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Recruiting NCT06545331

Study of XB010 in Subjects With Solid Tumors

Phase I Interventional Locally Advanced or Metastatic Solid Tumors Esophageal Squamous Cell Cancer Head and Neck Squamous Cell Cancer NSCLC (Non-small Cell Lung Cancer)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: XB010, Pembrolizumab.
Who it may be relevant to
Registry conditions: Locally Advanced or Metastatic Solid Tumors, Esophageal Squamous Cell Cancer, Head and Neck Squamous Cell Cancer, NSCLC (Non-small Cell Lung Cancer). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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.

Interventions

  • Drug XB010
    IV administration of XB010
  • Drug Pembrolizumab
    IV administration of Pembrolizumab

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • Dose-Escalation Stage: Maximum Plasma Concentration (Cmax) of XB010 [Time frame: 18 Months]
  • Dose-Escalation Stage: Time to Maximum Plasma Concentration (Tmax) of XB010 [Time frame: 18 Months]
  • Dose-Escalation Stage: Clearance of XB010 [Time frame: 18 Months]
  • Dose-Escalation Stage: Area Under the Plasma Concentration Curve (AUC) of XB010 [Time frame: 18 Months]
  • Dose-Escalation Stage: Minimum Plasma Concentration (Cmin) of XB010 [Time frame: 18 Months]
  • Dose-Escalation Stage: Immunogenicity of XB010 [Time frame: 18 Months]
  • Cohort-Expansion Stage: Duration of exposure of XB010 [Tolerability] [Time frame: 24 Months]
  • Cohort-Expansion Stage: Dose intensity of XB010 [Tolerability] [Time frame: 24 Months]
  • Cohort-Expansion Stage: Maximum Plasma Concentration (Cmax) of XB010 [Time frame: 24 Months]
  • Cohort-Expansion Stage: Time to Maximum Plasma Concentration (Tmax) of XB010 [Time frame: 24 Months]
  • Cohort-Expansion Stage: Clearance of XB010 [Time frame: 24 Months]
  • Cohort-Expansion Stage: Area Under the Plasma Concentration Curve (AUC) of XB010 [Time frame: 24 Months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 16 centers
  • City of Hope Orange County Lennar Foundation Cancer Center — Irvine
  • UCLA Department of Medicine - Hematology/Oncology — Los Angeles
  • Georgetown University Medical Center — Washington D.C.
  • Sarah Cannon Research Institute at Florida Cancer Specialists — Orlando
  • Winship Cancer Institute — Atlanta
  • University of Chicago Medical Center — Chicago
  • Siteman Cancer Center — St Louis
  • Montefiore Medical Center - Montefiore Medical Park — The Bronx
  • … and 8 more centers
United Kingdom · 4 centers
  • University Hospitals of Leicester NHS Trust — Leicester
  • Sarah Cannon Research Institute London — London
  • University College London Hospitals NHS Foundation Trust — London
  • The Christie NHS Foundation Trust — Manchester

Identifiers

NCT: NCT06545331 · XB010-101 · 1012465

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗