Breast Cancer Clinical Trial
Study of XB002 in Subjects With Solid Tumors (JEWEL-101)
Summary
This is a Phase 1, non-randomized, 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 to subjects with advanced solid tumors.
Eligibility Criteria
Inclusion Criteria:
Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent.
Dose-Escalation Stage Cohorts A and AN: The subject has received atleast 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.
Cohorts H and HN (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:
Receipt of prior therapies as defined in study protocol
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.
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There are 75 Locations for this study
Birmingham Alabama, 35294, United States
Tucson Arizona, 85704, United States
Little Rock Arkansas, 72205, United States
Fountain Valley California, 92708, United States
Los Angeles California, 90025, United States
Los Angeles California, 90404, United States
New Haven Connecticut, 06511, United States
Washington District of Columbia, 20007, United States
Baltimore Maryland, 21287, United States
Columbia Maryland, 21044, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48202, United States
Detroit Michigan, 49201, United States
Saint Louis Missouri, 63110, United States
Omaha Nebraska, 68130, United States
East Brunswick New Jersey, 08816, United States
New Brunswick New Jersey, 08903, United States
Albany New York, 12206, United States
Lake Success New York, 11042, United States
New York New York, 10016, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44195, United States
Hilliard Ohio, 43026, United States
Oklahoma City Oklahoma, 73104, United States
Nashville Tennessee, 37203, United States
Austin Texas, 78705, United States
Austin Texas, 78758, United States
Dallas Texas, 75246, United States
Dallas Texas, 75390, United States
San Antonio Texas, 78229, United States
Charlottesville Virginia, 22903, United States
Miranda New South Wales, 2228, Australia
Nedlands Western Australia, 6009, Australia
Darlinghurst , 2010, Australia
Liverpool , 2170, Australia
Saint Leonards , 2065, Australia
Charleroi Hainaut, 6000, Belgium
Liège Liege, 4000, Belgium
Brussels , 1070, Belgium
Brussels , 1200, Belgium
Edegem , 2650, Belgium
Gent , 9000, Belgium
Lyon Rhone-Alpes, 69373, France
Bordeaux , 33000, France
Pierre Benite , 69310, France
Poitiers , 86000, France
Rennes , 35042, France
Strasbourg , 67200, France
Villejuif , 94805, France
Milano MI, 20141, Italy
Ancona , 60126, Italy
Firenze , 50134, Italy
Roma , 00144, Italy
Rozzano , 20089, Italy
Siena , 53100, Italy
Seongnam-si Gyeonggido [Kyonggi-do], 13620, Korea, Republic of
Amsterdam Noord-Holland, 1066 , Netherlands
Groningen , 9713 , Netherlands
Maastricht , 6229 , Netherlands
Barcelona , 08023, Spain
Barcelona , 08028, Spain
Barcelona , 8035, Spain
Lleida , 25198, Spain
Madrid , 1217, Spain
Madrid , 28027, Spain
Madrid , 28040, Spain
Madrid , 28050, Spain
Madrid , 28223, Spain
Málaga , 29010, Spain
Valencia , 46010, Spain
Valencia , 46026, Spain
Zaragoza , 50009, Spain
Glasgow , G12 0, United Kingdom
London , W1T 7, United Kingdom
Newcastle Upon Tyne , NE7 7, United Kingdom
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