Phase
Condition
Urothelial Cancer
Cervical Cancer
Pancreatic Cancer
Treatment
Nivolumab
Bevacizumab
XB002
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Exelixis Clinical Site#75
Miranda, New South Wales 2228
AustraliaSite Not Available
Exelixis Clinical Site#70
Nedlands, Western Australia 6009
AustraliaSite Not Available
Exelixis Clinical Site #37
Darlinghurst, 2010
AustraliaSite Not Available
Exelixis Clinical Site #44
Liverpool, 2170
AustraliaSite Not Available
Exelixis Clinical Site #35
Saint Leonards, 2065
AustraliaSite Not Available
Exelixis Clinical Site#71
Charleroi, Hainaut 6000
BelgiumSite Not Available
Exelixis Clinical Site#66
Liège, Liege 4000
BelgiumSite Not Available
Exelixis Clinical Site #30
Brussels, 1200
BelgiumSite Not Available
Exelixis Clinical Site#56
Brussels, 1070
BelgiumSite Not Available
Exelixis Clinical Site #47
Edegem, 2650
BelgiumSite Not Available
Exelixis Clinical Site #38
Gent, 9000
BelgiumSite Not Available
Exelixis Clinical Site#87
Paris, Ile-de-France 75013
FranceSite Not Available
Exelixis Clinical Site#69
Lyon, Rhone-Alpes 69373
FranceSite Not Available
Exelixis Clinical Site #45
Bordeaux, 33000
FranceSite Not Available
Exelixis Clinical Site #41
Pierre Benite, 69310
FranceSite Not Available
Exelixis Clinical Site#68
Poitiers, 86000
FranceSite Not Available
Exelixis Clinical Site #50
Rennes, 35042
FranceSite Not Available
Exelixis Clinical Site#63
Strasbourg, 67200
FranceSite Not Available
Exelixis Clinical Site#53
Villejuif, 94805
FranceSite Not Available
Exelixis Clinical Site#62
Milano, MI 20141
ItalySite Not Available
Exelixis Clinical Site #54
Ancona, 60126
ItalySite Not Available
Exelixis Clinical Site#60
Firenze, 50134
ItalySite Not Available
Exelixis Clinical Site#84
Milan, 20132
ItalySite Not Available
Exelixis Clinical Site #40
Roma, 00144
ItalySite Not Available
Exelixis Clinical Site#90
Roma, 00168
ItalySite Not Available
Exelixis Clinical Site #34
Rozzano, 20089
ItalySite Not Available
Exelixis Clinical Site#60
Siena, 53100
ItalyActive - Recruiting
Exelixis Clinical Site#61
Siena, 53100
ItalySite Not Available
Exelixis Clinical Site#80
Seongnam-si, Gyeonggi-Do 13496
Korea, Republic ofSite Not Available
Exelixis Clinical Site#79
Anyang-si, Gyeonggi-do 14068
Korea, Republic ofSite Not Available
Exelixis Clinical Site#74
Seongnam-si, Gyeonggido 13620
Korea, Republic ofSite Not Available
Exelixis Clinical Site#83
Suwon, Gyeonggido 16247
Korea, Republic ofSite Not Available
Exelixis Clinical Site#86
Busan, Gyeongsangnam-do 49201
Korea, Republic ofSite Not Available
Exelixis Clinical Site#78
Hwasun, Jeonranamdo 58128
Korea, Republic ofSite Not Available
Exelixis Clinical Site#77
Seoul, Seoul Teugbyeolsi 02841
Korea, Republic ofSite Not Available
Exelixis Clinical Site#81
Seoul, Seoul Teugbyeolsi 06351
Korea, Republic ofSite Not Available
Exelixis Clinical Site#85
Seoul, Seoul Teugbyeolsi 6591
Korea, Republic ofSite Not Available
Exelixis Clinical Site#94
Seoul, Seoul Teugbyeolsi 05505
Korea, Republic ofSite Not Available
Exelixis Clinical Site#73
Amsterdam, Noord-Holland 1066 CX
NetherlandsSite Not Available
Exelixis Clinical Site#76
Rotterdam, Zuid-Holland 3015 GD
NetherlandsSite Not Available
Exelixis Clinical Site#65
Groningen, 9713 GZ
NetherlandsSite Not Available
Exelixis Clinical Site #39
Maastricht, 6229 HX
NetherlandsSite Not Available
Exelixis Clinical Site #27
Barcelona, 08023
SpainSite Not Available
Exelixis Clinical Site #36
Barcelona, 08028
SpainSite Not Available
Exelixis Clinical Site#55
Barcelona, 8035
SpainSite Not Available
Exelixis Clinical Site#82
Barcelona, 8908
SpainSite Not Available
Exelixis Clinical Site #31
Lleida, 25198
SpainSite Not Available
Exelixis Clinical Site #13
Madrid, 28223
SpainSite Not Available
Exelixis Clinical Site #17
Madrid, 28027
SpainSite Not Available
Exelixis Clinical Site #33
Madrid, 28040
SpainSite Not Available
Exelixis Clinical Site #42
Madrid, 28050
SpainSite Not Available
Exelixis Clinical Site#64
Madrid, 1217
SpainSite Not Available
Exelixis Clinical Site #46
Málaga, 29010
SpainSite Not Available
Exelixis Clinical Site #43
Valencia, 46010
SpainSite Not Available
Exelixis Clinical Site #51
Valencia, 46026
SpainSite Not Available
Exelixis Clinical Site#72
Zaragoza, 50009
SpainSite Not Available
Exelixis Clinical Site#88
Leicester, England LE1 5WW
United KingdomSite Not Available
Exelixis Clinical Site#89
London, England SE1 9RT
United KingdomSite Not Available
Exelixis Clinical Site#91
Cardiff, Wales CF14 2TL
United KingdomSite Not Available
Exelixis Clinical Site #52
Glasgow, G12 0YN
United KingdomSite Not Available
Exelixis Clinical Site#57
London, W1T 7HA
United KingdomSite Not Available
Exelixis Clinical Site #28
Newcastle Upon Tyne, NE7 7DN
United KingdomSite Not Available
Exelixis Clinical Site #48
Birmingham, Alabama 35294
United StatesSite Not Available
Exelixis Clinical Site #20
Tucson, Arizona 85704
United StatesSite Not Available
Exelixis Clinical Site#95
Tucson, Arizona 85719
United StatesSite Not Available
Exelixis Clinical Site#58
Little Rock, Arkansas 72205
United StatesSite Not Available
Exelixis Clinical Site#59
Fountain Valley, California 92708
United StatesSite Not Available
Exelixis Clinical Site #21
Los Angeles, California 90025
United StatesSite Not Available
Exelixis Clinical Site #26
Los Angeles, California 90404
United StatesSite Not Available
Exelixis Clinical Site #16
New Haven, Connecticut 06511
United StatesSite Not Available
Exelixis Clinical Site #22
Washington, District of Columbia 20007
United StatesSite Not Available
Exelixis Clinical Site#93
Chicago, Illinois 60637
United StatesSite Not Available
Exelixis Clinical Site #6
Baltimore, Maryland 21287
United StatesSite Not Available
Exelixis Clinical Site #18
Columbia, Maryland 21044
United StatesSite Not Available
Exelixis Clinical Site #25
Boston, Massachusetts 02215
United StatesSite Not Available
Exelixis Clinical Site #10
Detroit, Michigan 49201
United StatesSite Not Available
Exelixis Clinical Site #19
Detroit, Michigan 48202
United StatesSite Not Available
Exelixis Clinical Site #5
Saint Louis, Missouri 63110
United StatesSite Not Available
Site 5
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Exelixis Clinical Site #11
Omaha, Nebraska 68130
United StatesSite Not Available
Exelixis Clinical Site #8
East Brunswick, New Jersey 08816
United StatesSite Not Available
Exelixis Clinical Site #7
New Brunswick, New Jersey 08903
United StatesSite Not Available
Exelixis Clinical Site #23
Albany, New York 12206
United StatesSite Not Available
Exelixis Clinical Site#67
Lake Success, New York 11042
United StatesSite Not Available
Exelixis Clinical Site #12
New York, New York 10016
United StatesSite Not Available
Exelixis Clinical Site #15
Cleveland, Ohio 44106
United StatesSite Not Available
Exelixis Clinical Site #29
Cleveland, Ohio 44195
United StatesSite Not Available
Exelixis Clinical Site #49
Hilliard, Ohio 43026
United StatesSite Not Available
Exelixis Clinical Site #4
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Site 4
Oklahoma City, Oklahoma 73104
United StatesActive - Recruiting
Exelixis Clinical Site #3
Nashville, Tennessee 37203
United StatesSite Not Available
Site 3
Nashville, Tennessee 37203
United StatesActive - Recruiting
Exelixis Clinical Site #1
Austin, Texas 78758
United StatesSite Not Available
Exelixis Clinical Site #24
Austin, Texas 78705
United StatesSite Not Available
Site 1
Austin, Texas 78758
United StatesActive - Recruiting
Exelixis Clinical Site #14
Dallas, Texas 75390
United StatesSite Not Available
Exelixis Clinical Site #32
Dallas, Texas 75246
United StatesSite Not Available
Exelixis Clinical Site#92
Houston, Texas 77030
United StatesSite Not Available
Exelixis Clinical Site #2
San Antonio, Texas 78229
United StatesSite Not Available
Site 2
San Antonio, Texas 78229
United StatesActive - Recruiting
Exelixis Clinical Site #9
Charlottesville, Virginia 22903
United StatesSite Not Available
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