SIG001 / Guangzhou SIG Biomedical Technology - LARVOL DELTA

Preclinical pharmacokinetic modeling and clinical translation of SIG001, a novel anti-cancer therapeutic antibody targeting on cancer-derived sialylated IgG. (PubMed, Front Pharmacol) - "The preclinical investigations delineate the PK profile and antitumor activity of SIG001. The quantitative translation of animal data into human PK and exposure-response expectations provides a rational foundation for clinical development and supports informed decision-making in the design of early-phase trials."

First-in-human • Journal • PK/PD data • Preclinical • Oncology

A single-arm, open-label, dose-escalating and expansion Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of SIG001 in patients with advanced solid tumors (ChiCTR) - P1 | N=66 | Sponsor: Peking University Cancer Hospital; Guangzhou Aisaiji Biomedical Technology Co., Ltd.

New P1 trial • Oncology • Solid Tumor