Core Insights - Company Basilea Pharmaceutica announced the latest clinical progress of CS2009, a tri-specific antibody targeting PD-1, VEGF, and CTLA-4, with active patient recruitment in Australia and China, and plans to expand to the US for Phase II enrollment [1][2] Group 1: Clinical Trial Progress - The global multi-center Phase I/II clinical study of CS2009 is rapidly enrolling patients, with expectations to exceed 100 patients by the end of the year [1] - The Phase Ia dose-escalation study has completed assessments at four dose levels in patients with advanced solid tumors, with the fourth dose level (20 mg/kg every three weeks) showing no dose-limiting toxicities (DLT) [1] - The study is currently enrolling patients at the fifth dose level (30 mg/kg every three weeks) to observe safety beyond the recommended Phase II dose (RP2D) [1] Group 2: Safety and Efficacy Data - CS2009 has demonstrated good tolerability across all assessed dose levels, with pharmacokinetic (PK) characteristics supporting a three-week dosing regimen [2] - Pharmacodynamic (PD) data confirm that CS2009 triggers PD-1/CTLA-4 blockade, activating T cells and neutralizing VEGFA, with observed anti-tumor activity in "cold tumors" and PD-(L)1 treated patients in the low-dose group [2] - Phase Ia clinical data, including safety, PK, PD, and anti-tumor activity, is expected to be presented at an international academic conference in Q4 2025 [2] Group 3: Future Research Directions - The Phase Ib/II study is anticipated to start in the second half of 2025, focusing on dose expansion and key extension studies [1] - The trial will evaluate the clinical application value of CS2009 in various advanced solid tumors, including but not limited to non-small cell lung cancer, liver cancer, gastric cancer, endometrial cancer, ovarian cancer, renal cell carcinoma, colorectal cancer, and cervical cancer [2] - The aim is to advance innovative cancer immunotherapy development [2]
基石药业-B：目前CS2009在所有已评估的剂量水平上展现出良好的耐受性