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FDA Clears The Way For a Trial to Evaluate an Investigational Drug Plus Keytruda in Treatment of Solid Tumors


The early-stage trial, according to the investigational drug’s manufacturer, Adagene, is expected to take place across multiple sites in the United States and Asia Pacific.

The Food and Drug Administration (FDA) recently granted Adagene clearance to proceed with its phase 1b/2 clinical trial assessing the safety and efficacy of ADG126 — an anti-CTLA-4 monoclonal antibody — in combination with Keytruda (pembrolizumab) for the treatment of various advanced and metastatic solid tumors.

The trial, according to a news release from Adagene, is slated to take place across multiple sites in the United States and Asia Pacific.

“We are excited to initiate our clinical trial evaluating combination therapy with ADG126, which leverages SAFEbody precision masking technology to address toxicity limitations. This multi-regional trial of ADG126 with (Keytruda) also reflects our commitment to bringing highly differentiated therapies to cancer patients globally,” Adagene’s co-founder, CEO and Chairman, Peter Luo, said in the release.

The company noted in the release that the first patient enrolled onto the trial is expected to receive treatment with the study drugs soon.

Adagene representatives have not responded to a request asking which solid tumors the study seeks to treat as of this writing.

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