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Phase 1 Trials of Anti-enpp3 Antibody Drug Conjugates in Advanced Refractory Renal Cell Carcinomas

By June 13, 2018No Comments

To determine the safety, pharmacokinetics, and recommendedphase2 dose of an antibody drug conjugate (ADC) targeting ectonucleotide phosphodiesterases-pyrophosphatase 3 (ENPP3) conjugated to monomethyl auristatin F (MMAF) in subjects with advanced metastatic renal cell carcinoma (mRCC). Two phase 1 studies were conducted sequentially with 2 ADCs considered equivalent, hybridoma derived AGS-16M8F and Chinese Hamster Ovary derived AGS-16C3F. AGS-16M8F was administered intravenously every 3 weeks at 5 dose levels ranging from 0.6 to 4.8 mg/kguntil unacceptable toxicity or progression. The study was terminated before reaching the maximum tolerated dose (MTD). A second study with AGS-16C3F started with the AGS-16M8F bridging dose of 4.8 mg/kg given every 3 weeks.