Study of XB010 in Subjects With Solid Tumors
Purpose
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.
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
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental XB010 Single-Agent Dose Escalation Cohorts |
XB010 will be administered at escalating dose levels every 3 weeks in cohorts of 3-12 subjects |
|
|
Experimental XB010 + Pembrolizumab Dose Escalation Cohorts |
XB010+Pembrolizumab will be administered at escalating dose levels every 3 weeks in cohorts of 3-12 subjects |
|
|
Experimental XB010 Single-Agent Dose Expansion Cohorts |
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) |
|
Recruiting Locations
Irvine, California 92618
Washington D.C., District of Columbia 20007
Atlanta, Georgia 30322
Chicago, Illinois 60637
St Louis, Missouri 63110
Huntersville, North Carolina 28078
Oklahoma City, Oklahoma 73104
Nashville, Tennessee 37203
Austin, Texas 78758
Dallas, Texas 74246
Houston, Texas 77030
Fairfax, Virginia 22031
Fairfax, Virginia 22031
More Details
- Status
- Recruiting
- Sponsor
- Exelixis
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.