Celldex Therapeutics, Inc. (NASDAQ:CLDX) has started enrolling patients for its open-label, Phase 1 study of CDX-1140 used to treat patients with severe solid tumors. CDX-1140 is a human antibody which is mainly targeted to the CD40. CD40 is a major booster of the human immune system and is located on the dentritic cells, B cells and the macrophages. It is also found in many cancer cells.
In a statement, Celldex Therapeutics Executive Vice President and Chief Scientific Officer Tibor Keler, Ph.D said for a long period, CD40 has been a major target for immunotherapy. It plays an important role in activation adaptive and innate immune responses. However, it proved difficult to balance between safety and systematic dosing for CD40 targeted activating therapeutics. According to Keler, CDX-1140 is a unique and potent CD40 agonist with high potential to strike a balance between tumor penetration and systematic doses with acceptable safety profile.
The study is expected to admit around 105 patients with repeating metastatic or locally advanced cancers. The study has been designed to establish the maximum dose that can be tolerated during the phase of dose-escalation. Additionally, the study will recommend doses that will be subjected to further studies in subsequent expansion phases.
During the study, patients will be administered with CDX-1140 at doses ranging from 0.01 mg/kg to 3.0 mg/kg at least once in one week until disease intolerance or progression. The expansion phase has been developed to evaluate further the biological effects as well as the tolerability of some selected CDX-1140 doses in specific types of tumor.
Other secondary objectives of the study include establishing the tolerability, safety, pharmacokinetics, pharmacodynamics, immunogenicity as well as assessment of anti-tumor activity in several endpoints like clinical benefit rate, objective response rate, progression-free survival, duration of response and the overall survival rate.