US-based Celldex Therapeutics has started patient enrolment in a Phase I clinical trial of CDX-1140 being evaluated for the treatment of advanced solid tumours.
CDX-1140 is a fully human antibody that targets CD40, which is known to be an activator of immune response and exposed in many cancer cells.
Set to recruit about 105 subjects with recurrent, locally advanced or metastatic cancers, the Phase I trial will include a dose-escalation part designed to establish the maximum tolerated dose.
This part will investigate 0.01mg/kg to 3mg/kg dose levels of CDX-1140 once every four weeks until disease progression or intolerance.
The subsequent expansion part will assess the tolerability and biologic effects of selected CDX-1140 dose in certain tumour types.
Celldex Therapeutics executive vice-president and chief scientific officer Tibor Keler said: “CD40 has long been an important target for immunotherapy, as it plays a critical role in the activation of innate and adaptive immune responses, however, balancing systemic dosing and safety has proven elusive to date for CD40 targeted activating therapeutics.
“CDX-1140 is a unique, potent CD40 agonist that we believe has the potential to successfully balance systemic doses for good tissue and tumour penetration with an acceptable safety profile.”
The trial’s secondary objectives include safety, tolerability, pharmacodynamics, pharmacokinetics, immunogenicity, anti-tumour activity, objective response rate, clinical benefit rate, progression-free survival, duration of response and overall survival.
Upon successful completion of the Phase I trial, Celldex intends to evaluate CDX-1140 as an adjuvant treatment with other immunotherapies or standard cancer treatments.