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Study of Cabozantinib Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
Sponsor: Exelixis
Summary
This is a multicenter Phase 1b, open-label study to assess safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of cabozantinib taken in combination with atezolizumab in subjects with multiple tumor types, including advanced urothelial carcinoma (UC) (including bladder, renal pelvis, ureter, urethra), renal cell carcinoma (RCC), castration-resistant prostate cancer (CRPC), non-small-cell lung cancer (NSCLC), triple negative breast cancer (TNBC), ovarian cancer (OC), endometrial cancer (EC), hepatocellular cancer (HCC), gastric cancer/gastroesophageal junction cancer/lower esophageal cancer (GC/GEJC/LEC), colorectal cancer (CRC), head and neck (H\&N) cancer, and differentiated thyroid cancer (DTC). The study consists of two stages: in the Dose Escalation Stage, an appropriate recommended cabozantinib dose for the combination with standard dosing regimen of atezolizumab will be established; in the Expansion Stage, tumor-specific cohorts will be enrolled in order to further evaluate the safety and efficacy of the combination treatment in these tumor indications. Three exploratory single-agent cabozantinib (SAC) cohorts may also be enrolled with UC, NSCLC, or CRPC subjects. One exploratory single-agent atezolizumab (SAA) cohort may also be enrolled with CRPC subjects. Subjects enrolled in the SAC cohorts and SAA cohort may receive combination treatment with both cabozantinib and atezolizumab after they experience radiographic progressive disease per the Investigator per RECIST 1.1. Due to the nature of this study design, some tumor cohorts may complete enrollment earlier than others.
Official title: A Phase 1b Dose-Escalation Study of Cabozantinib (XL184) Administered Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
914
Start Date
2017-09-05
Completion Date
2027-09-30
Last Updated
2025-08-17
Healthy Volunteers
No
Conditions
Interventions
cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.
atezolizumab
Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd
Locations (124)
Exelixis Clinical Site #53
Gilbert, Arizona, United States
Exelixis Clinical Site #18
Phoenix, Arizona, United States
Exelixis Clinical Site #1
Duarte, California, United States
Exelixis Clinical Site #20
La Jolla, California, United States
Exelixis Clinical Site #46
Los Angeles, California, United States
Exelixis Clinical Site #51
Newport Beach, California, United States
Exelixis Clinical Site #62
Santa Monica, California, United States
Exelixis Clinical Site #21
Stanford, California, United States
Exelixis Clinical Site #34
Denver, Colorado, United States
Exelixis Clinical Site #50
Denver, Colorado, United States
Exelixis Clinical Site #42
New Haven, Connecticut, United States
Exelixis Clinical Site #48
Washington D.C., District of Columbia, United States
Exelixis Clinical Site #16
Jacksonville, Florida, United States
Exelixis Clinical Site #76
Tampa, Florida, United States
Exelixis Clinical Site #60
Atlanta, Georgia, United States
Exelixis Clinical Site #79
Atlanta, Georgia, United States
Exelixis Clinical Site #32
Harvey, Illinois, United States
Exelixis Clinical Site #23
Fairway, Kansas, United States
Exelixis Clinical Site #57
Lexington, Kentucky, United States
Exelixis Clinical Site #24
New Orleans, Louisiana, United States
Exelixis Clinical Site #10
Boston, Massachusetts, United States
Exelixis Clinical Site #3
Detroit, Michigan, United States
Exelixis Clinical Site #17
Rochester, Minnesota, United States
Exelixis Clinical Site #65
Bolivar, Missouri, United States
Exelixis Clinical Site #43
Kansas City, Missouri, United States
Exelixis Clinical Site #35
Omaha, Nebraska, United States
Exelixis Clinical Site #59
Omaha, Nebraska, United States
Exelixis Clinical Site #61
Las Vegas, Nevada, United States
Exelixis Clinical Site #38
Camden, New Jersey, United States
Exelixis Clinical Site #27
East Brunswick, New Jersey, United States
Exelixis Clinical Site #31
New Brunswick, New Jersey, United States
Exelixis Clinical Site #40
East Setauket, New York, United States
Exelixis Clinical Site #11
New York, New York, United States
Exelixis Clinical Site #37
The Bronx, New York, United States
Exelixis Clinical Site #67
Cleveland, Ohio, United States
Exelixis Clinical Site #49
Columbus, Ohio, United States
Exelixis Clinical Site #64
Kettering, Ohio, United States
Exelixis Clinical Site #71
Oklahoma City, Oklahoma, United States
Exelixis Clinical Site #6
Oklahoma City, Oklahoma, United States
Exelixis Clinical Site #102
Portland, Oregon, United States
Exelixis Clinical Site #45
Portland, Oregon, United States
Exelixis Clinical Site #41
Bethlehem, Pennsylvania, United States
Exelixis Clinical Site #15
Philadelphia, Pennsylvania, United States
Exelixis Clinical Site #55
Philadelphia, Pennsylvania, United States
Exelixis Clinical Site #66
Pittsburgh, Pennsylvania, United States
Exelixis Clinical Site #95
Charleston, South Carolina, United States
Exelixis Clinical Site #13
Dallas, Texas, United States
Exelixis Clinical Site #26
Dallas, Texas, United States
Exelixis Clinical Site #114
Fort Worth, Texas, United States
Exelixis Clinical Site #29
Houston, Texas, United States
Exelixis Clinical Site #39
Houston, Texas, United States
Exelixis Clinical Site #44
Houston, Texas, United States
Exelixis Clinical Site #33
Lubbock, Texas, United States
Exelixis Clinical Site #63
San Antonio, Texas, United States
Exelixis Clinical Site #2
Salt Lake City, Utah, United States
Exelixis Clinical Site #30
Blacksburg, Virginia, United States
Exelixis Clinical Site #14
Charlottesville, Virginia, United States
Exelixis Clinical Site #98
Albury, New South Wales, Australia
Exelixis Clinical Site #101
Camperdown, New South Wales, Australia
Exelixis Clinical Site #115
Gosford, New South Wales, Australia
Exelixis Clinical Site #112
North Ryde, New South Wales, Australia
Exelixis Clinical Site #123
Randwick, New South Wales, Australia
Exelixis Clinical Site #99
St Albans, Victoria, Australia
Exelixis Clinical Site #52
Ghent, Belgium
Exelixis Clinical Site #54
Leuven, Belgium
Exelixis Clinical Site #88
La Roche-sur-Yon, Cedex 9, France
Exelixis Clinical Site #8
Villejuif, Cedex, France
Exelixis Clinical Site #92
Bordeaux, France
Exelixis Clinical Site #93
Brest, France
Exelixis Clinical Site #87
Caen, France
Exelixis Clinical Site #69
Le Mans, France
Exelixis Clinical Site #97
Lille, France
Exelixis Clinical Site #89
Lyon, France
Exelixis Clinical Site #109
Marseille, France
Exelixis Clinical Site #104
Nice, France
Exelixis Clinical Site #80
Nîmes, France
Exelixis Clinical Site #78
Paris, France
Exelixis Clinical Site #7
Paris, France
Exelixis Clinical Site #68
Paris, France
Exelixis Clinical Site #72
Paris, France
Exelixis Clinical Site #82
Saint-Grégoire, France
Exelixis Clinical Site #119
Strasbourg, France
Exelixis Clinical Site #107
Suresnes, France
Exelixis Clinical Site #105
Vandœuvre-lès-Nancy, France
Exelixis Clinical Site #56
Düsseldorf, North Rhine-Westphalia, Germany
Exelixis Clinical Site #36
Tübingen, Germany
Exelixis Clinical Site #84
Meldola, FC, Italy
Exelixis Clinical Site #47
Rozzano, Milano, Italy
Exelixis Clinical Site #108
Milan, Italy
Exelixis Clinical Site #103
Milan, Italy
Exelixis Clinical Site #25
Milan, Italy
Exelixis Clinical Site #4
Milan, Italy
Exelixis Clinical Site #85
Naples, Italy
Exelixis Clinical Site #121
Pavia, Italy
Exelixis Clinical Site #110
Roma, Italy
Exelixis Clinical Site #12
Nijmegen, Gelderland, Netherlands
Exelixis Clinical Site #74
Santiago de Compostela, A Coruña, Spain
Exelixis Clinical Site #91
Elche, Alicante, Spain
Exelixis Clinical Site #70
Palma de Mallorca, Balearic Islands, Spain
Exelixis Clinical Site #113
Badalona, Barcelona, Spain
Exelixis Clinical Site #116
Sabadell, Barcelona, Spain
Exelixis Clinical Site #96
Jeréz de La Frontera, Cádiz, Spain
Exelixis Clinical Site #90
Pamplona, Navarre, Spain
Exelixis Clinical Site #94
Oviedo, Principality of Asturias, Spain
Exelixis Clinical Site #117
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
Exelixis Clinical Site #75
Barcelona, Spain
Exelixis Clinical Site #58
Barcelona, Spain
Exelixis Clinical Site #83
Barcelona, Spain
Exelixis Clinical Site #86
Barcelona, Spain
Exelixis Clinical Site #28
Barcelona, Spain
Exelixis Clinical Site #9
Barcelona, Spain
Exelixis Clinical Site #73
Barcelona, Spain
Exelixis Clinical Site #118
Girona, Spain
Exelixis Clinical Site #77
Madrid, Spain
Exelixis Clinical Site #106
Madrid, Spain
Exelixis Clinical Site #111
Madrid, Spain
Exelixis Clinical Site #22
Madrid, Spain
Exelixis Clinical Site #5
Madrid, Spain
Exelixis Clinical Site #81
Madrid, Spain
Exelixis Clinical Site #100
Málaga, Spain
Exelixis Clinical Site #122
Middlesex, England, United Kingdom
Exelixis Clinical Site #120
Preston, England, United Kingdom
Exelixis Clinical Site #124
Cardiff, Wales, United Kingdom
Exelixis Clinical Site #19
London, United Kingdom