CS2009

Drug

Drug Profile

CS2009 is an investigational PD-1/VEGFA/CTLA-4 trispecific antibody developed by CStone for solid tumors. Clinical development has progressed through Phase I/II with more than 200 enrolled patients and ongoing preparation for Phase III multi-regional studies. The agent remains unapproved and in clinical development.

Drug Class
Trispecific antibody targeting PD-1, VEGFA, and CTLA-4
Approval Status
Investigational; IND-cleared with ongoing Phase I/II and planned Phase III trials, but not approved for marketing
Mechanism of Action
Combines anti-PD-1, anti-CTLA-4, and anti-VEGFA activities to reverse T-cell exhaustion, promote T-cell activation, inhibit angiogenesis, and remodel the tumor microenvironment
Indications
  • \Advanced solid tumors (investigational)\
  • \Non-small cell lung cancer (investigational)\
  • \Colorectal cancer (investigational)\

Related News

CStone Receives FDA Clearance to Advance CS2009 Trispecific Antibody to Phase II Trials

The FDA has cleared CStone Pharmaceuticals' investigational new drug application to begin a Phase II trial of its trispecific antibody CS2009 in advanced solid tumors. The multicenter trial will evaluate monotherapy and combination regimens across nine cancer types in Australia, China, and the U.S. Initial Phase I data showed a favorable safety profile and encouraging antitumor activity.

Related Clinical Trials

NCT ID Title Status Phase
NCT06741644

A Phase I/II Study of CS2009 in Participants With Advanced Solid Tumors

RECRUITING PHASE1/PHASE2