Actively Recruiting
Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid Tumors
Led by Exelixis · Updated on 2026-03-12
1314
Participants Needed
122
Research Sites
445 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect of biomarkers of zanzalintinib administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet) and nivolumab + relatlimab (triplet) in participants with advanced solid tumors. In the Expansion Stage, the safety and efficacy of zanzalintinib as monotherapy and in combination therapy will be further evaluated in tumor-specific Expansion Cohorts.
CONDITIONS
Official Title
Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with solid tumors that are unresectable, locally advanced, or metastatic
- For dose-escalation: solid tumors without effective or tolerable life-prolonging therapies
- Specific tumor types for expansion cohorts, including clear cell renal cell carcinoma, metastatic castration-resistant prostate cancer, urothelial carcinoma, non-clear cell renal cell carcinoma, hepatocellular carcinoma, non-small cell lung cancer, colorectal cancer, and head and neck squamous cell carcinoma
- Measurable disease per RECIST 1.1 for all expansion cohorts except one
- Archival or fresh tumor tissue available for certain cohorts
- Recovery to baseline or mild adverse events from prior treatments
- Karnofsky Performance Status of 70% or higher
- Adequate organ and marrow function
- Use of effective contraception for fertile participants and partners
- Females of childbearing potential must not be pregnant at screening
You will not qualify if you...
- Prior treatment with zanzalintinib for dose-escalation cohorts
- Prior treatment with study drugs except specific allowed prior therapies in some cohorts
- Recent use of kinase inhibitors, anticancer antibodies, or chemotherapy before study treatment
- Use of complementary medicines to treat the disease within 2 weeks
- Recent radiation therapy within specified timeframes
- Known untreated or unstable brain metastases
- Use of oral anticoagulants except specified types
- Live vaccines within 30 days before treatment
- Significant uncontrolled illness
- Prolonged QT interval on ECG
- Untreated adrenal insufficiency
- Pregnant or breastfeeding females
- Other active cancers within 2 years except certain low-risk tumors
- Specific prior therapies disallowed in some cohorts
- Tumor location exclusions in some cohorts
- Elevated troponin levels in specified cohorts
- Additional criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 122 locations
1
Exelixis Clinical Site #67
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Exelixis Clinical Site #1
Tucson, Arizona, United States, 85711
Actively Recruiting
3
Exelixis Clinical Site #123
Palo Alto, California, United States, 94304
Actively Recruiting
4
Exelixis Clinical Site #59
Santa Barbara, California, United States, 93463
Actively Recruiting
5
Exelixis Clinical Site #87
Littleton, Colorado, United States, 80124
Actively Recruiting
6
Exelixis Clinical Site #62
New Haven, Connecticut, United States, 06510
Actively Recruiting
7
Exelixis Clinical Site #49
Newark, Delaware, United States, 19713
Active, Not Recruiting
8
Exelixis Clinical Site #48
Celebration, Florida, United States, 34747
Actively Recruiting
9
Exelixis Clinical Site #11
Gainesville, Florida, United States, 32610
Actively Recruiting
10
Exelixis Clinical Site #78
Jacksonville, Florida, United States, 32224
Actively Recruiting
11
Exelixis Clinical Site #47
Miami, Florida, United States, 33136
Actively Recruiting
12
Exelixis Clinical Site #61
Plantation, Florida, United States, 33322
Actively Recruiting
13
Exelixis Clinical Site #8
Tampa, Florida, United States, 33612
Actively Recruiting
14
Exelixis Clinical Site #26
Chicago, Illinois, United States, 60612
Actively Recruiting
15
Exelixis Clinical Site #4
Indianapolis, Indiana, United States, 46250
Actively Recruiting
16
Exelixis Clinical Site #122
Louisville, Kentucky, United States, 40202
Actively Recruiting
17
Exelixis Clinical Site #14
Baltimore, Maryland, United States, 21201
Actively Recruiting
18
Exelixis Clinical Site #7
Boston, Massachusetts, United States, 02215
Actively Recruiting
19
Exelixis Clinical Site #65
Detroit, Michigan, United States, 48201
Actively Recruiting
20
Exelixis Clinical Site #13
Detroit, Michigan, United States, 48202
Actively Recruiting
21
Exelixis Clinical Site #68
Rochester, Minnesota, United States, 55905
Actively Recruiting
22
Exelixis Clinical Site #2
Omaha, Nebraska, United States, 68130
Actively Recruiting
23
Exelixis Clinical Site #5
Omaha, Nebraska, United States, 68130
Active, Not Recruiting
24
Exelixis Clinical Site #55
Las Vegas, Nevada, United States, 89052
Actively Recruiting
25
Exelixis Clinical Site #88
East Brunswick, New Jersey, United States, 08816
Actively Recruiting
26
Exelixis Clinical Site #105
Hackensack, New Jersey, United States, 07601
Actively Recruiting
27
Exelixis Clinical Site #60
New York, New York, United States, 10032
Actively Recruiting
28
Exelixis Clinical Site #6
New York, New York, United States, 10065
Actively Recruiting
29
Exelixis Clinical Site #76
Syracuse, New York, United States, 13210
Actively Recruiting
30
Exelixis Clinical Site #12
Durham, North Carolina, United States, 27710
Actively Recruiting
31
Exelixis Clinical Site #10
Cleveland, Ohio, United States, 44106
Actively Recruiting
32
Exelixis Clinical Site #51
Portland, Oregon, United States, 97239
Actively Recruiting
33
Exelixis Clinical Site #104
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
34
Exelixis Clinical Site #98
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
35
Exelixis Clinical Site #32
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
36
Exelixis Clinical Site #24
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
37
Exelixis Clinical Site #9
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
38
Exelixis Clinical Site #3
Nashville, Tennessee, United States, 37203
Actively Recruiting
39
Exelixis Clinical Site #46
Austin, Texas, United States, 78705
Actively Recruiting
40
Exelixis Clinical Site #111
Dallas, Texas, United States, 75246
Actively Recruiting
41
Exelixis Clinical Site #89
Dallas, Texas, United States, 75246
Actively Recruiting
42
Exelixis Clinical Site #73
Irving, Texas, United States, 75063
Actively Recruiting
43
Exelixis Clinical Site #50
Plano, Texas, United States, 75075
Actively Recruiting
44
Exelixis Clinical Site #70
Tyler, Texas, United States, 75601
Actively Recruiting
45
Exelixis Clinical Site #66
Charlottesville, Virginia, United States, 22903
Actively Recruiting
46
Exelixis Clinical Site #33
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
47
Exelixis Clinical Site #116
Albury, Australia, 2640
Actively Recruiting
48
Exelixis Clinical Site #35
Birtinya, Australia, 4575
Actively Recruiting
49
Exelixis Clinical Site #16
Brisbane, Australia, 4102
Actively Recruiting
50
Exelixis Clinical Site #42
Saint Leonards, Australia, 2065
Actively Recruiting
51
Exelixis Clinical Site #36
Sydney, Australia, 2109
Actively Recruiting
52
Exelixis Clinical Site #94
Graz, Austria, 8036
Actively Recruiting
53
Exelixis Clinical Site #31
Salzburg, Austria, 5020
Completed
54
Exelixis Clinical Site #29
Vienna, Austria, 1020
Actively Recruiting
55
Exelixis Clinical Site #106
Wein, Austria, 1090
Actively Recruiting
56
Exelixis Clinical Site #39
Anderlecht, Belgium, 1070
Actively Recruiting
57
Exelixis Clinical Site #37
Kortrijk, Belgium, 8500
Actively Recruiting
58
Exelixis Clinical Site #85
Besançon, France, 25030
Actively Recruiting
59
Exelixis Clinical Site #96
Bordeaux, France, 33000
Actively Recruiting
60
Exelixis Clinical Site #79
Caen, France, 14076
Actively Recruiting
61
Exelixis Clinical Site #118
Clermont-Ferrand, France, 63011
Actively Recruiting
62
Exelixis Clinical Site #109
Lyon, France, 69008
Withdrawn
63
Exelixis Clinical Site #92
Marseille, France, 13273
Actively Recruiting
64
Exelixis Clinical Site #64
Nice, France, 06189
Actively Recruiting
65
Exelixis Clinical Site #83
Paris, France, 75010
Actively Recruiting
66
Exelixis Clinical Site #91
Paris, France, 75015
Withdrawn
67
Exelixis Clinical Site #80
Rennes, France, 35042
Actively Recruiting
68
Exelixis Clinical Site #63
Saint-Herblain, France, 44805
Actively Recruiting
69
Exelixis Clinical Site #75
Strasbourg, France, 67200
Actively Recruiting
70
Exelixis Clinical Site #84
Vandœuvre-lès-Nancy, France, 54519
Actively Recruiting
71
Exelixis Clinical Site #115
Villejuif, France, 94805
Actively Recruiting
72
Exelixis Clinical Site #103
Essen, Germany, 45147
Actively Recruiting
73
Exelixis Clinical Site #113
Hamburg, Germany, 22763
Actively Recruiting
74
Exelixis Clinical Site #108
Heidelberg, Germany, 69120
Actively Recruiting
75
Exelixis Clinical Site #82
Herne, Germany, 44625
Actively Recruiting
76
Exelixis Clinical Site #93
Jena, Germany, 07747
Actively Recruiting
77
Exelixis Clinical Site #112
München, Germany, 81737
Completed
78
Exelixis Clinical Site #102
Nürtingen, Germany, 72622
Actively Recruiting
79
Exelixis Clinical Site #107
Trier, Germany, 54292
Actively Recruiting
80
Exelixis Clinical Site #95
Tübingen, Germany, 72076
Actively Recruiting
81
Exelixis Clinical Site #86
Beersheba, Israel, 8410101
Actively Recruiting
82
Exelixis Clinical Site #72
Haifa, Israel, 3109601
Actively Recruiting
83
Exelixis Clinical Site #52
Jerusalem, Israel, 9112001
Actively Recruiting
84
Exelixis Clinical Site #71
Petah Tikva, Israel, 4941492
Actively Recruiting
85
Exelixis Clinical Site #69
Tel Aviv, Israel, 6423906
Actively Recruiting
86
Exelixis Clinical Site #38
Ẕerifin, Israel, 7030000
Actively Recruiting
87
Exelixis Clinical Site #121
Ancona, Italy, 60020
Actively Recruiting
88
Exelixis Clinical Site #117
Bologna, Italy, 40138
Actively Recruiting
89
Exelixis Clinical Site #90
Florence, Italy, 50134
Actively Recruiting
90
Exelixis Clinical Site #101
Milan, Italy, 20132
Actively Recruiting
91
Exelixis Clinical Site #81
Milan, Italy, 20141
Actively Recruiting
92
Exelixis Clinical Site #40
Naples, Italy, 80131
Actively Recruiting
93
Exelixis Clinical Site #74
Ravenna, Italy, 48121
Actively Recruiting
94
Exelixis Clinical Site #30
Grafton, New Zealand, 1023
Actively Recruiting
95
Exelixis Clinical Site #45
Hamilton, New Zealand, 3204
Actively Recruiting
96
Exelixis Clinical Site #20
Bydgoszcz, Poland, 85-796
Actively Recruiting
97
Exelixis Clinical Site #28
Gdansk, Poland, 80-219
Actively Recruiting
98
Exelixis Clinical Site #34
Otwock, Poland, 05-400
Actively Recruiting
99
Exelixis Clinical Site #54
Poznan, Poland, 60-569
Actively Recruiting
100
Exelixis Clinical Site #114
Wroclaw, Poland, 53-413
Actively Recruiting
101
Exelixis Clinical Site #41
Badajoz, Spain, 06080
Actively Recruiting
102
Exelixis Clinical Site #53
Barcelona, Spain, 08035
Actively Recruiting
103
Exelixis Clinical Site #15
Barcelona, Spain, 08036
Actively Recruiting
104
Exelixis Clinical Site #27
Barcelona, Spain, 08041
Actively Recruiting
105
Exelixis Clinical Site #120
L'Hospitalet de Llobregat, Spain, 08908
Actively Recruiting
106
Exelixis Clinical Site #57
Madrid, Spain, 28033
Actively Recruiting
107
Exelixis Clinical Site #43
Madrid, Spain, 28034
Actively Recruiting
108
Exelixis Clinical Site #58
Madrid, Spain, 28040
Actively Recruiting
109
Exelixis Clinical Site #77
Madrid, Spain, 28040
Actively Recruiting
110
Exelixis Clinical Site #19
Madrid, Spain, 28041
Actively Recruiting
111
Exelixis Clinical Site #100
Madrid, Spain, 28046
Actively Recruiting
112
Exelixis Clinical Site #18
Pamplona, Spain, 31008
Actively Recruiting
113
Exelixis Clinical Site #119
Santander, Spain, 39008
Actively Recruiting
114
Exelixis Clinical Site #23
Seville, Spain, 41013
Actively Recruiting
115
Exelixis Clinical Site #56
Valencia, Spain, 46010
Actively Recruiting
116
Exelixis Clinical Site #25
Valencia, Spain, 46026
Actively Recruiting
117
Exelixis Clinical Site #21
Chur, Switzerland, 7000
Completed
118
Exelixis Clinical Site #22
Sankt Gallen, Switzerland, 9007
Actively Recruiting
119
Exelixis Clinical Site #44
Winterthur, Switzerland, 8401
Actively Recruiting
120
Exelixis Clinical Site #110
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
121
Exelixis Clinical Site #99
London, United Kingdom, W6 8RF
Actively Recruiting
122
Exelixis Clinical Site #97
Middlesex, United Kingdom, HA6 2RN
Actively Recruiting
Research Team
E
Exelixis Clinical Trials
CONTACT
B
Backup or International
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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