Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer
Lay Description
This study is an open-label, Phase 1/2, multicenter study to evaluate the safety, tolerability, PK, and PD profiles of a novel Fc-engineered IgG1 anti-CTLA-4 human monoclonal antibody (AGEN1181) monotherapy and in combination with a human monoclonal IgG4 antibody (AGEN2034), and to assess the maximum tolerated dose (MTD) in subjects with advanced solid tumors. This study will also determine the RP2D of AGEN1181 monotherapy and in combination with AGEN2034.
Category
- Cancers and Other Neoplasms
- Solid Tumor
- IRB Number
- 20190051HU
- NCT Number
- NCT03860272
- Open to Enrollment
- Yes
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
Exclusion Criteria
Study Design
Arm Groups
Study Contact
Regulatory Point of Contact
Frances Crawford
(210) 450-5037
crawfordf1@uthscsa.edu
Regulatory Point of Contact
Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu
Regulatory Point of Contact
Daruka Mahadevan
(210) 450-1226
mahadevand@uthscsa.edu
Regulatory Point of Contact
Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu
Regulatory Point of Contact
Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu
Regulatory Point of Contact
Regulatory Staff
regaffstaff@uthscsa.edu
Regulatory Point of Contact
Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu
Regulatory Point of Contact
Benjamin Schleif
(210) 450-1366
schleifb@uthscsa.edu
Regulatory Point of Contact
Morgan Seekatz
(210) 450-1133
seekatz@uthscsa.edu
Principal Investigator
Daruka Mahadevan