Condition: Advanced Solid Tumor Cancer · Sponsor: Calico Life Sciences LLC
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.
This description comes directly from the study's public registry record.
Nicole Director Clinical Operations · 650-754-6200 · info@calicolabs.com
Always discuss trial participation with your own doctor first.
| University of Arizona Cancer Center - Tucson /ID# 262698 | Tucson, Arizona, United States | Recruiting |
| Yale University School of Medicine /ID# 225707 | New Haven, Connecticut, United States | Recruiting |
| Johns Hopkins Hospital /ID# 254056 | Baltimore, Maryland, United States | Recruiting |
| Beth Israel Deaconess Medical Center /ID# 252009 | Boston, Massachusetts, United States | Recruiting |
| Dana-Farber Cancer Institute /ID# 249642 | Boston, Massachusetts, United States | Recruiting |
| University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 252010 | Ann Arbor, Michigan, United States | Recruiting |
| NYU Laura and Isaac Perlmutter Cancer Center - 34th Street /ID# 257869 | New York, New York, United States | Recruiting |
| Duke Cancer Center /ID# 251975 | Durham, North Carolina, United States | Recruiting |
| Carolina BioOncology Institute /ID# 225704 | Huntersville, North Carolina, United States | Completed |
| Perelman Center for Advanced Medicine /ID# 250188 | Philadelphia, Pennsylvania, United States | Recruiting |
| UPMC Hillman Cancer Ctr /ID# 225706 | Pittsburgh, Pennsylvania, United States | Recruiting |
| Lifespan Cancer Institute at Rhode Island Hospital /ID# 225705 | Providence, Rhode Island, United States | Recruiting |
+ 18 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04777994