Advanced Ovarian Cancer Clinical Trial
Official title:
Phase 1, Open Label Study to Assess the Safety and Tolerability of U3 1565 in Subjects With Advanced Solid Malignant Tumors
This is a Phase 1, open label study to assess the safety and tolerability of U3 1565, determine maximum tolerated dose (MTD) or establish maximum administered dose (MAD) safety and tolerability.
This study will be conducted in 2 phases: a dose-escalation phase corresponding to Part 1
and a dose-expansion phase articulated in 2 concomitant parts (i.e., Parts 2a and 2b).
All parts of this study are single arm and open label. In all parts, tumor assessments will
be performed at screening and every 3 cycles thereafter, while the subject remains on study.
U3-1565 clinical activity will be assessed measuring tumor response by physical examination
and imaging according to RECIST version 1.1, if applicable.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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