Study of XB002 in Subjects With Solid Tumors (JEWEL-101)
NCT ID: NCT04925284
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
269 participants
INTERVENTIONAL
2021-06-07
2025-03-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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XB002 Single-Agent Dose-Escalation Cohorts
Subjects (Cohort A) will accrue in cohorts of 3-12 subjects in a modified i3+3 design.
XB002
IV administration of XB002
XB002 Single-Agent Expansion Cohorts
The MTD or recommended dose from the dose-escalation stage may be further explored in subjects with non-small cell lung cancer \[NSCLC\] (Cohort B), epithelial ovarian cancer (Cohort D), cervical cancer (Cohort E), SCCHN (Cohort F), pancreatic cancer (Cohort G), Esophageal SCC (Cohort H), metastatic castration-resistant prostate cancer (Cohort I), triple-negative breast cancer (Cohort J), hormone-receptor positive breast cancer (Cohort K), endometrial cancer (Cohort L) and tumor agnostic tissue factor-expressing solid tumors (Cohort M).
XB002
IV administration of XB002
XB002 + Nivolumab Dose Escalation Cohorts
Subjects (Cohort AN) will accrue in cohorts of 3-12 subjects in a modified i3+3 design.
XB002
IV administration of XB002
Nivolumab
IV administration of Nivolumab
XB002 + Nivolumab Dose Expansion Cohorts
The MTD or recommended dose from the dose-escalation stage may be further explored in subjects with non-small cell lung cancer \[NSCLC\] (Cohort BN), SCCHN (Cohort FN).
XB002
IV administration of XB002
Nivolumab
IV administration of Nivolumab
Experimental: XB002 + Bevacizumab Dose Escalation Cohorts
Subjects (Cohort AB) will accrue in cohorts of 3-12 subjects in a modified i3+3 design.
XB002
IV administration of XB002
Bevacizumab
IV administration of bevacizumab
Interventions
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XB002
IV administration of XB002
Nivolumab
IV administration of Nivolumab
Bevacizumab
IV administration of bevacizumab
Eligibility Criteria
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Inclusion Criteria
* Dose-Escalation Stage Cohorts A, AB, and AN: The subject has received at least one systemic standard life-prolonging therapy unless it does not exist, or available therapies are intolerable or no longer effective.
* Cohort-Expansion Stage (Cohorts B - M, BN, FN and HN): The subject has received standard life-prolonging therapies unless they do not exist, or available therapies are intolerable or no longer effective.
* Cohort-Expansion Stage Cohort B and BN (Non-small Cell Lung Cancer): Subjects with Stage IV NSCLC who have documented radiographic disease progression during or following their last systemic anticancer therapy.
* Cohort-Expansion Stage Cohort D (Epithelial Ovarian Cancer): Subjects with high-grade serous ovarian cancer, including primary peritoneal cancer (PPC) and fallopian tube cancer (FTC) who have platinum-resistant disease following treatment with platinum-containing chemotherapy.
* Cohort-Expansion Stage Cohort E (Cervical Cancer): Subjects with persistent, recurrent, or metastatic carcinoma of the uterine cervix who have documented radiographic disease progression during or following their last systemic anticancer therapy.
* Cohorts F and FN (SCCHN): Subjects with head and neck cancer (squamous cell histology) who have documented radiographic disease progression during or following their last systemic anticancer therapy. Allowed primary tumor locations are oral cavity, oropharynx, hypopharynx, glottic larynx. Note: Excluded are subjects with primary tumor site of the nasopharynx.
* Cohort G (Pancreatic Cancer): Subjects with pancreatic cancer (adenocarcinoma histology) who have documented radiographic disease progression during or following their 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 last systemic anticancer therapy. Note: subjects with esophageal adenocarcinoma and adenocarcinoma of gastroesophageal junction (GEJ) are excluded.
* Cohort I (mCRPC): Subjects with metastatic, castration resistant adenocarcinoma of the prostate. Note: Neuroendocrine differentiation and other histological features are 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 2 negative \[HER-2-\]) breast cancer who have documented radiographic disease progression during or following their last systemic anticancer therapy for inoperable 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 disease progression during or following their last systemic anticancer therapy for inoperable locally advanced or metastatic disease.
* Cohort L (Endometrial Cancer): Subjects with locally advanced, recurrent or metastatic endometrial cancer who have documented radiographic disease progression during or following their last systemic anticancer therapy.
* Cohort M (Tumor-Agnostic Tissue Factor-Expressing Solid Tumors): Subjects with solid tumors other than those designated in Cohorts B-L and those which express tissue factor. Participation in this cohort will be at selected sites and countries based on site feasibility assessment.
* Expansion Cohorts: Subjects must have measurable disease per RECIST 1.1 as determined by the Investigator, except for subjects with prostate cancer without soft 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 collected from subjects enrolled in the Dose-Escalation Stage and should be collected from subjects in the Cohort-Expansion Stage.
* Recovery to baseline or ≤ Grade 1 severity (Common Terminology Criteria for Adverse Events 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 medically accepted methods of contraception.
* Female subjects of childbearing potential must not be pregnant at screening.
Exclusion Criteria
* 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.
* 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 per electrocardiogram (ECG).
* Pregnant or lactating females
* Previously identified allergy or hypersensitivity to components of study treatment formulations or history of severe infusion-related reactions to monoclonal antibodies.
* Another unresolved malignancy or a malignancy that is considered to be cured within 2 years before first dose of study treatment. Note: Subjects with superficial non-melanoma skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy within 2 years before first dose of study treatment are eligible.
18 Years
ALL
No
Sponsors
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Exelixis
INDUSTRY
Responsible Party
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Locations
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Exelixis Clinical Site #48
Birmingham, Alabama, United States
Exelixis Clinical Site #20
Tucson, Arizona, United States
Exelixis Clinical Site#95
Tucson, Arizona, United States
Exelixis Clinical Site#58
Little Rock, Arkansas, United States
Exelixis Clinical Site#59
Fountain Valley, California, United States
Exelixis Clinical Site #21
Los Angeles, California, United States
Exelixis Clinical Site #26
Los Angeles, California, United States
Exelixis Clinical Site #16
New Haven, Connecticut, United States
Exelixis Clinical Site #22
Washington D.C., District of Columbia, United States
Exelixis Clinical Site#93
Chicago, Illinois, United States
Exelixis Clinical Site #6
Baltimore, Maryland, United States
Exelixis Clinical Site #18
Columbia, Maryland, United States
Exelixis Clinical Site #25
Boston, Massachusetts, United States
Exelixis Clinical Site #19
Detroit, Michigan, United States
Exelixis Clinical Site #10
Detroit, Michigan, United States
Exelixis Clinical Site #5
St Louis, Missouri, United States
Exelixis Clinical Site #11
Omaha, Nebraska, United States
Exelixis Clinical Site #8
East Brunswick, New Jersey, United States
Exelixis Clinical Site #7
New Brunswick, New Jersey, United States
Exelixis Clinical Site #23
Albany, New York, United States
Exelixis Clinical Site#67
Lake Success, New York, United States
Exelixis Clinical Site #12
New York, New York, United States
Exelixis Clinical Site #15
Cleveland, Ohio, United States
Exelixis Clinical Site #29
Cleveland, Ohio, United States
Exelixis Clinical Site #49
Hilliard, Ohio, United States
Exelixis Clinical Site #4
Oklahoma City, Oklahoma, United States
Exelixis Clinical Site #3
Nashville, Tennessee, United States
Exelixis Clinical Site #24
Austin, Texas, United States
Exelixis Clinical Site #1
Austin, Texas, United States
Exelixis Clinical Site #32
Dallas, Texas, United States
Exelixis Clinical Site #14
Dallas, Texas, United States
Exelixis Clinical Site#92
Houston, Texas, United States
Exelixis Clinical Site #2
San Antonio, Texas, United States
Exelixis Clinical Site #9
Charlottesville, Virginia, United States
Exelixis Clinical Site#75
Miranda, New South Wales, Australia
Exelixis Clinical Site#70
Nedlands, Western Australia, Australia
Exelixis Clinical Site #37
Darlinghurst, , Australia
Exelixis Clinical Site #44
Liverpool, , Australia
Exelixis Clinical Site #35
Saint Leonards, , Australia
Exelixis Clinical Site#71
Charleroi, Hainaut, Belgium
Exelixis Clinical Site#66
Liège, Liege, Belgium
Exelixis Clinical Site#56
Brussels, , Belgium
Exelixis Clinical Site #30
Brussels, , Belgium
Exelixis Clinical Site #47
Edegem, , Belgium
Exelixis Clinical Site #38
Ghent, , Belgium
Exelixis Clinical Site#69
Lyon, Auvergne-Rhône-Alpes, France
Exelixis Clinical Site #45
Bordeaux, , France
Exelixis Clinical Site #41
Pierre-Bénite, , France
Exelixis Clinical Site#68
Poitiers, , France
Exelixis Clinical Site #50
Rennes, , France
Exelixis Clinical Site#63
Strasbourg, , France
Exelixis Clinical Site#53
Villejuif, , France
Exelixis Clinical Site#87
Paris, Île-de-France Region, France
Exelixis Clinical Site#62
Milan, MI, Italy
Exelixis Clinical Site #54
Ancona, , Italy
Exelixis Clinical Site#60
Florence, , Italy
Exelixis Clinical Site#84
Milan, , Italy
Exelixis Clinical Site #40
Roma, , Italy
Exelixis Clinical Site#90
Roma, , Italy
Exelixis Clinical Site #34
Rozzano, , Italy
Exelixis Clinical Site#61
Siena, , Italy
Exelixis Clinical Site#73
Amsterdam, North Holland, Netherlands
Exelixis Clinical Site#76
Rotterdam, South Holland, Netherlands
Exelixis Clinical Site#65
Groningen, , Netherlands
Exelixis Clinical Site #39
Maastricht, , Netherlands
Exelixis Clinical Site#79
Anyang-si, Gyeonggi-do, South Korea
Exelixis Clinical Site#80
Seongnam-si, Gyeonggi-do, South Korea
Exelixis Clinical Site#74
Seongnam-si, Gyeonggido, South Korea
Exelixis Clinical Site#83
Suwon, Gyeonggido, South Korea
Exelixis Clinical Site#86
Pusan, Gyeongsangnam-do, South Korea
Exelixis Clinical Site#78
Hwasun, Jeonranamdo, South Korea
Exelixis Clinical Site#77
Seoul, Seoul Teugbyeolsi, South Korea
Exelixis Clinical Site#94
Seoul, Seoul Teugbyeolsi, South Korea
Exelixis Clinical Site#81
Seoul, Seoul Teugbyeolsi, South Korea
Exelixis Clinical Site#85
Seoul, Seoul Teugbyeolsi, South Korea
Exelixis Clinical Site #27
Barcelona, , Spain
Exelixis Clinical Site #36
Barcelona, , Spain
Exelixis Clinical Site#55
Barcelona, , Spain
Exelixis Clinical Site#82
Barcelona, , Spain
Exelixis Clinical Site #31
Lleida, , Spain
Exelixis Clinical Site#64
Madrid, , Spain
Exelixis Clinical Site #17
Madrid, , Spain
Exelixis Clinical Site #33
Madrid, , Spain
Exelixis Clinical Site #42
Madrid, , Spain
Exelixis Clinical Site #13
Madrid, , Spain
Exelixis Clinical Site #46
Málaga, , Spain
Exelixis Clinical Site #43
Valencia, , Spain
Exelixis Clinical Site #51
Valencia, , Spain
Exelixis Clinical Site#72
Zaragoza, , Spain
Exelixis Clinical Site#88
Leicester, England, United Kingdom
Exelixis Clinical Site#89
London, England, United Kingdom
Exelixis Clinical Site#91
Cardiff, Wales, United Kingdom
Exelixis Clinical Site #52
Glasgow, , United Kingdom
Exelixis Clinical Site#57
London, , United Kingdom
Exelixis Clinical Site #28
Newcastle upon Tyne, , United Kingdom
Countries
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Other Identifiers
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XB002-101
Identifier Type: -
Identifier Source: org_study_id
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