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HomeLatest Pharma-NewsThe U.S. Food and Drug Administration (FDA) has cleared the Atreca’s Investigational...

The U.S. Food and Drug Administration (FDA) has cleared the Atreca’s Investigational New Drug (IND) application for first-in-human Phase 1b clinical trial of ATRC-101 in patients with solid tumors

Dec. 03, 2019:The U.S. Food and Drug Administration (FDA) has cleared the Atreca’s Investigational New Drug (IND) application for first-in-human Phase 1b clinical trial of ATRC-101 (monoclonal antibody) in patients with solid tumors in early 2020.

The Phase 1b trial will be an open-label, dose escalation, monotherapy trial with an adaptive 3+3 design and will register patients with a wide variety of solid tumor cancers (ovarian, non-small cell lung, colorectal, breast and acral melanoma).

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The antigenic target of ATRC-101 (ribonucleoprotein complex) is expressed on over 50% of patient samples for each tumor types. https://fda.einnews.com/pr_news/503880628/atreca-announces-fda-clearance-of-investigational-new-drug-application-for-atrc-101

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