonal antibody targeting CD38, which is utilized in this context to deplete immunosuppressive myeloid-derived suppressor cells (MDSCs) and regulatory T cells (Tregs) within the tumor microenvironment; and TG01, a peptide-based vaccine designed to stimulate a specific T-cell response against mutant KRAS proteins. The regimen is specifically targeted at patients with advanced non-small cell lung cancer (NSCLC) or pancreatic ductal adenocarcinoma (PDAC) who harbor KRAS mutations, aiming to leverage the synergy between checkpoint inhibition, myeloid cell modulation, and antigen-specific vaccination to overcome tumor-induced immunosuppression.

Brand names
DarzalexOpdivo
Other names
TG01 + Nivolumab + DaratumumabTG01/GM-CSF + Nivolumab + Daratumumab
02

Targets

CD38 (Cluster of Differentiation 38)PDCD1 (Programmed cell death protein 1 receptor)

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