What this means
This trial is testing whether a drug called ABBV-CLS-484 is safe and what dose works. It is still recruiting people, and no results have been posted yet.
Plain-English summary written by an AI model from the registry listing.
- Status
- Recruiting
- Who can join
- Ages 18 and over
- Where
- 30 sites, including Arizona, Connecticut, Maryland
The science
- Registered title
- Study With ABBV-CLS-484 in Participants With Locally Advanced or Metastatic Tumors
- Trial ID
- NCT04777994 ↗
- Phase
- PHASE 1
- Study type
- interventional
- Conditions
- Advanced Solid Tumor Cancer
- What is tested
- ABBV-CLS-484, Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitor (TKI), Programmed Cell Death-1 (PD-1) Inhibitor
- Sponsor
- Calico Life Sciences LLC
- Ages
- 18 Years to no maximum
- Dates
- First posted Mar 2, 2021 · updated Jun 4, 2026
Registry summary
The study will assess the safety, PK, PD, and preliminary efficacy of ABBV-CLS-484 as monotherapy and in combination with a PD-1 targeting agent or with a or a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI).
The trial aims to establish a safe, tolerable, and efficacious dose of ABBV-CLS-484 as monotherapy and in combination. The study will be conducted in three parts. Part 1 Monotherapy Dose Escalation, Part 2 Combination Dose Escalation and Part 3 Dose Expansion (Monotherapy and Combination therapy).
Part 1, ABBV-CLS-484 will be administered alone in escalating dose levels to eligible subjects who have advanced solid tumors.
Part 2, ABBV-CLS-484 will be administered at escalating dose levels in combination with a PD-1 targeting agent or with a VEGFR TKI to eligible subjects who have advanced solid tumors.
Part 3, ABBV-CLS-484 will be administered alone as a monotherapy at the determined recommended dose in subjects with locally advanced or metastatic, relapsed or refractory head and neck squamous cell carcinoma (HNSCC), relapsed or refractory non-small cell lung cancer (NSCLC), and advanced clear cell renal cell carcinoma (ccRCC). ABBV-CLS-484 will also be administered at the determined recommended dose in combination with a PD-1 targeting or with a VEGFR TKI agent in subjects with locally advanced or metastatic, HNSCC, NSCLC, MSI-H tumors refractory to PD-1/PD-L1, and advanced ccRCC.
Sites (30)
- University of Arizona Cancer Center - Tucson /ID# 262698, Tucson, Arizona, United States
- Yale University School of Medicine /ID# 225707, New Haven, Connecticut, United States
- Johns Hopkins Hospital /ID# 254056, Baltimore, Maryland, United States
- Beth Israel Deaconess Medical Center /ID# 252009, Boston, Massachusetts, United States
- Dana-Farber Cancer Institute /ID# 249642, Boston, Massachusetts, United States
- University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 252010, Ann Arbor, Michigan, United States
- NYU Laura and Isaac Perlmutter Cancer Center - 34th Street /ID# 257869, New York, New York, United States
- Duke Cancer Center /ID# 251975, Durham, North Carolina, United States
- Carolina BioOncology Institute /ID# 225704, Huntersville, North Carolina, United States
- Perelman Center for Advanced Medicine /ID# 250188, Philadelphia, Pennsylvania, United States
- UPMC Hillman Cancer Ctr /ID# 225706, Pittsburgh, Pennsylvania, United States
- Lifespan Cancer Institute at Rhode Island Hospital /ID# 225705, Providence, Rhode Island, United States
- University of Texas Southwestern Medical Center /ID# 251974, Dallas, Texas, United States
- University of Texas MD Anderson Cancer Center /ID# 252004, Houston, Texas, United States
- NEXT Oncology /ID# 225708, San Antonio, Texas, United States
And 15 more on the listing.
More aging trials in these states
Arizona · Connecticut · Maryland · Massachusetts · Michigan · New York · North Carolina · Pennsylvania · Rhode Island · Texas