Last updated on June 2020

PEN-866 in Patients With Advanced Solid Malignancies

Brief description of study

Protocol PEN-866-001 is an open-label, multi-center, first-in-human Phase 1/2a study evaluating PEN-866 in patients with advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies.

Detailed Study Description

Phase 1 will employ an adaptive model guided with overdose control principle to make dose recommendations and estimate the maximum tolerated dose (MTD).

Phase 2a begins once all patients treated in Phase 1 have been assessed for safety and the Safety Review Committee (SRC) has reviewed all safety data and recommends continuing with Phase 2a. PEN-866 will be evaluated using the recommended Phase 2 dose identified by the SRC at the conclusion of Phase 1 based on the safety, tolerability, pharmacokinetic, and pharmacodynamics profile of PEN-866 during Phase 1.

Clinical Study Identifier: NCT03221400

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Recruitment Status: Open

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