Actively Recruiting
Dose-Escalation and Expansion Study of XL092 Combined With Immuno-Oncology Agents in Adults With Advanced or Metastatic Solid Tumors
Led by Exelixis · Updated on 2026-05-27
1314
Participants Needed
122
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, early antitumor activity, and biomarker effects of zanzalintinib alone and combined with immuno-oncology agents nivolumab, ipilimumab, and relatlimab in adults with advanced solid tumors. This Phase 1b, open-label, multicenter study includes a dose-escalation stage and tumor-specific expansion cohorts to further assess safety and efficacy of these treatments. Participants will receive zanzalintinib orally once daily. Depending on the study group, it may be combined with intravenous infusions of nivolumab every 3 or 4 weeks, ipilimumab every 3 weeks for up to four doses, or nivolumab combined with relatlimab administered intravenously. Dose-escalation cohorts enroll approximately 12 participants per dose level following a rolling 6 design, while expansion cohorts explore treatments further in specific tumor types. During the study, participants will be closely monitored for adverse events and immune-related side effects for up to 36 months. Researchers will assess tumor response rates, progression-free survival, overall survival, and duration of response over periods up to 24 months depending on cohort. Participants will have regular evaluations including scans, lab tests, and clinical assessments to track treatment effects and safety throughout the study and follow-up periods.
CONDITIONS
Brief 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 aged 18 years or older
- Confirmed unresectable, locally advanced, or metastatic solid tumor
- For dose-escalation: solid tumor with no effective or tolerable life-prolonging therapies
- Specific tumor types for expansion cohorts, including RCC, mCRPC, UC, nccRCC, HCC, NSCLC, CRC, HNSCC
- Measurable disease per RECIST 1.1 for most expansion cohorts
- Archival or fresh tumor tissue available for some cohorts
- Recovery to baseline or Grade 1 or less for prior treatment adverse events
- Karnofsky Performance Status of 70% or higher
- Adequate organ and marrow function
- Agreement to use highly effective contraception if fertile
- Females of childbearing potential must not be pregnant at screening
You will not qualify if you...
- Prior treatment with zanzalintinib for all cohorts
- Prior treatment with nivolumab, ipilimumab, or relatlimab except for specified cohorts and settings
- Recent use of small molecule kinase inhibitors within 2 weeks before study treatment
- Recent use of anticancer antibodies or chemotherapy within 4 weeks before study treatment
- Use of complementary medications for the disease within 2 weeks before study treatment
- Recent radiation therapy within specified timeframes before study treatment
- Known untreated or unstable brain metastases
- Use of oral anticoagulants except specified types
- Live attenuated vaccine within 30 days prior to study treatment
- Uncontrolled or significant recent illnesses
- QTc interval above specified thresholds
- Untreated adrenal insufficiency
- Pregnant or lactating females
- Other active malignancies within 2 years except certain low-grade or localized tumors
- Specific cohort restrictions on prior therapies or tumor subtypes
- Elevated troponin levels in certain cohorts
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 months
Participants receive Zanzalintinib orally once daily combined with immuno-oncology agents such as Nivolumab, Ipilimumab, or Relatlimab according to their assigned cohort.
IV infusions every 3 or 4 weeks with daily oral medication; visit frequency depends on assigned treatment schedule
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
Completed
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
B
Backup or International
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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