Study of XB002 in Subjects With Solid Tumors (JEWEL-101)

Last updated: April 2, 2025
Sponsor: Exelixis
Overall Status: Completed

Phase

1

Condition

Urothelial Cancer

Cervical Cancer

Pancreatic Cancer

Treatment

Nivolumab

Bevacizumab

XB002

Clinical Study ID

NCT04925284
XB002-101
  • Ages > 18
  • All Genders

Study Summary

This is a Phase 1, open-label, multicenter, dose-escalation and expansion study evaluating the safety, tolerability, PK, pharmacodynamics, and clinical antitumor activity of XB002 administered IV q3w alone and in combination with nivolumab or bevacizumab to subjects with advanced solid tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Cytologically or histologically and radiologically confirmed solid tumor that isinoperable, locally advanced, metastatic, or recurrent.

  • Dose-Escalation Stage Cohorts A, AB, and AN: The subject has received at least onesystemic standard life-prolonging therapy unless it does not exist, or availabletherapies are intolerable or no longer effective.

  • Cohort-Expansion Stage (Cohorts B - M, BN, FN and HN): The subject has receivedstandard life-prolonging therapies unless they do not exist, or available therapiesare intolerable or no longer effective.

  • Cohort-Expansion Stage Cohort B and BN (Non-small Cell Lung Cancer): Subjects withStage IV NSCLC who have documented radiographic disease progression during orfollowing their last systemic anticancer therapy.

  • Cohort-Expansion Stage Cohort D (Epithelial Ovarian Cancer): Subjects withhigh-grade serous ovarian cancer, including primary peritoneal cancer (PPC) andfallopian tube cancer (FTC) who have platinum-resistant disease following treatmentwith platinum-containing chemotherapy.

  • Cohort-Expansion Stage Cohort E (Cervical Cancer): Subjects with persistent,recurrent, or metastatic carcinoma of the uterine cervix who have documentedradiographic disease progression during or following their last systemic anticancertherapy.

  • Cohorts F and FN (SCCHN): Subjects with head and neck cancer (squamous cellhistology) who have documented radiographic disease progression during or followingtheir last systemic anticancer therapy. Allowed primary tumor locations are oralcavity, oropharynx, hypopharynx, glottic larynx. Note: Excluded are subjects withprimary tumor site of the nasopharynx.

  • Cohort G (Pancreatic Cancer): Subjects with pancreatic cancer (adenocarcinomahistology) who have documented radiographic disease progression during or followingtheir last systemic anticancer therapy.

  • Cohort H (Esophageal SCC): Subjects with esophageal cancer (squamous cell histology)who have documented radiographic disease progression during or following their lastsystemic anticancer therapy. Note: subjects with esophageal adenocarcinoma andadenocarcinoma of gastroesophageal junction (GEJ) are excluded.

  • Cohort I (mCRPC): Subjects with metastatic, castration resistant adenocarcinoma ofthe prostate. Note: Neuroendocrine differentiation and other histological featuresare permitted if adenocarcinoma is the primary histology.

  • Cohort J (TNBC): Subjects with triple-negative (estrogen receptor negative [ER-]/progesterone receptor negative [PR-]/ human epidermal growth factor receptor 2negative [HER-2-]) breast cancer who have documented radiographic diseaseprogression during or following their last systemic anticancer therapy forinoperable locally advanced or metastatic disease.

  • Cohort K (HR + BC): Subjects with breast cancer that is hormone receptor-positive (ER+ and/or PR+) and HER-2-) and who have documented radiographic diseaseprogression during or following their last systemic anticancer therapy forinoperable locally advanced or metastatic disease.

  • Cohort L (Endometrial Cancer): Subjects with locally advanced, recurrent ormetastatic endometrial cancer who have documented radiographic disease progressionduring or following their last systemic anticancer therapy.

  • Cohort M (Tumor-Agnostic Tissue Factor-Expressing Solid Tumors): Subjects with solidtumors other than those designated in Cohorts B-L and those which express tissuefactor. Participation in this cohort will be at selected sites and countries basedon site feasibility assessment.

  • Expansion Cohorts: Subjects must have measurable disease per RECIST 1.1 asdetermined by the Investigator, except for subjects with prostate cancer withoutsoft tissue disease and subjects with primary brain tumors.

  • Tumor tissue material collected no more than 3 years prior to consent, if possible.If archival tumor tissue is not available, a fresh tumor biopsy may be collectedfrom subjects enrolled in the Dose-Escalation Stage and should be collected fromsubjects in the Cohort-Expansion Stage.

  • Recovery to baseline or ≤ Grade 1 severity (Common Terminology Criteria for AdverseEvents version 5 [CTCAE v5]) from AEs.

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.

  • Adequate organ and marrow function.

  • Sexually active fertile subjects and their partners must agree to use medicallyaccepted methods of contraception.

  • Female subjects of childbearing potential must not be pregnant at screening.

Exclusion

Exclusion Criteria:

  • Receipt of prior therapies as defined in study protocol

  • Known brain metastases or cranial epidural disease unless adequately treated withradiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeksbefore first dose of study treatment.

  • Uncontrolled, significant intercurrent or recent illness.

  • Major surgery within 4 weeks before first dose of study treatment

  • Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms perelectrocardiogram (ECG).

  • Pregnant or lactating females

  • Previously identified allergy or hypersensitivity to components of study treatmentformulations or history of severe infusion-related reactions to monoclonalantibodies.

  • Another unresolved malignancy or a malignancy that is considered to be cured within 2 years before first dose of study treatment. Note: Subjects with superficialnon-melanoma skin cancers, or localized, low grade tumors deemed cured and nottreated with systemic therapy within 2 years before first dose of study treatmentare eligible.

Study Design

Total Participants: 269
Treatment Group(s): 3
Primary Treatment: Nivolumab
Phase: 1
Study Start date:
June 07, 2021
Estimated Completion Date:
March 10, 2025

Connect with a study center

  • Exelixis Clinical Site#75

    Miranda, New South Wales 2228
    Australia

    Site Not Available

  • Exelixis Clinical Site#70

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Exelixis Clinical Site #37

    Darlinghurst, 2010
    Australia

    Site Not Available

  • Exelixis Clinical Site #44

    Liverpool, 2170
    Australia

    Site Not Available

  • Exelixis Clinical Site #35

    Saint Leonards, 2065
    Australia

    Site Not Available

  • Exelixis Clinical Site#71

    Charleroi, Hainaut 6000
    Belgium

    Site Not Available

  • Exelixis Clinical Site#66

    Liège, Liege 4000
    Belgium

    Site Not Available

  • Exelixis Clinical Site #30

    Brussels, 1200
    Belgium

    Site Not Available

  • Exelixis Clinical Site#56

    Brussels, 1070
    Belgium

    Site Not Available

  • Exelixis Clinical Site #47

    Edegem, 2650
    Belgium

    Site Not Available

  • Exelixis Clinical Site #38

    Gent, 9000
    Belgium

    Site Not Available

  • Exelixis Clinical Site#87

    Paris, Ile-de-France 75013
    France

    Site Not Available

  • Exelixis Clinical Site#69

    Lyon, Rhone-Alpes 69373
    France

    Site Not Available

  • Exelixis Clinical Site #45

    Bordeaux, 33000
    France

    Site Not Available

  • Exelixis Clinical Site #41

    Pierre Benite, 69310
    France

    Site Not Available

  • Exelixis Clinical Site#68

    Poitiers, 86000
    France

    Site Not Available

  • Exelixis Clinical Site #50

    Rennes, 35042
    France

    Site Not Available

  • Exelixis Clinical Site#63

    Strasbourg, 67200
    France

    Site Not Available

  • Exelixis Clinical Site#53

    Villejuif, 94805
    France

    Site Not Available

  • Exelixis Clinical Site#62

    Milano, MI 20141
    Italy

    Site Not Available

  • Exelixis Clinical Site #54

    Ancona, 60126
    Italy

    Site Not Available

  • Exelixis Clinical Site#60

    Firenze, 50134
    Italy

    Site Not Available

  • Exelixis Clinical Site#84

    Milan, 20132
    Italy

    Site Not Available

  • Exelixis Clinical Site #40

    Roma, 00144
    Italy

    Site Not Available

  • Exelixis Clinical Site#90

    Roma, 00168
    Italy

    Site Not Available

  • Exelixis Clinical Site #34

    Rozzano, 20089
    Italy

    Site Not Available

  • Exelixis Clinical Site#60

    Siena, 53100
    Italy

    Active - Recruiting

  • Exelixis Clinical Site#61

    Siena, 53100
    Italy

    Site Not Available

  • Exelixis Clinical Site#80

    Seongnam-si, Gyeonggi-Do 13496
    Korea, Republic of

    Site Not Available

  • Exelixis Clinical Site#79

    Anyang-si, Gyeonggi-do 14068
    Korea, Republic of

    Site Not Available

  • Exelixis Clinical Site#74

    Seongnam-si, Gyeonggido 13620
    Korea, Republic of

    Site Not Available

  • Exelixis Clinical Site#83

    Suwon, Gyeonggido 16247
    Korea, Republic of

    Site Not Available

  • Exelixis Clinical Site#86

    Busan, Gyeongsangnam-do 49201
    Korea, Republic of

    Site Not Available

  • Exelixis Clinical Site#78

    Hwasun, Jeonranamdo 58128
    Korea, Republic of

    Site Not Available

  • Exelixis Clinical Site#77

    Seoul, Seoul Teugbyeolsi 02841
    Korea, Republic of

    Site Not Available

  • Exelixis Clinical Site#81

    Seoul, Seoul Teugbyeolsi 06351
    Korea, Republic of

    Site Not Available

  • Exelixis Clinical Site#85

    Seoul, Seoul Teugbyeolsi 6591
    Korea, Republic of

    Site Not Available

  • Exelixis Clinical Site#94

    Seoul, Seoul Teugbyeolsi 05505
    Korea, Republic of

    Site Not Available

  • Exelixis Clinical Site#73

    Amsterdam, Noord-Holland 1066 CX
    Netherlands

    Site Not Available

  • Exelixis Clinical Site#76

    Rotterdam, Zuid-Holland 3015 GD
    Netherlands

    Site Not Available

  • Exelixis Clinical Site#65

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

  • Exelixis Clinical Site #39

    Maastricht, 6229 HX
    Netherlands

    Site Not Available

  • Exelixis Clinical Site #27

    Barcelona, 08023
    Spain

    Site Not Available

  • Exelixis Clinical Site #36

    Barcelona, 08028
    Spain

    Site Not Available

  • Exelixis Clinical Site#55

    Barcelona, 8035
    Spain

    Site Not Available

  • Exelixis Clinical Site#82

    Barcelona, 8908
    Spain

    Site Not Available

  • Exelixis Clinical Site #31

    Lleida, 25198
    Spain

    Site Not Available

  • Exelixis Clinical Site #13

    Madrid, 28223
    Spain

    Site Not Available

  • Exelixis Clinical Site #17

    Madrid, 28027
    Spain

    Site Not Available

  • Exelixis Clinical Site #33

    Madrid, 28040
    Spain

    Site Not Available

  • Exelixis Clinical Site #42

    Madrid, 28050
    Spain

    Site Not Available

  • Exelixis Clinical Site#64

    Madrid, 1217
    Spain

    Site Not Available

  • Exelixis Clinical Site #46

    Málaga, 29010
    Spain

    Site Not Available

  • Exelixis Clinical Site #43

    Valencia, 46010
    Spain

    Site Not Available

  • Exelixis Clinical Site #51

    Valencia, 46026
    Spain

    Site Not Available

  • Exelixis Clinical Site#72

    Zaragoza, 50009
    Spain

    Site Not Available

  • Exelixis Clinical Site#88

    Leicester, England LE1 5WW
    United Kingdom

    Site Not Available

  • Exelixis Clinical Site#89

    London, England SE1 9RT
    United Kingdom

    Site Not Available

  • Exelixis Clinical Site#91

    Cardiff, Wales CF14 2TL
    United Kingdom

    Site Not Available

  • Exelixis Clinical Site #52

    Glasgow, G12 0YN
    United Kingdom

    Site Not Available

  • Exelixis Clinical Site#57

    London, W1T 7HA
    United Kingdom

    Site Not Available

  • Exelixis Clinical Site #28

    Newcastle Upon Tyne, NE7 7DN
    United Kingdom

    Site Not Available

  • Exelixis Clinical Site #48

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Exelixis Clinical Site #20

    Tucson, Arizona 85704
    United States

    Site Not Available

  • Exelixis Clinical Site#95

    Tucson, Arizona 85719
    United States

    Site Not Available

  • Exelixis Clinical Site#58

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Exelixis Clinical Site#59

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Exelixis Clinical Site #21

    Los Angeles, California 90025
    United States

    Site Not Available

  • Exelixis Clinical Site #26

    Los Angeles, California 90404
    United States

    Site Not Available

  • Exelixis Clinical Site #16

    New Haven, Connecticut 06511
    United States

    Site Not Available

  • Exelixis Clinical Site #22

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Exelixis Clinical Site#93

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Exelixis Clinical Site #6

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Exelixis Clinical Site #18

    Columbia, Maryland 21044
    United States

    Site Not Available

  • Exelixis Clinical Site #25

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Exelixis Clinical Site #10

    Detroit, Michigan 49201
    United States

    Site Not Available

  • Exelixis Clinical Site #19

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Exelixis Clinical Site #5

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Site 5

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Exelixis Clinical Site #11

    Omaha, Nebraska 68130
    United States

    Site Not Available

  • Exelixis Clinical Site #8

    East Brunswick, New Jersey 08816
    United States

    Site Not Available

  • Exelixis Clinical Site #7

    New Brunswick, New Jersey 08903
    United States

    Site Not Available

  • Exelixis Clinical Site #23

    Albany, New York 12206
    United States

    Site Not Available

  • Exelixis Clinical Site#67

    Lake Success, New York 11042
    United States

    Site Not Available

  • Exelixis Clinical Site #12

    New York, New York 10016
    United States

    Site Not Available

  • Exelixis Clinical Site #15

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Exelixis Clinical Site #29

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Exelixis Clinical Site #49

    Hilliard, Ohio 43026
    United States

    Site Not Available

  • Exelixis Clinical Site #4

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Site 4

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • Exelixis Clinical Site #3

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Site 3

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Exelixis Clinical Site #1

    Austin, Texas 78758
    United States

    Site Not Available

  • Exelixis Clinical Site #24

    Austin, Texas 78705
    United States

    Site Not Available

  • Site 1

    Austin, Texas 78758
    United States

    Active - Recruiting

  • Exelixis Clinical Site #14

    Dallas, Texas 75390
    United States

    Site Not Available

  • Exelixis Clinical Site #32

    Dallas, Texas 75246
    United States

    Site Not Available

  • Exelixis Clinical Site#92

    Houston, Texas 77030
    United States

    Site Not Available

  • Exelixis Clinical Site #2

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Site 2

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Exelixis Clinical Site #9

    Charlottesville, Virginia 22903
    United States

    Site Not Available

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