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| ID | Type | Description | Link |
|---|---|---|---|
| 1012465 | Other Identifier | IRAS |
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This is a FIH study is to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of XB010 as a single agent and in combination with pembrolizumab in subjects with locally advanced or metastatic solid tumors for whom alternative therapies do not exist or available therapies are intolerable or no longer effective.
This study consists of Dose-Escalation and Cohort-Expansion Stages. The Dose-Escalation Stage is designed to determine the maximum tolerated dose (MTD) and/or recommended dosage(s) for expansion (RDE[s]) of XB010 as a single agent, and to evaluate XB010 monotherapy RDE(s) in combination with pembrolizumab. The Cohort-Expansion Stage is designed to explore the clinical activity and further characterize the safety and tolerability of XB010 as monotherapy in multiple tumor-specific cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XB010 Single-Agent Dose Escalation Cohorts | Experimental | XB010 will be administered at escalating dose levels every 3 weeks in cohorts of 3-12 subjects |
|
| XB010 + Pembrolizumab Dose Escalation Cohorts | Experimental | XB010+Pembrolizumab will be administered at escalating dose levels every 3 weeks in cohorts of 3-12 subjects |
|
| XB010 Single-Agent Dose Expansion Cohorts | Experimental | XB010 will be administered at the recommended dose for expansion (RDE) every 3 weeks in the following tumor-specific cohorts: non-small cell lung cancer (NSCLC), hormone-receptor-positive breast cancer (HR+BC), head and neck squamous cell cancer (HNSCC), esophageal squamous cell cancer (ESCC), endometrial cancer (EC) and triple-negative breast cancer (TNBC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XB010 | Drug | IV administration of XB010 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-Escalation Stage: Maximum tolerated dose (MTD) and/or Recommended dose(s) for Expansion [RDE(s)] for XB010 | To determine the MTD and/or RDE(s) for further evaluation of IV administration of XB010 alone and in combination therapy. | 18 months |
| Dose-Escalation Stage: Safety of XB010 | To evaluate the safety of XB010 alone and in combination therapy through the evaluation of incidence and severity of nonserious adverse events (AEs) and serious adverse events (SAEs) | 18 months |
| Dose-Escalation Stage: Duration of exposure of XB010 [Tolerability] | To evaluate the tolerability of XB010 alone and in combination therapy through the evaluation of the duration of exposure of each component | 18 months |
| Dose-Escalation Stage: Dose intensity of XB010 [Tolerability] | To evaluate the tolerability of XB010 alone and in combination therapy through the evaluation of the dose intensity of each component | 18 months |
| Cohort-Expansion Stage: Preliminary antitumor activity of XB010 | Objective Response Rate (ORR) as assessed by the Investigator per RECIST 1.1 | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-Escalation Stage: Maximum Plasma Concentration (Cmax) of XB010 | To evaluate the maximum plasma concentration of XB010 alone and in combination. | 18 Months |
| Dose-Escalation Stage: Time to Maximum Plasma Concentration (Tmax) of XB010 |
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Age 18 years or older on the day of consent.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
Adequate organ and marrow function.
Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent.
Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Exelixis Clinical Trials | Contact | 1-888-EXELIXIS (888-393-5494) | druginfo@exelixis.com | |
| Backup or International | Contact | 650-837-7400 |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Exelixis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Orange County Lennar Foundation Cancer Center | Recruiting | Irvine | California | 91010 | United States | |
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| Pembrolizumab | Drug | IV administration of Pembrolizumab |
|
To evaluate the time to maximum plasma concentration of XB010 alone and in combination.
| 18 Months |
| Dose-Escalation Stage: Clearance of XB010 | To evaluate the volume of plasma cleared of XB010 alone and in combination for a specified time period | 18 Months |
| Dose-Escalation Stage: Area Under the Plasma Concentration Curve (AUC) of XB010 | To measure the Area Under the Plasma Concentration Curve of XB010 alone and in combination | 18 Months |
| Dose-Escalation Stage: Minimum Plasma Concentration (Cmin) of XB010 | To evaluate the minimum plasma concentration of XB010 alone and in combination | 18 Months |
| Dose-Escalation Stage: Immunogenicity of XB010 | To assess the immunogenicity of XB010 alone and in combination as measured by anti-drug antibody (ADA) analysis | 18 Months |
| Cohort-Expansion Stage: Duration of exposure of XB010 [Tolerability] | To evaluate the tolerability of XB010 through the evaluation of the duration of exposure | 24 Months |
| Cohort-Expansion Stage: Dose intensity of XB010 [Tolerability] | To evaluate the tolerability of XB010 through the evaluation of the dose intensity | 24 Months |
| Cohort-Expansion Stage: Maximum Plasma Concentration (Cmax) of XB010 | To evaluate the maximum plasma concentration of XB010 | 24 Months |
| Cohort-Expansion Stage: Time to Maximum Plasma Concentration (Tmax) of XB010 | To evaluate the time to maximum plasma concentration of XB010 | 24 Months |
| Cohort-Expansion Stage: Clearance of XB010 | To evaluate the volume of plasma cleared of XB010 for a specified time period | 24 Months |
| Cohort-Expansion Stage: Area Under the Plasma Concentration Curve (AUC) of XB010 | To measure the Area Under the Plasma Concentration Curve of XB010 | 24 Months |
| Cohort-Expansion Stage: Minimum Plasma Concentration (Cmin) of XB010 | To evaluate the minimum plasma concentration of XB010 | 24 Months |
| Cohort-Expansion Stage: Immunogenicity of XB010 | To assess the immunogenicity of XB010 as measured by anti-drug antibody (ADA) analysis | 24 Months |
| UCLA Department of Medicine - Hematology/Oncology |
| Recruiting |
| Los Angeles |
| California |
| 90095 |
| United States |
| Georgetown University Medical Center | Recruiting | Washington D.C. | District of Columbia | 20007 | United States |
| Sarah Cannon Research Institute at Florida Cancer Specialists | Recruiting | Orlando | Florida | 32827 | United States |
| Winship Cancer Institute | Recruiting | Atlanta | Georgia | 30322 | United States |
| University of Chicago Medical Center | Recruiting | Chicago | Illinois | 60637 | United States |
| Siteman Cancer Center | Recruiting | St Louis | Missouri | 63110 | United States |
| Montefiore Medical Center - Montefiore Medical Park | Recruiting | The Bronx | New York | 10461 | United States |
| Carolina BioOncology Institute | Recruiting | Huntersville | North Carolina | 28078 | United States |
| Stephenson Cancer Center | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
| SCRI Oncology Partners | Recruiting | Nashville | Tennessee | 37203 | United States |
| NEXT Austin | Recruiting | Austin | Texas | 78758 | United States |
| Baylor University Medical Center | Recruiting | Dallas | Texas | 75246 | United States |
| University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| Inova Schar Cancer | Recruiting | Fairfax | Virginia | 22031 | United States |
| NEXT Virginia | Recruiting | Fairfax | Virginia | 22031 | United States |
| University Hospitals of Leicester NHS Trust | Recruiting | Leicester | LE1 5WW | United Kingdom |
| Sarah Cannon Research Institute London | Recruiting | London | W1G 6AD | United Kingdom |
| University College London Hospitals NHS Foundation Trust | Recruiting | London | W1T 7HA | United Kingdom |
| The Christie NHS Foundation Trust | Recruiting | Manchester | M20 4BX | United Kingdom |
| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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