New Jersey-based Celldex Therapeutics recently announced the initiation of a Phase 1/2 clinical trial of glembatumumab vedotin in patients with squamous cell carcinoma. The study will focus on the safety and tolerability of the drug in patients expressing the tumor protein gpNMB.
Glembatumumab vedotin is a human monoclonal antibody linked to a compound that targets gpNMB. The drug is currently in several other Phase 1 or 2 clinical trials for various cancer forms. Earlier research has shown that gpNMB helps cancer cells to invade new tissue and metastasize. In breast cancer, levels of the protein have been linked to disease progression.
The current trial focuses on patients with unresectable stage 3b or 4 lung squamous cell carcinoma, which is advanced or metastatic. Another requirement for study inclusion is that patients need to have progressed on earlier platinum-based chemotherapy.
“While checkpoint inhibitor therapy has been an important development for patients with squamous cell lung cancer, the majority of patients still require new, effective treatment options—especially targeted therapies,” Thomas Davis, executive vice president and chief medical officer of Celldex Therapeutics, said in a press release.
“gpNMB, the target of glembatumumab vedotin, is strongly expressed in the vast majority of squamous cell lung cancers. Glembatumumab vedotin has consistently induced notable response rates in other difficult-to-treat cancers that overexpress gpNMB. We hope to elicit similar activity in squamous cell carcinoma and look forward to completing this study,” Davis added.
The trial, which is planned to include 10 study sites across the U.S., is composed of a Phase 1 dose-escalation study followed by a two-stage Phase 2 part. The drug will be administered once every three weeks until disease progresses, or patients develop intolerance.
Celldex plans to enroll about 20 patients in the first part of the Phase 2 study. If at least two of them show a response, complete or partial, another 15 patients might be enrolled into the second part. The main objective of the Phase 2 study will be to evaluate the efficacy of the drug against the tumor.
The study will be conducted by PrECOG, Celldex’s partner in the study who represents a research network established by the Eastern Cooperative Oncology Group.