A biopharma company developing microbiome therapeutics asked Alacrita to conduct a detailed protocol review of a clinical study designed for its lead asset in patients with advanced solid tumors including advanced melanoma, head and neck squamous cell cancer, and non-small cell lung cancer.


Alacrita's experienced clinical oncologist reviewed the study protocol and provided a detailed critical analysis of different aspects of the study design, providing extensive advice on changes to the protocol that would offer a more relevant and rational evaluation of the treatment plan in the target patient population. It was concluded that although the protocol was deemed feasible and would provide useful clinical and translational data, there were several structural issues with the study design which should be considered to reduce risk, including patient inclusion criteria, comparator arm, and choice of readout. Our findings were presented in a Word document and adopted by the client.



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