A Phase I First-in-Human Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors
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
Eligibility: https://clinicaltrials.gov/study/NCT07470853?term=NCT07470853&viewType=Card&rank=1#participation-criteria
Summary
Primary:
- Evaluate the safety, tolerability, DLTs of HWK-016 as monotherapy (Part A) in participants with ovarian and endometrial cancers and in combination therapy with bevacizumab (Part B) in participants with ovarian cancer
- Identify the MTD or MAD and RDE(s) of HWK-016 as monotherapy (Part A) in participants with ovarian and endometrial cancers and in combination therapy with bevacizumab (Part B) in participants with ovarian cancer
Secondary:
- Characterize the PK of HWK-016 (ADC, total antibody, CPT116, and CPT119) (Part A and Part B)
- Assess ADA against HWK-016
- Evaluate preliminary antitumor activity of HWK-016 as monotherapy (Part A) in participants with ovarian and endometrial cancers and in combination therapy with bevacizumab (Part B) in participants with ovarian cancer by RECIST Version 1.1
Exploratory:
- Evaluate preliminary antitumor activity of HWK-016 as monotherapy (Part A) in participants with ovarian cancer and in combination therapy with bevacizumab (Part B) in participants with ovarian cancer by GCIG criteria
- Explore potential predictive biomarkers of response