RecruitingPhase 1NCT05176483

Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid Tumors

A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination With Immuno-Oncology Agents in Subjects With Unresectable Advanced or Metastatic Solid Tumors


Sponsor

Exelixis

Enrollment

1,314 participants

Start Date

Dec 14, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called zanzalintinib (which targets tumor blood vessel growth) combined with immunotherapy drugs in patients with various solid tumors that have spread or cannot be removed by surgery. Different patient groups include kidney cancer, prostate cancer, and others. **You may be eligible if:** - You have an advanced or metastatic solid tumor that cannot be surgically removed - For kidney cancer (clear cell type): you may qualify whether this is your first treatment or if prior immunotherapy plus targeted therapy has stopped working - For advanced prostate cancer: you have progressed during or after hormone therapy and have spread to other sites - You are in reasonably good health with adequate organ function **You may NOT be eligible if:** - You have had more than one prior line of systemic therapy for metastatic kidney cancer - You have active brain metastases (for some cohorts) - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZanzalintinib

Zanzalintinib orally once daily (qd)

DRUGNivolumab

360 mg IV infusion once every 3 weeks (q3w)

DRUGIpilimumab

1 mg/kg IV infusion once every 3 weeks (q3w) for maximum of four doses

DRUGNivolumab

3 mg/kg IV infusion once every 3 weeks (q3w) for first four doses, and then 480 mg IV infusion once every 4 weeks (q4w)

DRUGNivolumab

480 mg IV infusion once every 4 weeks (q4w)

DRUGNivolumab + Relatlimab

IV administration of nivolumab + relatlimab


Locations(122)

Exelixis Clinical Site #67

Phoenix, Arizona, United States

Exelixis Clinical Site #1

Tucson, Arizona, United States

Exelixis Clinical Site #123

Palo Alto, California, United States

Exelixis Clinical Site #59

Santa Barbara, California, United States

Exelixis Clinical Site #87

Littleton, Colorado, United States

Exelixis Clinical Site #62

New Haven, Connecticut, United States

Exelixis Clinical Site #49

Newark, Delaware, United States

Exelixis Clinical Site #48

Celebration, Florida, United States

Exelixis Clinical Site #11

Gainesville, Florida, United States

Exelixis Clinical Site #78

Jacksonville, Florida, United States

Exelixis Clinical Site #47

Miami, Florida, United States

Exelixis Clinical Site #61

Plantation, Florida, United States

Exelixis Clinical Site #8

Tampa, Florida, United States

Exelixis Clinical Site #26

Chicago, Illinois, United States

Exelixis Clinical Site #4

Indianapolis, Indiana, United States

Exelixis Clinical Site #122

Louisville, Kentucky, United States

Exelixis Clinical Site #14

Baltimore, Maryland, United States

Exelixis Clinical Site #7

Boston, Massachusetts, United States

Exelixis Clinical Site #65

Detroit, Michigan, United States

Exelixis Clinical Site #13

Detroit, Michigan, United States

Exelixis Clinical Site #68

Rochester, Minnesota, United States

Exelixis Clinical Site #2

Omaha, Nebraska, United States

Exelixis Clinical Site #5

Omaha, Nebraska, United States

Exelixis Clinical Site #55

Las Vegas, Nevada, United States

Exelixis Clinical Site #88

East Brunswick, New Jersey, United States

Exelixis Clinical Site #105

Hackensack, New Jersey, United States

Exelixis Clinical Site #60

New York, New York, United States

Exelixis Clinical Site #6

New York, New York, United States

Exelixis Clinical Site #76

Syracuse, New York, United States

Exelixis Clinical Site #12

Durham, North Carolina, United States

Exelixis Clinical Site #10

Cleveland, Ohio, United States

Exelixis Clinical Site #51

Portland, Oregon, United States

Exelixis Clinical Site #104

Hershey, Pennsylvania, United States

Exelixis Clinical Site #98

Philadelphia, Pennsylvania, United States

Exelixis Clinical Site #32

Pittsburgh, Pennsylvania, United States

Exelixis Clinical Site #24

Pittsburgh, Pennsylvania, United States

Exelixis Clinical Site #9

Myrtle Beach, South Carolina, United States

Exelixis Clinical Site #3

Nashville, Tennessee, United States

Exelixis Clinical Site #46

Austin, Texas, United States

Exelixis Clinical Site #111

Dallas, Texas, United States

Exelixis Clinical Site #89

Dallas, Texas, United States

Exelixis Clinical Site #73

Irving, Texas, United States

Exelixis Clinical Site #50

Plano, Texas, United States

Exelixis Clinical Site #70

Tyler, Texas, United States

Exelixis Clinical Site #66

Charlottesville, Virginia, United States

Exelixis Clinical Site #33

Milwaukee, Wisconsin, United States

Exelixis Clinical Site #116

Albury, Australia

Exelixis Clinical Site #35

Birtinya, Australia

Exelixis Clinical Site #16

Brisbane, Australia

Exelixis Clinical Site #42

Saint Leonards, Australia

Exelixis Clinical Site #36

Sydney, Australia

Exelixis Clinical Site #94

Graz, Austria

Exelixis Clinical Site #31

Salzburg, Austria

Exelixis Clinical Site #29

Vienna, Austria

Exelixis Clinical Site #106

Wein, Austria

Exelixis Clinical Site #39

Anderlecht, Belgium

Exelixis Clinical Site #37

Kortrijk, Belgium

Exelixis Clinical Site #85

Besançon, France

Exelixis Clinical Site #96

Bordeaux, France

Exelixis Clinical Site #79

Caen, France

Exelixis Clinical Site #118

Clermont-Ferrand, France

Exelixis Clinical Site #109

Lyon, France

Exelixis Clinical Site #92

Marseille, France

Exelixis Clinical Site #64

Nice, France

Exelixis Clinical Site #83

Paris, France

Exelixis Clinical Site #91

Paris, France

Exelixis Clinical Site #80

Rennes, France

Exelixis Clinical Site #63

Saint-Herblain, France

Exelixis Clinical Site #75

Strasbourg, France

Exelixis Clinical Site #84

Vandœuvre-lès-Nancy, France

Exelixis Clinical Site #115

Villejuif, France

Exelixis Clinical Site #103

Essen, Germany

Exelixis Clinical Site #113

Hamburg, Germany

Exelixis Clinical Site #108

Heidelberg, Germany

Exelixis Clinical Site #82

Herne, Germany

Exelixis Clinical Site #93

Jena, Germany

Exelixis Clinical Site #112

München, Germany

Exelixis Clinical Site #102

Nürtingen, Germany

Exelixis Clinical Site #107

Trier, Germany

Exelixis Clinical Site #95

Tübingen, Germany

Exelixis Clinical Site #86

Beersheba, Israel

Exelixis Clinical Site #72

Haifa, Israel

Exelixis Clinical Site #52

Jerusalem, Israel

Exelixis Clinical Site #71

Petah Tikva, Israel

Exelixis Clinical Site #69

Tel Aviv, Israel

Exelixis Clinical Site #38

Ẕerifin, Israel

Exelixis Clinical Site #121

Ancona, Italy

Exelixis Clinical Site #117

Bologna, Italy

Exelixis Clinical Site #90

Florence, Italy

Exelixis Clinical Site #101

Milan, Italy

Exelixis Clinical Site #81

Milan, Italy

Exelixis Clinical Site #40

Naples, Italy

Exelixis Clinical Site #74

Ravenna, Italy

Exelixis Clinical Site #30

Grafton, New Zealand

Exelixis Clinical Site #45

Hamilton, New Zealand

Exelixis Clinical Site #20

Bydgoszcz, Poland

Exelixis Clinical Site #28

Gdansk, Poland

Exelixis Clinical Site #34

Otwock, Poland

Exelixis Clinical Site #54

Poznan, Poland

Exelixis Clinical Site #114

Wroclaw, Poland

Exelixis Clinical Site #41

Badajoz, Spain

Exelixis Clinical Site #53

Barcelona, Spain

Exelixis Clinical Site #15

Barcelona, Spain

Exelixis Clinical Site #27

Barcelona, Spain

Exelixis Clinical Site #120

L'Hospitalet de Llobregat, Spain

Exelixis Clinical Site #57

Madrid, Spain

Exelixis Clinical Site #43

Madrid, Spain

Exelixis Clinical Site #58

Madrid, Spain

Exelixis Clinical Site #77

Madrid, Spain

Exelixis Clinical Site #19

Madrid, Spain

Exelixis Clinical Site #100

Madrid, Spain

Exelixis Clinical Site #18

Pamplona, Spain

Exelixis Clinical Site #119

Santander, Spain

Exelixis Clinical Site #23

Seville, Spain

Exelixis Clinical Site #56

Valencia, Spain

Exelixis Clinical Site #25

Valencia, Spain

Exelixis Clinical Site #21

Chur, Switzerland

Exelixis Clinical Site #22

Sankt Gallen, Switzerland

Exelixis Clinical Site #44

Winterthur, Switzerland

Exelixis Clinical Site #110

Cambridge, United Kingdom

Exelixis Clinical Site #99

London, United Kingdom

Exelixis Clinical Site #97

Middlesex, United Kingdom

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NCT05176483


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