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

ArmDescriptionAssigned 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
  • Drug: XB010
    IV administration of XB010
Experimental
XB010 + Pembrolizumab Dose Escalation Cohorts 		XB010+Pembrolizumab will be administered at escalating dose levels every 3 weeks in cohorts of 3-12 subjects
  • Drug: XB010
    IV administration of XB010
  • Drug: Pembrolizumab
    IV administration of Pembrolizumab
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)
  • Drug: XB010
    IV administration of XB010

Recruiting Locations

Exelixis Clinical Site #4
Irvine, California 92618

Exelixis Clinical Site #10
Washington D.C., District of Columbia 20007

Exelixis Clinical Site #12
Atlanta, Georgia 30322

Exelixis Clinical Site #15
Chicago, Illinois 60637

Exelixis Clinical Site #5
St Louis, Missouri 63110

Exelixis Clinical Site #3
Huntersville, North Carolina 28078

Exelixis Clinical Site #6
Oklahoma City, Oklahoma 73104

Exelixis Clinical Site #9
Nashville, Tennessee 37203

Exelixis Clinical Site #1
Austin, Texas 78758

Exelixis Clinical Site #7
Dallas, Texas 74246

Exelixis Clinical Site #8
Houston, Texas 77030

Exelixis Clinical Site #11
Fairfax, Virginia 22031

Exelixis Clinical Site #2
Fairfax, Virginia 22031

More Details

Status
Recruiting
Sponsor
Exelixis

Study Contact

Exelixis Clinical Trials
1-888-EXELIXIS (888-393-5494)
druginfo@exelixis.com

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.