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Study With ABBV-CLS-484 in Participants With Locally Advanced or Metastatic Tumors
Sponsor: Calico Life Sciences LLC
Summary
The study will assess the safety, PK, PD, and preliminary efficacy of ABBVCLS-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 ABBVCLS-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.
Official title: A Phase 1 Study With ABBV-CLS-484 Alone and in Combination in Subjects With Locally Advanced or Metastatic Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
248
Start Date
2021-03-09
Completion Date
2026-10
Last Updated
2025-12-23
Healthy Volunteers
No
Conditions
Interventions
ABBV-CLS-484
Oral Capsule
Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitor (TKI)
Oral Tablet
Programmed Cell Death-1 (PD-1) Inhibitor
Intravenous (IV) infusion
Locations (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
Institut Paoli-Calmettes /ID# 260956
Marseille, Bouches-du-Rhone, France
IUCT Oncopole /ID# 252673
Toulouse, Occitanie, France
Centre Antoine-Lacassagne /ID# 252606
Nice, Provence-Alpes-Côte d'Azur Region, France
Hopital Foch /ID# 252607
Suresnes, France
Rabin Medical Center /ID# 263631
Petah Tikva, Central District, Israel
Hadassah Medical Center /ID# 252366
Jerusalem, Jerusalem, Israel
The Chaim Sheba Medical Center /ID# 226756
Ramat Gan, Tel Aviv, Israel
National Cancer Center Hospital /ID# 225884
Chuo-ku, Tokyo, Japan
Wakayama Medical University Hospital /ID# 252988
Wakayama, Wakayama, Japan
Seoul National University Hospital /ID# 254635
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 260664
Seoul, Seoul Teugbyeolsi, South Korea
Yonsei University Health System Severance Hospital /ID# 260665
Seoul, South Korea
Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 252524
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario 12 de Octubre /ID# 257374
Madrid, Madrid, Spain
Hospital Universitario HM Sanchinarro /ID# 228034
Madrid, Madrid, Spain