Testing XB628 for advanced or metastatic solid tumors
A Phase 1 Study of XB628 in Participants With Recurrent Advanced or Metastatic Solid Tumors
PHASE1 · Exelixis · NCT06952010
This study is testing a new treatment called XB628 to see if it can help people with advanced or metastatic solid tumors by finding the right dose that is safe and effective.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Exelixis (industry) |
| Drugs / interventions | monalizumab, radiation |
| Locations | 10 sites (San Francisco, California and 9 other locations) |
| Trial ID | NCT06952010 on ClinicalTrials.gov |
What this trial studies
This phase 1, first-in-human, open-label, dose-escalation study evaluates XB628, a bispecific antibody designed to engage natural killer (NK) cells by targeting NKG2A and PD-L1. The study aims to determine the maximum tolerated dose (MTD) and recommended dosage(s) for expansion of XB628 as a single agent in participants with recurrent advanced or metastatic solid tumors. Participants will receive escalating doses of XB628 to assess safety and efficacy.
Who should consider this trial
Good fit: Ideal candidates are adults with recurrent advanced or metastatic solid tumors who have received prior systemic anticancer therapy.
Not a fit: Patients with primary brain tumors or known active brain metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat advanced or metastatic solid tumors.
How similar studies have performed: Other studies involving bispecific antibodies and NK cell engagement have shown promise, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Minimum life expectancy of ≥ 12 weeks. * Have a recurrent advanced or metastatic solid tumor that is histologically or cytologically confirmed. * Adequate organ and marrow function. * Not amenable to curative treatment with surgery or radiation. * Received at least 1 line of prior systemic anticancer therapy in the recurrent or metastatic setting. * Acceptable alternative therapy was received, refused, intolerable, or no longer effective. * Capable of understanding and complying with the protocol requirements and provide signed informed consent according to the protocol and local requirements. Exclusion Criteria * Primary brain tumors or known active brain metastases. * Major surgery (eg, gastrointestinal surgery, removal or biopsy of brain metastasis) within 4 weeks before the first dose of study treatment. * Received radiation therapy within 1 week before the first dose of study treatment or clinically relevant ongoing complications from prior radiation therapy. * Received prior therapy targeting NK cells (eg, monalizumab). * A woman of childbearing potential has a positive serum pregnancy test within 7 days prior to study treatment.
Where this trial is running
San Francisco, California and 9 other locations
- Exelixis Site #5 — San Francisco, California, United States (RECRUITING)
- Exelixis Site #4 — New Haven, Connecticut, United States (RECRUITING)
- Exelixis Clinical Site #8 — Tampa, Florida, United States (RECRUITING)
- Exelixis Clinical Site #10 — Boston, Massachusetts, United States (RECRUITING)
- Exelixis Site #6 — St Louis, Missouri, United States (RECRUITING)
- Exelixis Site #7 — New York, New York, United States (RECRUITING)
- Exelixis Clinical Site #1 — Hickory, North Carolina, United States (RECRUITING)
- Exelixis Clinical Site #3 — Nashville, Tennessee, United States (RECRUITING)
- Exelixis Clinical Site #9 — Houston, Texas, United States (RECRUITING)
- Exelixis Clinical Site #2 — San Antonio, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Exelixis Clinical Trials
- Email: druginfo@exelixis.com
- Phone: 1-888-EXELIXIS (888-393-5494)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Solid Tumor, Advanced Solid Tumor, Metastatic Solid Tumor, Immune Sensitive Tumor, XB628, Solid tumor, Advanced solid tumor, Metastatic solid tumor