Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer (NCT03860272)
A Phase 1 Study of AGEN1181, an Fc-Engineered Anti-CTLA-4 Monoclonal Antibody as Monotherapy and in Combination With AGEN2034 (Balstilimab), an Anti-PD-1 Monoclonal Antibody, in Subjects With Advanced Cancer
🩺 Plain-English Summary (8th-Grade Level)
This study is an open-label, Phase 1, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) profiles of a novel fragment crystallizable (Fc)-engineered immunoglobulin G1 anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) human monoclonal antibody (botensilimab) monotherapy and in combination with an anti-programmed cell death protein-1 (PD-1) antibody (balstilimab), and to assess the maximum tolerated dose (MTD) in participants with advanced solid tumors. This study will also determine the recommended phase 2 dose (RP2D) of botensilimab monotherapy and in combination with balstilimab.
Who can join: Review the eligibility criteria below.
Location: HonorHealth Research Institute — Scottsdale, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (18 Sites)
- HonorHealth Research Institute — Scottsdale, Arizona
- City of Hope Comprehensive Cancer Center — Duarte, California
- The Angeles Clinic & Research Institute, a Cedars-Sinai Affiliate — Los Angeles, California
- University of Southern California Norris Comprehensive Cancer Center — Los Angeles, California
- UCLA Santa Monica Hematology Oncology — Los Angeles, California
- Saint John's Cancer Institute — Santa Monica, California
- University of Colorado — Aurora, Colorado
- Yale Cancer Center — New Haven, Connecticut
- University of Miami Sylvester Comprehensive Cancer Center — Miami, Florida
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- Dana-Farber Cancer Institute — Boston, Massachusetts
- Icahn School of Medicine at Mount Sinai — New York, New York
- Columbia University Medical Center — New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York
- Providence Portland Cancer Center — Portland, Oregon
- MD Anderson Cancer Center — Houston, Texas
- The University of Texas Health Science Center at San Antonio — San Antonio, Texas
- Royal Marsden Hospital NHS Foundation Trust — London,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Advanced Cancer
- Intrapleural Catheter Daily Versus Three Times a Week Drainage — Houston, Texas
- Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) Therapy for Patients With Advanced Cancer — Toronto, Ontario
- Meaning-Centered Intervention for Muslim Patients Who Are Being Treated for Advanced Cancer — New York, New York
- FS120 Phase 1/1b Study in Patients With Advanced Malignancies — New Haven, Connecticut
- First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer — Encinitas, California
- Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21) — Santa Rosa, California
Explore by condition: All Advanced Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.