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disitamab vedotin + radiotherapy + PD-1 inhibitor + GM-CSF + IL-2

Development stage
Unknown
Lead developer
The Second Affiliated Hospital of Soochow University
Modality
Implantable Devices → Device-based Delivery → Drug Delivery Systems, Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics, Cytokines & Interferons → Recombinant Proteins and Enzymes
Administration
Intravenous
01

Overview

PRaG 3.0 is an investigational combination immunotherapy regimen being evaluated for the treatment of HER2-positive advanced refractory solid tumors. Developed as an investigator-initiated trial by the Second Affiliated Hospital of Soochow University, the regimen integrates disitamab vedotin (RC48-ADC)—a humanized anti-HER2 antibody conjugated to the cytotoxic payload monomethyl auristatin E (MMAE)—with hypofractionated radiotherapy, a PD-1/PD-L1 inhibitor, and the sequential administration of the cytokines GM-CSF and IL-2. The mechanism of action involves direct HER2-targeted cell killing and payload-mediated microtubule inhibition, complemented by radiotherapy-induced immunogenic cell death and immune checkpoint blockade. The sequential addition of GM-CSF and IL-2 is intended to further stimulate dendritic cell maturation and T-cell proliferation, creating a robust anti-tumor immune response in patients who have failed standard therapies.

Brand names
Aidixi
Other names
o-Second Affiliated Hospital of Soochow University-solid tumorPRaG 3.0 regimenPRaG3.0 regimenPRaG-3.0 regimendisitamab vedotin combination therapyRC48-ADC combination therapyRC-48-ADC combination therapyRC 48-ADC combination therapy
02

Targets

CSF2R (Granulocyte-macrophage colony-stimulating factor receptor)IL-2R (Interleukin-2/interleukin-15 receptor complex)PDCD1 (Programmed cell death protein 1 receptor)ERBB2 (Erb-b2 receptor tyrosine kinase 2)TUBB (Tubulin (alpha and beta subunits))

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