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Celldex begins Phase I/II trial of varlilumab-sunitinib combination to treat CC-RCC

US-based Celldex Therapeutics has started an open-label, Phase I/II safety and tolerability trial evaluating the investigational combination of varlilumab and sunitinib (Sutent) in patients with metastatic clear cell renal cell carcinoma (CC-RCC).

Varlilumab is the company’s fully human monoclonal agonist antibody that binds and activates CD27, a critical co-stimulatory molecule in the immune activation cascade.

The Phase I portion of the trial will evaluate the safety and tolerability of varlilumab at 0.3, 1.0 and 3.0mg/kg combined with sunitinib at 50mg to identify a recommended dose for the trial’s Phase II portion.

In both phases of the trial, varlilumab will be administered once every three weeks for up to eight six-week cycles. In each six-week cycle, sunitinib 50mg will be given orally once daily for four weeks followed by two weeks without administration.

Sunitinib, an oral, small-molecule, multi-targeted receptor tyrosine kinase (RTK) inhibitor, is approved by the US Food and Drug Administration (FDA) to treat advanced renal cell carcinoma (RCC), as well as certain advanced gastrointestinal stromal tumors and pancreatic neuroendocrine tumors.

Currently, varlilumab is being evaluated in four Phase I/II combination studies, and additional combination studies will be started later this year.

The company has selected Sunitinib as an investigational combination with varlilumab because it has showed the potential to modulate anti-tumor immunity and reverse immune suppression in the tumor microenvironment.

Celldex Therapeutics executive vice-president and chief medical officer Thomas Davis said: "A growing understanding of renal cell carcinoma tumor biology has suggested that sunitinib’s mechanism of action may result in immune system stimulation in this indication."

Sunitinib blocks the function of RTKs, of which several are implicated in tumor growth, angiogenesis and metastasis.

The Phase I/II trial is expected to include up to ten sites in the US and enroll around 60 patients.