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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04925284
Other study ID # XB002-101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date June 7, 2021
Est. completion date October 7, 2024

Study information

Verified date February 2024
Source Exelixis
Contact Exelixis Clinical Trials
Phone 1-888-EXELIXIS (888-393-5494)
Email druginfo@exelixis.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 to subjects with advanced solid tumors.


Recruitment information / eligibility

Status Recruiting
Enrollment 573
Est. completion date October 7, 2024
Est. primary completion date June 7, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
XB002
IV administration of XB002
Nivolumab
IV administration of Nivolumab

Locations

Country Name City State
Australia Exelixis Clinical Site #37 Darlinghurst
Australia Exelixis Clinical Site #44 Liverpool
Australia Exelixis Clinical Site#75 Miranda New South Wales
Australia Exelixis Clinical Site#70 Nedlands Western Australia
Australia Exelixis Clinical Site #35 Saint Leonards
Belgium Exelixis Clinical Site #30 Brussels
Belgium Exelixis Clinical Site#56 Brussels
Belgium Exelixis Clinical Site#71 Charleroi Hainaut
Belgium Exelixis Clinical Site #47 Edegem
Belgium Exelixis Clinical Site #38 Gent
Belgium Exelixis Clinical Site#66 Liège Liege
France Exelixis Clinical Site #45 Bordeaux
France Exelixis Clinical Site#69 Lyon Rhone-Alpes
France Exelixis Clinical Site#87 Paris Ile-de-France
France Exelixis Clinical Site #41 Pierre Benite
France Exelixis Clinical Site#68 Poitiers
France Exelixis Clinical Site #50 Rennes
France Exelixis Clinical Site#63 Strasbourg
France Exelixis Clinical Site#53 Villejuif
Italy Exelixis Clinical Site #54 Ancona
Italy Exelixis Clinical Site#60 Firenze
Italy Exelixis Clinical Site#84 Milan
Italy Exelixis Clinical Site#62 Milano MI
Italy Exelixis Clinical Site #40 Roma
Italy Exelixis Clinical Site#90 Roma
Italy Exelixis Clinical Site #34 Rozzano
Italy Exelixis Clinical Site#61 Siena
Korea, Republic of Exelixis Clinical Site#79 Anyang-si Gyeonggi-do
Korea, Republic of Exelixis Clinical Site#86 Busan Gyeongsangnam-do
Korea, Republic of Exelixis Clinical Site#78 Hwasun Jeonranamdo [Chollanam-do]
Korea, Republic of Exelixis Clinical Site#74 Seongnam-si Gyeonggido [Kyonggi-do]
Korea, Republic of Exelixis Clinical Site#80 Seongnam-si Gyeonggi-Do
Korea, Republic of Exelixis Clinical Site#77 Seoul Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
Korea, Republic of Exelixis Clinical Site#81 Seoul Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
Korea, Republic of Exelixis Clinical Site#85 Seoul Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
Korea, Republic of Exelixis Clinical Site#83 Suwon Gyeonggido [Kyonggi-do]
Netherlands Exelixis Clinical Site#73 Amsterdam Noord-Holland
Netherlands Exelixis Clinical Site#65 Groningen
Netherlands Exelixis Clinical Site #39 Maastricht
Netherlands Exelixis Clinical Site#76 Rotterdam Zuid-Holland
Spain 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 #13 Madrid
Spain Exelixis Clinical Site #17 Madrid
Spain Exelixis Clinical Site #33 Madrid
Spain Exelixis Clinical Site #42 Madrid
Spain Exelixis Clinical Site#64 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
United Kingdom Exelixis Clinical Site#91 Cardiff Wales
United Kingdom Exelixis Clinical Site #52 Glasgow
United Kingdom Exelixis Clinical Site#88 Leicester England
United Kingdom Exelixis Clinical Site#57 London
United Kingdom Exelixis Clinical Site#89 London England
United Kingdom Exelixis Clinical Site #28 Newcastle Upon Tyne
United States Exelixis Clinical Site #23 Albany New York
United States Exelixis Clinical Site #1 Austin Texas
United States Exelixis Clinical Site #24 Austin Texas
United States Exelixis Clinical Site #6 Baltimore Maryland
United States Exelixis Clinical Site #48 Birmingham Alabama
United States Exelixis Clinical Site #25 Boston Massachusetts
United States Exelixis Clinical Site #9 Charlottesville Virginia
United States Exelixis Clinical Site #15 Cleveland Ohio
United States Exelixis Clinical Site #29 Cleveland Ohio
United States Exelixis Clinical Site #18 Columbia Maryland
United States Exelixis Clinical Site #14 Dallas Texas
United States Exelixis Clinical Site #32 Dallas Texas
United States Exelixis Clinical Site #10 Detroit Michigan
United States Exelixis Clinical Site #19 Detroit Michigan
United States Exelixis Clinical Site #8 East Brunswick New Jersey
United States Exelixis Clinical Site#59 Fountain Valley California
United States Exelixis Clinical Site #49 Hilliard Ohio
United States Exelixis Clinical Site#92 Houston Texas
United States Exelixis Clinical Site#67 Lake Success New York
United States Exelixis Clinical Site#58 Little Rock Arkansas
United States Exelixis Clinical Site #21 Los Angeles California
United States Exelixis Clinical Site #26 Los Angeles California
United States Exelixis Clinical Site #3 Nashville Tennessee
United States Exelixis Clinical Site #7 New Brunswick New Jersey
United States Exelixis Clinical Site #16 New Haven Connecticut
United States Exelixis Clinical Site #12 New York New York
United States Exelixis Clinical Site #4 Oklahoma City Oklahoma
United States Exelixis Clinical Site #11 Omaha Nebraska
United States Exelixis Clinical Site #5 Saint Louis Missouri
United States Exelixis Clinical Site #2 San Antonio Texas
United States Exelixis Clinical Site #20 Tucson Arizona
United States Exelixis Clinical Site #22 Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Exelixis

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Italy,  Korea, Republic of,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dose-Escalation Stage: MTD/recommended dose for XB002 To determine the MTD and/or RD for further evaluation of IV administration of XB002 alone and in combination therapy in subjects with advanced malignancies 18 months
Primary Cohort-Expansion Stage: Objective Response Rate (ORR) To evaluate preliminary efficacy of XB002 when administered alone and in combination therapy by determining the ORR per RECIST 1.1 (or other applicable response criteria eg. RANO or PCWG3 criteria) as assessed by the Investigator 12 months
Secondary Safety of XB002: Adverse Events To evaluate the safety of XB002 through the evaluation of incidence and severity of nonserious adverse events (AEs) and serious adverse events (SAEs) 30 months
Secondary Tolerability of XB002 as evaluated by the duration of exposure for the study To evaluate the tolerability of XB002 through the evaluation of duration of exposure for the study treatment 30 months
Secondary Tolerability of XB002 as evaluated dose intensity of the study treatment To evaluate the tolerability of XB002 through the evaluation of dose intensity of the study treatment 30 months
Secondary Maximum Plasma Concentration (Cmax) To evaluate the Cmax for XB002, total antibody, and free payload at scheduled visits over time 30 months
Secondary Trough Concentration (Ctrough) To evaluate the Ctrough of XB002, total antibody, and free payload at scheduled visits over time 30 months
Secondary Immunogenicity of XB002 To assess the immunogenicity of XB002 as measured by anti-drug antibody (ADA) analysis 30 months
Secondary Anti-tumor activity of XB002: Objective Response Rate (ORR) To evaluate the anti-tumor activity of XB002, as measured by ORR, per RECIST 1.1 (or other applicable response criteria eg. RANO or PCWG3 criteria) as assessed by the Investigator (dose escalation stage) or by a BIRC for selected cohorts (cohort expansion stage). 30 months
Secondary Anti-tumor activity of XB002: Duration of Response (DOR) To evaluate the anti-tumor activity of XB002, as measured by DOR, per RECIST 1.1 (or other applicable response criteria eg. RANO or PCWG3 criteria) as assessed by the Investigator (dose escalation stage) or by a BIRC for selected cohorts (cohort expansion stage) 30 months
Secondary Anti-tumor activity of XB002: Progression Free Survival (PFS) To evaluate the anti-tumor activity of XB002, as measured by PFS, per RECIST 1.1 (or other applicable response criteria eg. RANO or PCWG3 criteria) as assessed by the Investigator (dose escalation stage) or by a BIRC for selected cohorts (cohort expansion stage) 30 months
Secondary Cohort-Expansion Stage: overall survival To evaluate overall survival 12 months
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