A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of ARR-002 in Adults with Locally Advanced or Metastatic Ovarian or Endometrial Cancer
Categories (click each to see list of all clinical trials associated with that category): FPBCC CTO Studies, Gyn/Onc (OB/GYNONC)
Current Status: Open
Phase: I
Principal Investigator: Moore, Kathleen
Contact Information:
Marnee Strege
+1 402-559-8155
marnee.strege@unmc.edu
Summary
Phase Ia
Primary:
- To evaluate the safety and tolerability of ARR-002 in PROC
- To determine the MTD and/or RDEs of ARR-002 in PROC- To characterize the PK of ARR-002 in PROC
- To evaluate the immunogenicity of ARR002 in PROC- To evaluate the preliminary antitumor activity of ARR-002 in PROC
Exploratory:
- To assess the impact of ARR-002 on the QT/QTc in PROC
- To evaluate correlation between exploratory biomarkers (eg, MUC16 and NaPi2b expression, CA125 levels in blood) and antitumor activity in PROC
Phase Ib
Primary:
- To further evaluate the safety and tolerability of ARR-002 in PROC and endometrial cancer
- To evaluate the preliminary antitumor activity of ARR-002 in PROC and endometrial cancer
- To determine the RP2D of ARR-002 in PROC and endometrial cancer
Secondary:
- To further evaluate the preliminary antitumor activity of ARR-002 in PROC and endometrial cancer
- To evaluate the immunogenicity of ARR-002 in PROC and endometrial cancer
- To characterize the PK of ARR-002 in PROC and endometrial cancer
Exploratory:
- To assess the impact of ARR-002 on the QT/QTc in PROC
- To evaluate correlation between exploratory biomarkers (eg, MUC16 and NaPi2b expression, CA125 levels in blood) and antitumor activity in PROC and endometrial cancer