Study of XB010 in Subjects With Solid Tumors

a study on Solid Tumor Squamous Cell Carcinoma Lung Cancer Non-Small Cell Lung Cancer Breast Cancer Hormone Receptor Positive Breast Cancer Triple-Negative Breast Cancer

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Irvine, California and other locations
Dates
study started
study ends around

Description

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.

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

Details

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.

Keywords

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), Esophageal Squamous Cell Carcinoma, Non-Small-Cell Lung Carcinoma, Triple Negative Breast Neoplasms, pembrolizumab

Eligibility

For people ages 18 years and up

  • 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.

Locations

  • Exelixis Clinical Site #4 accepting new patients
    Irvine California 92618 United States
  • Exelixis Clinical Site #6 accepting new patients
    Oklahoma City Oklahoma 73104 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Exelixis
Links
Sign up for this study
ID
NCT06545331
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 396 study participants
Last Updated
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