Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid Tumors (STELLAR-002)

May 22, 2026 updated by: Exelixis

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1314

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Exelixis Clinical Trials
  • Phone Number: 1-888-EXELIXIS (888-393-5494)
  • Email: druginfo@exelixis.com

Study Contact Backup

  • Name: Backup or International
  • Phone Number: 650-837-7400

Study Locations

  • Australia
      • Albury, Australia, 2640
        • Recruiting
        • Exelixis Clinical Site #116
      • Birtinya, Australia, 4575
        • Recruiting
        • Exelixis Clinical Site #35
      • Brisbane, Australia, 4102
        • Recruiting
        • Exelixis Clinical Site #16
      • Saint Leonards, Australia, 2065
        • Recruiting
        • Exelixis Clinical Site #42
      • Sydney, Australia, 2109
        • Recruiting
        • Exelixis Clinical Site #36
  • Austria
      • Graz, Austria, 8036
        • Recruiting
        • Exelixis Clinical Site #94
      • Salzburg, Austria, 5020
        • Completed
        • Exelixis Clinical Site #31
      • Vienna, Austria, 1020
        • Recruiting
        • Exelixis Clinical Site #29
      • Wein, Austria, 1090
        • Recruiting
        • Exelixis Clinical Site #106
  • Belgium
      • Anderlecht, Belgium, 1070
        • Completed
        • Exelixis Clinical Site #39
      • Kortrijk, Belgium, 8500
        • Recruiting
        • Exelixis Clinical Site #37
  • France
      • Besançon, France, 25030
        • Recruiting
        • Exelixis Clinical Site #85
      • Bordeaux, France, 33000
        • Recruiting
        • Exelixis Clinical Site #96
      • Caen, France, 14076
        • Recruiting
        • Exelixis Clinical Site #79
      • Clermont-Ferrand, France, 63011
        • Recruiting
        • Exelixis Clinical Site #118
      • Lyon, France, 69008
        • Withdrawn
        • Exelixis Clinical Site #109
      • Marseille, France, 13273
        • Recruiting
        • Exelixis Clinical Site #92
      • Nice, France, 06189
        • Recruiting
        • Exelixis Clinical Site #64
      • Paris, France, 75010
        • Recruiting
        • Exelixis Clinical Site #83
      • Paris, France, 75015
        • Withdrawn
        • Exelixis Clinical Site #91
      • Rennes, France, 35042
        • Recruiting
        • Exelixis Clinical Site #80
      • Saint-Herblain, France, 44805
        • Recruiting
        • Exelixis Clinical Site #63
      • Strasbourg, France, 67200
        • Recruiting
        • Exelixis Clinical Site #75
      • Vandœuvre-lès-Nancy, France, 54519
        • Recruiting
        • Exelixis Clinical Site #84
      • Villejuif, France, 94805
        • Recruiting
        • Exelixis Clinical Site #115
  • Germany
      • Essen, Germany, 45147
        • Recruiting
        • Exelixis Clinical Site #103
      • Hamburg, Germany, 22763
        • Recruiting
        • Exelixis Clinical Site #113
      • Heidelberg, Germany, 69120
        • Recruiting
        • Exelixis Clinical Site #108
      • Herne, Germany, 44625
        • Recruiting
        • Exelixis Clinical Site #82
      • Jena, Germany, 07747
        • Recruiting
        • Exelixis Clinical Site #93
      • München, Germany, 81737
        • Completed
        • Exelixis Clinical Site #112
      • Nürtingen, Germany, 72622
        • Recruiting
        • Exelixis Clinical Site #102
      • Trier, Germany, 54292
        • Recruiting
        • Exelixis Clinical Site #107
      • Tübingen, Germany, 72076
        • Recruiting
        • Exelixis Clinical Site #95
  • Israel
      • Beersheba, Israel, 8410101
        • Recruiting
        • Exelixis Clinical Site #86
      • Haifa, Israel, 3109601
        • Recruiting
        • Exelixis Clinical Site #72
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Exelixis Clinical Site #52
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Exelixis Clinical Site #71
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Exelixis Clinical Site #69
      • Ẕerifin, Israel, 7030000
        • Recruiting
        • Exelixis Clinical Site #38
  • Italy
      • Ancona, Italy, 60020
        • Recruiting
        • Exelixis Clinical Site #121
      • Bologna, Italy, 40138
        • Recruiting
        • Exelixis Clinical Site #117
      • Florence, Italy, 50134
        • Recruiting
        • Exelixis Clinical Site #90
      • Milan, Italy, 20132
        • Recruiting
        • Exelixis Clinical Site #101
      • Milan, Italy, 20141
        • Recruiting
        • Exelixis Clinical Site #81
      • Naples, Italy, 80131
        • Recruiting
        • Exelixis Clinical Site #40
      • Ravenna, Italy, 48121
        • Recruiting
        • Exelixis Clinical Site #74
  • New Zealand
      • Grafton, New Zealand, 1023
        • Recruiting
        • Exelixis Clinical Site #30
      • Hamilton, New Zealand, 3204
        • Recruiting
        • Exelixis Clinical Site #45
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Recruiting
        • Exelixis Clinical Site #20
      • Gdansk, Poland, 80-219
        • Recruiting
        • Exelixis Clinical Site #28
      • Otwock, Poland, 05-400
        • Recruiting
        • Exelixis Clinical Site #34
      • Poznan, Poland, 60-569
        • Recruiting
        • Exelixis Clinical Site #54
      • Wroclaw, Poland, 53-413
        • Recruiting
        • Exelixis Clinical Site #114
  • Spain
      • Badajoz, Spain, 06080
        • Recruiting
        • Exelixis Clinical Site #41
      • Barcelona, Spain, 08041
        • Recruiting
        • Exelixis Clinical Site #27
      • Barcelona, Spain, 08035
        • Recruiting
        • Exelixis Clinical Site #53
      • Barcelona, Spain, 08036
        • Recruiting
        • Exelixis Clinical Site #15
      • L'Hospitalet de Llobregat, Spain, 08908
        • Recruiting
        • Exelixis Clinical Site #120
      • Madrid, Spain, 28041
        • Recruiting
        • Exelixis Clinical Site #19
      • Madrid, Spain, 28034
        • Recruiting
        • Exelixis Clinical Site #43
      • Madrid, Spain, 28033
        • Recruiting
        • Exelixis Clinical Site #57
      • Madrid, Spain, 28040
        • Recruiting
        • Exelixis Clinical Site #58
      • Madrid, Spain, 28040
        • Recruiting
        • Exelixis Clinical Site #77
      • Madrid, Spain, 28046
        • Recruiting
        • Exelixis Clinical Site #100
      • Pamplona, Spain, 31008
        • Recruiting
        • Exelixis Clinical Site #18
      • Santander, Spain, 39008
        • Recruiting
        • Exelixis Clinical Site #119
      • Seville, Spain, 41013
        • Recruiting
        • Exelixis Clinical Site #23
      • Valencia, Spain, 46026
        • Recruiting
        • Exelixis Clinical Site #25
      • Valencia, Spain, 46010
        • Recruiting
        • Exelixis Clinical Site #56
  • Switzerland
      • Chur, Switzerland, 7000
        • Completed
        • Exelixis Clinical Site #21
      • Sankt Gallen, Switzerland, 9007
        • Recruiting
        • Exelixis Clinical Site #22
      • Winterthur, Switzerland, 8401
        • Recruiting
        • Exelixis Clinical Site #44
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Recruiting
        • Exelixis Clinical Site #110
      • London, United Kingdom, W6 8RF
        • Recruiting
        • Exelixis Clinical Site #99
      • Middlesex, United Kingdom, HA6 2RN
        • Recruiting
        • Exelixis Clinical Site #97
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Exelixis Clinical Site #67
      • Tucson, Arizona, United States, 85711
        • Recruiting
        • Exelixis Clinical Site #1
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Exelixis Clinical Site #123
      • Santa Barbara, California, United States, 93463
        • Recruiting
        • Exelixis Clinical Site #59
    • Colorado
      • Littleton, Colorado, United States, 80124
        • Recruiting
        • Exelixis Clinical Site #87
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Exelixis Clinical Site #62
    • Delaware
      • Newark, Delaware, United States, 19713
        • Active, not recruiting
        • Exelixis Clinical Site #49
    • Florida
      • Celebration, Florida, United States, 34747
        • Recruiting
        • Exelixis Clinical Site #48
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • Exelixis Clinical Site #11
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Exelixis Clinical Site #78
      • Miami, Florida, United States, 33136
        • Recruiting
        • Exelixis Clinical Site #47
      • Plantation, Florida, United States, 33322
        • Recruiting
        • Exelixis Clinical Site #61
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Exelixis Clinical Site #8
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Exelixis Clinical Site #26
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Recruiting
        • Exelixis Clinical Site #4
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Exelixis Clinical Site #122
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • Exelixis Clinical Site #14
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Exelixis Clinical Site #7
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Exelixis Clinical Site #13
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Exelixis Clinical Site #65
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Exelixis Clinical Site #68
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • Exelixis Clinical Site #2
      • Omaha, Nebraska, United States, 68130
        • Active, not recruiting
        • Exelixis Clinical Site #5
    • Nevada
      • Las Vegas, Nevada, United States, 89052
        • Recruiting
        • Exelixis Clinical Site #55
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Recruiting
        • Exelixis Clinical Site #88
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Exelixis Clinical Site #105
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Exelixis Clinical Site #6
      • New York, New York, United States, 10032
        • Recruiting
        • Exelixis Clinical Site #60
      • Syracuse, New York, United States, 13210
        • Recruiting
        • Exelixis Clinical Site #76
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Exelixis Clinical Site #12
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Exelixis Clinical Site #10
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Exelixis Clinical Site #51
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Exelixis Clinical Site #104
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Exelixis Clinical Site #98
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • Exelixis Clinical Site #24
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Exelixis Clinical Site #32
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Recruiting
        • Exelixis Clinical Site #9
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Exelixis Clinical Site #3
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Exelixis Clinical Site #46
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Exelixis Clinical Site #89
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Exelixis Clinical Site #111
      • Irving, Texas, United States, 75063
        • Recruiting
        • Exelixis Clinical Site #73
      • Plano, Texas, United States, 75075
        • Recruiting
        • Exelixis Clinical Site #50
      • Tyler, Texas, United States, 75601
        • Recruiting
        • Exelixis Clinical Site #70
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • Exelixis Clinical Site #66
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Exelixis Clinical Site #33

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Cytologically or histologically confirmed solid tumor that is unresectable, locally advanced or metastatic.
  • Dose-Escalation Cohorts: Participants with a solid tumor that is unresectable or metastatic and for which life-prolonging therapies do not exist or available therapies are intolerable or no longer effective.

  • Expansion Cohort 1 (ccRCC): Participants with unresectable advanced or metastatic RCC with a clear cell component who have not received prior systemic therapy.

    • Note: Prior non-vascular endothelial growth factor (VEGF) targeted adjuvant or neoadjuvant is allowed if disease recurrence occurred 6 months after the last dose.

  • Expansion Cohort 2 (ccRCC): Participants with unresectable advanced or metastatic RCC with a clear cell component.

    • Must have radiographically progressed after a combination therapy consisting of a Programmed Cell Death Protein 1 (PD-1)/Programmed death-ligand 1 (PD-L1) targeting monoclonal antibody (mAb) with a Vascular endothelial growth factor (receptor) tyrosine kinase inhibitor (VEGFR-TKI) or a PD-1 targeting mAb with a CTLA-4 mAb as the preceding line of therapy.
    • Must have received no more than one prior systemic anticancer therapy for unresectable advanced or metastatic renal cell carcinoma.

  • Expansion Cohort 3 (mCRPC): Men with metastatic adenocarcinoma of the prostate.

    • Must have progressed during or after one novel hormone therapy (NHT) given for castration-sensitive locally advanced (T3 or T4) or metastatic castration-sensitive prostate cancer (CSPC), M0 CRPC, or mCRPC.

  • Expansion Cohort 4 (UC, ICI-naive): Participants with histologically confirmed unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra).

    • Must have progressed during or after prior first-line platinum-based combination therapy, including participants who received prior neoadjuvant or adjuvant platinum-containing therapy with disease recurrence < 12 months from the end of last therapy.
    • Must have received no more than 1 prior line of systemic anticancer therapy for unresectable, locally advanced or metastatic disease.

  • Expansion Cohort 5 (post enfortumab vedotin [EV] and ICI): Participants with histologically confirmed unresectable, locally advanced or metastatic predominant urothelial carcinoma.

    • Progressive disease following prior EV or ineligible for EV, and progression following prior PD-1/PD-L1 inhibitor or ineligible for PD-1/PD-L1 inhibitor.
    • Prior receipt of platinum-based therapy allowed but not required.
    • Prior therapy with other agents allowed but not required.

  • Expansion Cohort 6 (nccRCC): Participants with unresectable advanced or metastatic nccRCC of the following subtypes: Papillary, unclassified RCC, and translocation-associated, Fumarate Hydratase (FH) deficient and Succinate Dehydrogenase (SDH) deficient. Among the eligible histologic subtypes, sarcomatoid features are allowed.

    • No prior systemic anticancer therapy is allowed except adjuvant or neoadjuvant therapy if disease recurrence occurred at least 6 months after the last dose.
  • Expansion Cohort 7 (HCC): Participants with locally advanced, or metastatic and/or unresectable HCC that is not amenable to curative treatment or locoregional therapy.
  • Expansion Cohort 8 (NSCLC): Participants with Stage IV non-squamous NSCLC with positive PD-L1 expression (tumor proportion score [TPS] 1-49%) and without prior systemic anticancer therapy for metastatic disease.
  • Expansion Cohort 9 (NSCLC): Participants with Stage IV non-squamous NSCLC who have radiologically progressed following treatment with one prior immune checkpoint inhibitor (anti-PD-1 or anti-PD-L1) for metastatic disease.
  • Expansion Cohort 10 (CRC): Participants with histologically confirmed unresectable, locally advanced, or metastatic adenocarcinoma of the colon or rectum.
  • Expansion Cohort 11 (HNSCC): Participant with inoperable, refractory, recurrent or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx. PD-L1 combined positive score (CPS) ≥1.

  • Expansion Cohort 12 (ccRCC): Participants with unresectable advance or metastatic RCC with a clear cell component, including participants who also have a sacromatoid feature.

    • Must have received no more than two prior lines of systemic anticancer therapy for unresectable advanced or metastatic renal cell carcinoma
  • Expansion Cohort 13 and Cohort 14 (ccRCC 1L): Participants with unresectable advanced or metastatic RCC with a clear component, including participants who also have a sacromatoid feature.
  • For all Expansion Cohorts except Cohort 3: Measurable disease per RECIST 1.1 as determined by the Investigator.
  • For Expansion Cohorts 1 - 11 Only: Archival tumor tissue material, if available, or fresh tumor tissue if it can be safely obtained.
  • Recovery to baseline or ≤ Grade 1 common terminology criteria for adverse events (CTCAE) v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Investigator and/or stable on supportive therapy.
  • Karnofsky Performance Status (KPS) ≥ 70%.
  • Adequate organ and marrow function.
  • Sexually active fertile participants and their partners must agree to use highly effective methods of contraception.
  • Females of childbearing potential must not be pregnant at screening.

Key Exclusion Criteria:

  • For all Dose-Escalation cohorts: Prior treatment with zanzalintinib. For all Expansion Cohorts: Prior treatment with zanzalintinib, nivolumab, ipilimumab or relatlimab with the following exceptions: Prior PD-1/PD-L1, Lymphocyte-activation gene 3 (LAG-3) and cCytotoxic T lymphocyte associated protein 4 (CTLA-4) targeting therapy for locally advanced or metastatic disease is allowed for Cohort 2 (ccRCC), Cohort 5 (UC), Cohort 9 (NSCLC), and Cohort 12 (ccRCC), and prior treatment in the neoadjuvant or adjuvant setting is allowed for Cohort 13 and Cohort 14 (ccRCC 1L).
  • For all Dose-Escalation Cohorts and Expansion Cohort 2 (ccRCC), 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC), Cohort 10 (CRC), and Cohort 12: Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.
  • For Cohort 3 (mCRPC): Receipt of abiraterone within 1 week; cyproterone within 10 days; or receipt of flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen receptor inhibitors within 2 weeks before first dose of study treatment.
  • For all Dose-Escalation Cohorts and Expansion Cohort 2 (ccRCC), Cohort 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC) and Cohort 10 (CRC), and Cohort 12: Receipt of any type of anticancer antibody or systemic chemotherapy within 4 weeks before first dose of study treatment.
  • Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.
  • Prior external radiation therapy for bone metastasis within 2 weeks, for other tumor sites within 4 weeks, and prior radium-223 therapy within 6 weeks before first dose of study treatment, unless otherwise specified.
  • Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment.
  • Concomitant anticoagulation with oral anticoagulants, except for specified direct factor Xa inhibitors.
  • Administration of a live, attenuated vaccine within 30 days prior to first dose.
  • Uncontrolled, significant intercurrent or recent illness.
  • Corrected QT interval calculated by the Fridericia formula (QTcF) > 460 ms for females and > 450 ms for males per electrocardiogram (ECG) within 14 days before first dose of study treatment.
  • Participants with inadequately treated adrenal insufficiency.
  • Pregnant or lactating females.
  • Any other active malignancy within two years before first dose of study treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy. Incidentally diagnosed prostate cancer is allowed if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6.
  • For Cohort 2 (ccRCC, 2L): Receipt of a prior triplet therapy including a VEGFR-TKI, a PD1 targeting mAb, and a CTLA-4 mAb.
  • For Cohort 3 (mCRPC): Receipt of a taxane-based chemotherapy for mCRPC.
  • For Cohort 4 (UC, ICI-naïve): Participants who have had recurrence within the 6 months of completing adjuvant anti-PD-(L)1 treatment.
  • For Cohort 6 (nccRCC, 1L): Participants with chromophobe, renal medullary carcinoma, or pure collecting duct nccRCC.

  • For Cohort 7 (HCC):

    • Documented hepatic encephalopathy (HE) within 6 months before the first dose.
    • Clinically meaningful ascites (ie, ascites requiring paracentesis or escalation in diuretics) within 6 months before randomization.
    • Participants who have received any local anticancer therapy including surgery, percutaneous ethanol injection (PEI), radiofrequency ablation (RFA), microwave ablation (MWA), transarterial chemoembolization (TACE), or transarterial radioembolization (TARE) within 28 days prior to first dose.
    • Participants with known fibrolamellar carcinoma, sarcomatoid HCC, or mixed hepatocellular cholangiocarcinoma
  • For Cohort 10 (CRC, 2L+): Receipt of prior therapy with regorafenib and/or trifluridine + tipiracil (TAS-102).
  • For Cohort 11 (HNSCC): Primary tumor site of the nasopharyngeal area.

  • For Cohorts 1 (ccRCC, 1L), 2 (ccRCC, 2L), 4, 5 (UC), 7 (HCC), 8 (NSCLC 1L PD-L1 low), 9 (NSCLC, 2L+), 10 (CRC, microsatellite stable [MSS], 2L+), and 11 (HNSCC):

    • Troponin T (TnT) or I (TnI) > 2 × institutional upper limit of normal (ULN).

Note: Additional Inclusion and Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zanzalintinib + Nivolumab Expansion Cohorts
The recommended dose from the dose-escalation stage may be further explored in tumor-specific cohorts.
Drug: Nivolumab
360 mg IV infusion once every 3 weeks (q3w)
Other Names:
  • Opdivo
Drug: Nivolumab
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)
Other Names:
  • Opdivo
Drug: Nivolumab
480 mg IV infusion once every 4 weeks (q4w)
Other Names:
  • Opdivo
Drug: Zanzalintinib
Zanzalintinib orally once daily (qd)
Other Names:
  • XL092
Experimental: Zanzalintinib + Nivolumab + Ipilimumab Expansion Cohorts
The recommended dose from the dose-escalation stage may be further explored in tumor-specific cohorts.
Drug: Nivolumab
360 mg IV infusion once every 3 weeks (q3w)
Other Names:
  • Opdivo
Drug: Nivolumab
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)
Other Names:
  • Opdivo
Drug: Nivolumab
480 mg IV infusion once every 4 weeks (q4w)
Other Names:
  • Opdivo
Drug: Ipilimumab
1 mg/kg IV infusion once every 3 weeks (q3w) for maximum of four doses
Other Names:
  • Yervoy
Drug: Zanzalintinib
Zanzalintinib orally once daily (qd)
Other Names:
  • XL092
Experimental: Zanzalintinib Single-Agent Expansion Cohorts
Drug: Zanzalintinib
Zanzalintinib orally once daily (qd)
Other Names:
  • XL092
Experimental: Zanzalintinib + Nivolumab + Relatlimab Expansion Cohorts
The recommended dose from the dose-escalation stage may be further explored in tumor-specific cohorts.
Drug: Nivolumab + Relatlimab
IV administration of nivolumab + relatlimab
Drug: Zanzalintinib
Zanzalintinib orally once daily (qd)
Other Names:
  • XL092
Experimental: Zanzalintinib + Nivolumab Dose-Escalation Cohorts
Approximately 12 participants will accrue across 1-2 dose levels of Zanzalintinib following the "rolling 6" design.
Drug: Nivolumab
360 mg IV infusion once every 3 weeks (q3w)
Other Names:
  • Opdivo
Drug: Nivolumab
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)
Other Names:
  • Opdivo
Drug: Nivolumab
480 mg IV infusion once every 4 weeks (q4w)
Other Names:
  • Opdivo
Drug: Zanzalintinib
Zanzalintinib orally once daily (qd)
Other Names:
  • XL092
Experimental: Zanzalintinib + Nivolumab + Ipilimumab Dose-Escalation Cohorts
Approximately 12 participants will accrue across 1-2 dose levels of Zanzalintinib following the "rolling 6" design.
Drug: Nivolumab
360 mg IV infusion once every 3 weeks (q3w)
Other Names:
  • Opdivo
Drug: Nivolumab
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)
Other Names:
  • Opdivo
Drug: Nivolumab
480 mg IV infusion once every 4 weeks (q4w)
Other Names:
  • Opdivo
Drug: Ipilimumab
1 mg/kg IV infusion once every 3 weeks (q3w) for maximum of four doses
Other Names:
  • Yervoy
Drug: Zanzalintinib
Zanzalintinib orally once daily (qd)
Other Names:
  • XL092
Experimental: Zanzalintinib + Nivolumab + Relatlimab Dose-Escalation Cohorts
Approximately 12 participants will accrue across 1-2 dose levels of Zanzalintinib following the "rolling 6" design.
Drug: Nivolumab + Relatlimab
IV administration of nivolumab + relatlimab
Drug: Zanzalintinib
Zanzalintinib orally once daily (qd)
Other Names:
  • XL092

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Including Immune-Mediated Adverse Events (imAEs)
Time Frame: Up to 36 months
Up to 36 months
Expansion Stage: Objective Response Rate (ORR)
Time Frame: Up to 24 months
To evaluate ORR in participants with measurable disease as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors guideline version 1.1 (RECIST 1.1).
Up to 24 months
Expansion Stage Cohort 3 (mCRPC): Progression-Free Survival (PFS)
Time Frame: Up to 24 months
To evaluate duration of radiographic PFS as determined per Prostate Working Group 3 (PCWG3) criteria by Blinded Independent Radiology Committee (BIRC).
Up to 24 months
Expansion Stage Cohort 10 (CRC): Overall Survival (OS)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expansion Stage: Duration of Response (DOR)
Time Frame: Up to 24 months
To evaluate DOR in participants with measurable disease as assessed by the Investigator per RECIST 1.1.
Up to 24 months
Expansion Stage: Progression-Free Survival (PFS)
Time Frame: Up to 24 months
To evaluate PFS in participants with measurable disease as assessed by the Investigator per RECIST 1.1.
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Exelixis

Investigators

  • Study Director: Medical Director, Exelixis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2021

Primary Completion (Estimated)

June 28, 2030

Study Completion (Estimated)

June 28, 2030

Study Registration Dates

First Submitted

December 15, 2021

First Submitted That Met QC Criteria

December 15, 2021

First Posted (Actual)

January 4, 2022

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XL092-002
  • 2023-510061-10-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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