RECRUITING

A Study of XB628 in Participants With Recurrent Advanced or Metastatic Solid Tumors

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Conditions

Solid TumorAdvanced Solid TumorMetastatic Solid TumorImmune Sensitive TumorXB628PD-L1

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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

This is a phase 1, first-in-human, open-label, dose-escalation study of XB628, a first-in-class bispecific antibody natural killer (NK) cell engager that targets NK group 2 member A (NKG2A), an inhibitory receptor on NK cells, and programmed cell death-ligand 1 (PD-L1).

Official Title

A Phase 1 Study of XB628 in Participants With Recurrent Advanced or Metastatic Solid Tumors

Quick Facts

Study Start:2025-05
Study Completion:2027-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06952010

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. * Have a recurrent advanced or metastatic solid tumor that is histologically or cytologically confirmed.
  4. * Adequate organ and marrow function.
  5. * Not amenable to curative treatment with surgery or radiation.
  6. * Received at least 1 line of prior systemic anticancer therapy in the recurrent or metastatic setting.
  7. * Acceptable alternative therapy was received, refused, intolerable, or no longer effective.
  8. * Capable of understanding and complying with the protocol requirements and provide signed informed consent according to the protocol and local requirements.
  9. * Primary brain tumors or known active brain metastases.
  10. * Major surgery (eg, gastrointestinal surgery, removal or biopsy of brain metastasis) within 4 weeks before the first dose of study treatment.
  11. * Received radiation therapy within 1 week before the first dose of study treatment or clinically relevant ongoing complications from prior radiation therapy.
  12. * Received prior therapy targeting NK cells (eg, monalizumab).
  13. * A woman of childbearing potential has a positive serum pregnancy test within 7 days prior to study treatment.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Exelixis Clinical Site #1
Hickory, North Carolina, 28602
United States
Exelixis Clinical Site #2
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 Date2025-05
Study Completion Date2027-11

Study Record Updates

Study Start Date2025-05
Study Completion Date2027-11

Terms related to this study

Keywords Provided by Researchers

  • XB628
  • Solid tumor
  • Advanced solid tumor
  • Metastatic solid tumor
  • Immune sensitive tumor
  • PD-L1

Additional Relevant MeSH Terms

  • Solid Tumor
  • Advanced Solid Tumor
  • Metastatic Solid Tumor
  • Immune Sensitive Tumor