RECRUITING

A Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary purpose of the study is to characterize the safety and tolerability of XB371. The dose-escalation cohorts and Part B of the expansion cohorts are non-randomized. Part A of the expansion cohorts is randomized.

Official Title

A Dose Escalation and Expansion Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors

Quick Facts

Study Start:2025-08-11
Study Completion:2028-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07123103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  2. * Minimum life expectancy of ≥ 12 weeks.
  3. * Recurrent locally advanced or metastatic solid tumors.
  4. * Adequate end organ and bone marrow function.
  1. * Primary brain tumors or known active brain metastases, leptomeningeal, or cranial epidural disease.
  2. * History of interstitial lung disease (ILD) of any grade or history of organizing pneumonia.
  3. * Has acute ocular infection, acute or chronic ulcerative/cicatricial condition of conjunctiva or cornea.
  4. * Known history of immunodeficiency virus (HIV) unless specific criteria are met.
  5. * Active infection with hepatitis C virus (HCV) defined as positive for HCV antibody.
  6. * Major surgery within 4 weeks before the first dose of study treatment.
  7. * Received radiation therapy within 2 weeks before the first dose of study treatment.
  8. * Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study treatment.

Contacts and Locations

Study Contact

Exelixis Clinical Trials
CONTACT
1-888-EXELIXIS (888-393-5494)
druginfo@exelixis.com
Backup or International
CONTACT
1-650-837-7400

Study Locations (Sites)

Exelixis Clinical Site #1
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Exelixis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-11
Study Completion Date2028-02

Study Record Updates

Study Start Date2025-08-11
Study Completion Date2028-02

Terms related to this study

Keywords Provided by Researchers

  • Advanced Solid Tumors
  • Metastatic Solid Tumors

Additional Relevant MeSH Terms

  • Solid Tumors