China-based RemeGen Ltd (SHA: 688331, HKG: 9995) has announced that it has received clinical trial approval for its novel bispecific antibody (BsAb), RC148. This development marks a significant step forward in the company’s efforts to address the complex challenges of treating multiple solid tumors.
RC148 Development and Phase I Study Design
RC148 is a bispecific antibody developed on RemeGen’s proprietary HiBody platform, with targets that remain undisclosed. The approved multicenter, open Phase I study is comprehensive in scope, designed to assess the safety, tolerability, maximum tolerable dose/maximum administration dose, pharmacokinetics (PK), pharmacodynamics, immunogenicity, phase II recommended dose, and preliminary anti-tumor efficacy of RC148.
Patient Enrollment and Study Focus
The main enrolled population for the study comprises patients with locally advanced unresectable or metastatic malignant solid tumors who have experienced disease progression after standard treatment, or who are intolerant to standard treatment, or lack standard treatment options. This study will provide crucial data on the potential of RC148 in treating patients with limited therapeutic options.-Fineline Info & Tech
