Testing XB628 for advanced or metastatic solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Key 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.

Key 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where it's running

• Exelixis Clinical Site #5
  San Francisco, California, United States Recruiting
• Exelixis Clinical 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 Clinical Site #11
  Boston, Massachusetts, United States Recruiting
• Exelixis Clinical Site #6
  St Louis, Missouri, United States Recruiting

Study contacts

• Study coordinator: Exelixis Clinical Trials
• Email: druginfo@exelixis.com
• Phone: 1-888-EXELIXIS (888-393-5494)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.