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Clinical Trial Summary

This is a two part Phase I/Ib, open-label, non-randomized and multi-center, dose escalation study with a 3+3 design (Part 1) and an expansion cohort at the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) (Part 2). If MTD is not reached in Part 1, RP2D will be determined after completion of Part 1 considering safety and tolerability, also beyond the dose limiting toxicity (DLT) period, pharmacokinetic (PK) and pharmacodynamic (PD) results.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03009214
Study type Interventional
Source amcure GmbH
Contact
Status Completed
Phase Phase 1
Start date December 2016
Completion date May 7, 2021

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