A Phase I First-in-Human, Open-Label Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-901 as a Monotherapy and in Combination With Bevacizumab in Adult Subjects With Ovarian Cancer
Categories (click each to see list of all clinical trials associated with that category): FPBCC CTO Studies, Gyn/Onc (OB/GYNONC)
Current Status: Not open
Phase: I
Principal Investigator: Moore, Kathleen
Contact Information:
Marnee Strege
+1 402-559-8155
marnee.strege@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT07278336?term=NCT07278336&viewType=Card&rank=1#participation-criteria
Summary
Primary:
- To characterize the safety and tolerability of ABBV-901 as a monotherapy and in combination with bevacizumab in advanced OC.
- To establish maximum administered dose (MAD)/ maximum tolerated dose (MTD) and determine the recommended Phase II dose (RP2D) of ABBV-901 as a monotherapy and in combination with bevacizumab in advanced OC.
- To assess the efficacy of ABBV-901 in subjects enrolled in Parts 2 and 4 with advanced OC.
Secondary:
- To characterize the pharmacokinetics (PK) and immunogenicity of ABBV-901 as a monotherapy and in combination with bevacizumab.
- To evaluate CA-125 response rate for ABBV-901 in subjects with advanced OC