Brief Summary
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.
Brief Title
Study of XB010 in Subjects With Solid Tumors
Detailed Description
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.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
1-888-EXELIXIS (888-393-5494)
Central Contact Email
druginfo@exelixis.com
Central Contact Role
Contact
Central Contact Phone
650-837-7400
Completion Date
Completion Date Type
Estimated
Conditions
LOCALLY ADVANCED OR METASTATIC SOLID TUMORS
ESOPHAGEAL SQUAMOUS CELL CANCER
HEAD AND NECK SQUAMOUS CELL CANCER
NSCLC (NON-SMALL CELL LUNG CANCER)
HORMONE-RECEPTOR-POSITIVE BREAST CANCER
TRIPLE NEGATIVE BREAST CANCER (TNBC)
Eligibility Criteria
* 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.
* The Cohort Expansion stage will enroll subjects with multiple tumor types (non-small cell lung cancer, hormone-receptor-positive breast cancer, head and neck cancer, esophageal squamous cell, triple-negative breast cancer).
* Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.
* 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.
* The Cohort Expansion stage will enroll subjects with multiple tumor types (non-small cell lung cancer, hormone-receptor-positive breast cancer, head and neck cancer, esophageal squamous cell, triple-negative breast cancer).
* Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.
Inclusion Criteria
* 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.
* The Cohort Expansion stage will enroll subjects with multiple tumor types (non-small cell lung cancer, hormone-receptor-positive breast cancer, head and neck cancer, esophageal squamous cell, triple-negative breast cancer).
* Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.
* 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.
* The Cohort Expansion stage will enroll subjects with multiple tumor types (non-small cell lung cancer, hormone-receptor-positive breast cancer, head and neck cancer, esophageal squamous cell, triple-negative breast cancer).
* Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06545331
Org Class
Industry
Org Full Name
Exelixis
Org Study Id
XB010-101
Overall Status
Recruiting
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Dose-Escalation and Expansion Study of XB010 as a Single Agent and Combination Therapy in Subjects With Locally Advanced or Metastatic Solid Tumors
Primary Outcomes
Outcome Description
To determine the MTD and/or RDE(s) for further evaluation of IV administration of XB010 alone and in combination therapy.
Outcome Measure
Dose-Escalation Stage: Maximum tolerated dose (MTD) and/or Recommended dose(s) for Expansion [RDE(s)] for XB010
Outcome Time Frame
18 months
Outcome Description
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)
Outcome Measure
Dose-Escalation Stage: Safety of XB010
Outcome Time Frame
18 months
Outcome Description
To evaluate the tolerability of XB010 alone and in combination therapy through the evaluation of the duration of exposure of each component
Outcome Measure
Dose-Escalation Stage: Duration of exposure of XB010 [Tolerability]
Outcome Time Frame
18 months
Outcome Description
To evaluate the tolerability of XB010 alone and in combination therapy through the evaluation of the dose intensity of each component
Outcome Measure
Dose-Escalation Stage: Dose intensity of XB010 [Tolerability]
Outcome Time Frame
18 months
Outcome Description
Objective Response Rate (ORR) as assessed by the Investigator per RECIST 1.1
Outcome Measure
Cohort-Expansion Stage: Preliminary antitumor activity of XB010
Outcome Time Frame
24 months
Secondary Ids
Secondary Id
1012465
Secondary Outcomes
Outcome Description
To evaluate the maximum plasma concentration of XB010 alone and in combination.
Outcome Time Frame
18 Months
Outcome Measure
Dose-Escalation Stage: Maximum Plasma Concentration (Cmax) of XB010
Outcome Description
To evaluate the time to maximum plasma concentration of XB010 alone and in combination.
Outcome Time Frame
18 Months
Outcome Measure
Dose-Escalation Stage: Time to Maximum Plasma Concentration (Tmax) of XB010
Outcome Description
To evaluate the volume of plasma cleared of XB010 alone and in combination for a specified time period
Outcome Time Frame
18 Months
Outcome Measure
Dose-Escalation Stage: Clearance of XB010
Outcome Description
To measure the Area Under the Plasma Concentration Curve of XB010 alone and in combination
Outcome Time Frame
18 Months
Outcome Measure
Dose-Escalation Stage: Area Under the Plasma Concentration Curve (AUC) of XB010
Outcome Description
To evaluate the minimum plasma concentration of XB010 alone and in combination
Outcome Time Frame
18 Months
Outcome Measure
Dose-Escalation Stage: Minimum Plasma Concentration (Cmin) of XB010
Outcome Description
To assess the immunogenicity of XB010 alone and in combination as measured by anti-drug antibody (ADA) analysis
Outcome Time Frame
18 Months
Outcome Measure
Dose-Escalation Stage: Immunogenicity of XB010
Outcome Description
To evaluate the tolerability of XB010 through the evaluation of the duration of exposure
Outcome Time Frame
24 Months
Outcome Measure
Cohort-Expansion Stage: Duration of exposure of XB010 [Tolerability]
Outcome Description
To evaluate the tolerability of XB010 through the evaluation of the dose intensity
Outcome Time Frame
24 Months
Outcome Measure
Cohort-Expansion Stage: Dose intensity of XB010 [Tolerability]
Outcome Description
To evaluate the maximum plasma concentration of XB010
Outcome Time Frame
24 Months
Outcome Measure
Cohort-Expansion Stage: Maximum Plasma Concentration (Cmax) of XB010
Outcome Description
To evaluate the time to maximum plasma concentration of XB010
Outcome Time Frame
24 Months
Outcome Measure
Cohort-Expansion Stage: Time to Maximum Plasma Concentration (Tmax) of XB010
Outcome Description
To evaluate the volume of plasma cleared of XB010 for a specified time period
Outcome Time Frame
24 Months
Outcome Measure
Cohort-Expansion Stage: Clearance of XB010
Outcome Description
To measure the Area Under the Plasma Concentration Curve of XB010
Outcome Time Frame
24 Months
Outcome Measure
Cohort-Expansion Stage: Area Under the Plasma Concentration Curve (AUC) of XB010
Outcome Description
To evaluate the minimum plasma concentration of XB010
Outcome Time Frame
24 Months
Outcome Measure
Cohort-Expansion Stage: Minimum Plasma Concentration (Cmin) of XB010
Outcome Description
To assess the immunogenicity of XB010 as measured by anti-drug antibody (ADA) analysis
Outcome Time Frame
24 Months
Outcome Measure
Cohort-Expansion Stage: Immunogenicity of XB010
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
David Levitz
Investigator Email
dlevitz@montefiore.org
Investigator Sponsor Organization
External
Study Department
Medical Student
Study Division
Not Applicable
Categories Mesh Debug
Lung & Chest Cancers --- CARCINOMA, NON-SMALL-CELL LUNG
Breast Cancer --- TRIPLE NEGATIVE BREAST NEOPLASMS
Cancer --- CARCINOMA
Cancer --- NEOPLASMS
Gastrointestinal (GI) Cancers --- GASTROINTESTINAL NEOPLASMS
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Digestive System --- DIGESTIVE SYSTEM DISEASES
Liver --- DIGESTIVE SYSTEM DISEASES
Digestive System --- GASTROINTESTINAL DISEASES
Lung & Chest Cancers --- CARCINOMA, BRONCHOGENIC
Lung & Chest Cancers --- BRONCHIAL NEOPLASMS
Lung & Chest Cancers --- LUNG NEOPLASMS
Lung & Chest Cancers --- RESPIRATORY TRACT NEOPLASMS
Lung & Chest Cancers --- THORACIC NEOPLASMS
COVID-19 --- LUNG DISEASES
Lung --- LUNG DISEASES
Asthma and Other Respiratory Diseases --- RESPIRATORY TRACT DISEASES
COVID-19 --- RESPIRATORY TRACT DISEASES
Lung --- RESPIRATORY TRACT DISEASES
Breast Cancer --- BREAST NEOPLASMS
MeSH Terms
ESOPHAGEAL SQUAMOUS CELL CARCINOMA
CARCINOMA, NON-SMALL-CELL LUNG
TRIPLE NEGATIVE BREAST NEOPLASMS
CARCINOMA, SQUAMOUS CELL
CARCINOMA
NEOPLASMS, GLANDULAR AND EPITHELIAL
NEOPLASMS BY HISTOLOGIC TYPE
NEOPLASMS
NEOPLASMS, SQUAMOUS CELL
ESOPHAGEAL NEOPLASMS
GASTROINTESTINAL NEOPLASMS
DIGESTIVE SYSTEM NEOPLASMS
NEOPLASMS BY SITE
HEAD AND NECK NEOPLASMS
DIGESTIVE SYSTEM DISEASES
ESOPHAGEAL DISEASES
GASTROINTESTINAL DISEASES
CARCINOMA, BRONCHOGENIC
BRONCHIAL NEOPLASMS
LUNG NEOPLASMS
RESPIRATORY TRACT NEOPLASMS
THORACIC NEOPLASMS
LUNG DISEASES
RESPIRATORY TRACT DISEASES
BREAST NEOPLASMS
BREAST DISEASES
SKIN DISEASES
SKIN AND CONNECTIVE TISSUE DISEASES
PEMBROLIZUMAB