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NCT Number: NCT06545331

Study of XB010 in Subjects With Solid Tumors

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.

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Key information

Conditions

Locally Advanced or Metastatic Solid Tumors Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Esophageal Squamous Cell Cancer Esophageal Squamous Cell Carcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Head and Neck Squamous Cell Cancer Hormone-receptor-positive Breast Cancer Lung Diseases Lung Neoplasms NSCLC (Non-small Cell Lung Cancer) Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Triple Negative Breast Cancer (TNBC) Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Hospitals of Leicester NHS Trust, Leicester, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

XB010

Drug

IV administration of XB010

Pembrolizumab

Drug

IV administration of Pembrolizumab

Primary outcomes

  1. Dose-Escalation Stage: Maximum tolerated dose (MTD) and/or Recommended dose(s) for Expansion [RDE(s)] for XB010

    Time frame: 18 months

    To determine the MTD and/or RDE(s) for further evaluation of IV administration of XB010 alone and in combination therapy.

  2. Dose-Escalation Stage: Safety of XB010

    Time frame: 18 months

    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)

  3. Dose-Escalation Stage: Duration of exposure of XB010 [Tolerability]

    Time frame: 18 months

    To evaluate the tolerability of XB010 alone and in combination therapy through the evaluation of the duration of exposure of each component

  4. Dose-Escalation Stage: Dose intensity of XB010 [Tolerability]

    Time frame: 18 months

    To evaluate the tolerability of XB010 alone and in combination therapy through the evaluation of the dose intensity of each component

  5. Cohort-Expansion Stage: Preliminary antitumor activity of XB010

    Time frame: 24 months

    Objective Response Rate (ORR) as assessed by the Investigator per RECIST 1.1

Secondary outcomes

  1. Dose-Escalation Stage: Maximum Plasma Concentration (Cmax) of XB010

    Time frame: 18 Months

    To evaluate the maximum plasma concentration of XB010 alone and in combination.

  2. Dose-Escalation Stage: Time to Maximum Plasma Concentration (Tmax) of XB010

    Time frame: 18 Months

    To evaluate the time to maximum plasma concentration of XB010 alone and in combination.

  3. Dose-Escalation Stage: Clearance of XB010

    Time frame: 18 Months

    To evaluate the volume of plasma cleared of XB010 alone and in combination for a specified time period

  4. Dose-Escalation Stage: Area Under the Plasma Concentration Curve (AUC) of XB010

    Time frame: 18 Months

    To measure the Area Under the Plasma Concentration Curve of XB010 alone and in combination

  5. Dose-Escalation Stage: Minimum Plasma Concentration (Cmin) of XB010

    Time frame: 18 Months

    To evaluate the minimum plasma concentration of XB010 alone and in combination

  6. Dose-Escalation Stage: Immunogenicity of XB010

    Time frame: 18 Months

    To assess the immunogenicity of XB010 alone and in combination as measured by anti-drug antibody (ADA) analysis

  7. Cohort-Expansion Stage: Duration of exposure of XB010 [Tolerability]

    Time frame: 24 Months

    To evaluate the tolerability of XB010 through the evaluation of the duration of exposure

  8. Cohort-Expansion Stage: Dose intensity of XB010 [Tolerability]

    Time frame: 24 Months

    To evaluate the tolerability of XB010 through the evaluation of the dose intensity

  9. Cohort-Expansion Stage: Maximum Plasma Concentration (Cmax) of XB010

    Time frame: 24 Months

    To evaluate the maximum plasma concentration of XB010

  10. Cohort-Expansion Stage: Time to Maximum Plasma Concentration (Tmax) of XB010

    Time frame: 24 Months

    To evaluate the time to maximum plasma concentration of XB010

  11. Cohort-Expansion Stage: Clearance of XB010

    Time frame: 24 Months

    To evaluate the volume of plasma cleared of XB010 for a specified time period

  12. Cohort-Expansion Stage: Area Under the Plasma Concentration Curve (AUC) of XB010

    Time frame: 24 Months

    To measure the Area Under the Plasma Concentration Curve of XB010

  13. Cohort-Expansion Stage: Minimum Plasma Concentration (Cmin) of XB010

    Time frame: 24 Months

    To evaluate the minimum plasma concentration of XB010

  14. Cohort-Expansion Stage: Immunogenicity of XB010

    Time frame: 24 Months

    To assess the immunogenicity of XB010 as measured by anti-drug antibody (ADA) analysis

Study contacts

Contact information is provided by the study sponsor or research team.

Backup or International

CONTACT

650-837-7400

Exelixis Clinical Trials

CONTACT

[email protected]

1-888-EXELIXIS (888-393-5494)

Sponsors and collaborators

Lead sponsor

Exelixis

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 9, 2024
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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