Recruiting
Phase 1

XB010

Sponsor:

Exelixis

Code:

NCT06545331

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

XB010

Pembrolizumab

Study Details

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.

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

Study ID

NCT06545331

Start date

Aug 6, 2024

Status verified date

Jun, 2026

Completion date

Oct 20, 2027

Anticipated

Primary completion date

Nov 23, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

  • 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

Enrollment

396 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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)

Interventions

XB010

IV administration of XB010

Pembrolizumab

IV administration of Pembrolizumab

Primary outcome measure

  • Dose-Escalation Stage: Maximum tolerated dose (MTD) and/or Recommended dose(s) for Expansion [RDE(s)] for XB010 [ Time Frame: 18 months ]
  • Dose-Escalation Stage: Safety of XB010 [ Time Frame: 18 months ]
  • Dose-Escalation Stage: Duration of exposure of XB010 [Tolerability] [ Time Frame: 18 months ]
  • Dose-Escalation Stage: Dose intensity of XB010 [Tolerability] [ Time Frame: 18 months ]
  • Cohort-Expansion Stage: Preliminary antitumor activity of XB010 [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Exelixis Clinical Trials

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

Backup or International

650-837-7400

Locations

City of Hope Orange County Lennar Foundation Cancer Center

Recruiting

Irvine, California, United States, 91010

UCLA Department of Medicine - Hematology/Oncology

Recruiting

Los Angeles, California, United States, 90095

Georgetown University Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20007

Sarah Cannon Research Institute at Florida Cancer Specialists

Recruiting

Orlando, Florida, United States, 32827

Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Siteman Cancer Center

Recruiting

St Louis, Missouri, United States, 63110

Montefiore Medical Center - Montefiore Medical Park

Recruiting

The Bronx, New York, United States, 10461

Carolina BioOncology Institute

Recruiting

Huntersville, North Carolina, United States, 28078

Stephenson Cancer Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

NEXT Austin

Recruiting

Austin, Texas, United States, 78758

Baylor University Medical Center

Recruiting

Dallas, Texas, United States, 75246

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Inova Schar Cancer

Recruiting

Fairfax, Virginia, United States, 22031

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Exelixis

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Exelixis on 2026-06-22.