Study With ABBV-CLS-484 in Participants With Locally Advanced or Metastatic Tumors
Start Date
3/9/2021
Completion Date
10/1/2026
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
ABBV-CLS-484
Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitor (TKI)
Programmed Cell Death-1 (PD-1) Inhibitor
Conditions
Locations
University of Arizona Cancer Center - Tucson /ID# 262698
Tucson, Arizona 85724
United States
Yale University School of Medicine /ID# 225707
New Haven, Connecticut 06510
United States
Johns Hopkins Hospital /ID# 254056
Baltimore, Maryland 21287
United States
Beth Israel Deaconess Medical Center /ID# 252009
Boston, Massachusetts 02215-5400
United States
Dana-Farber Cancer Institute /ID# 249642
Boston, Massachusetts 02215
United States
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 252010
Ann Arbor, Michigan 48109
United States
NYU Laura and Isaac Perlmutter Cancer Center - 34th Street /ID# 257869
New York, New York 10016
United States
Duke Cancer Center /ID# 251975
Durham, North Carolina 27710
United States
Carolina BioOncology Institute /ID# 225704
Huntersville, North Carolina 28078
United States
Perelman Center for Advanced Medicine /ID# 250188
Philadelphia, Pennsylvania 19104
United States
UPMC Hillman Cancer Ctr /ID# 225706
Pittsburgh, Pennsylvania 15232
United States
Lifespan Cancer Institute at Rhode Island Hospital /ID# 225705
Providence, Rhode Island 02903-4923
United States
University of Texas Southwestern Medical Center /ID# 251974
Dallas, Texas 75390-7208
United States
University of Texas MD Anderson Cancer Center /ID# 252004
Houston, Texas 77030
United States
NEXT Oncology /ID# 225708
San Antonio, Texas 78229
United States
Institut Paoli-Calmettes /ID# 260956
Marseille, Bouches-du-Rhone 13009
France
IUCT Oncopole /ID# 252673
Toulouse, Occitanie 31059
France
Centre Antoine-Lacassagne /ID# 252606
Nice, Provence-Alpes-Côte d'Azur Region 06189
France
Hopital Foch /ID# 252607
Suresnes, 92151
France
Rabin Medical Center /ID# 263631
Petah Tikva, Central District 4941492
Israel
Hadassah Medical Center /ID# 252366
Jerusalem, Jerusalem 91120
Israel
The Chaim Sheba Medical Center /ID# 226756
Ramat Gan, Tel Aviv 5265601
Israel
National Cancer Center Hospital /ID# 225884
Chuo-ku, Tokyo 104-0045
Japan
Wakayama Medical University Hospital /ID# 252988
Wakayama, Wakayama 641-8510
Japan
Seoul National University Hospital /ID# 254635
Seoul, Seoul Teugbyeolsi 03080
South Korea
Samsung Medical Center /ID# 260664
Seoul, Seoul Teugbyeolsi 06351
South Korea
Yonsei University Health System Severance Hospital /ID# 260665
Seoul, 03722
South Korea
Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 252524
L'Hospitalet de Llobregat, Barcelona 08907
Spain
Hospital Universitario 12 de Octubre /ID# 257374
Madrid, Madrid 28041
Spain
Hospital Universitario HM Sanchinarro /ID# 228034
Madrid, Madrid 28050
Spain