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

Launched by EXELIXIS · Apr 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called XB628, which is being tested for people with advanced or spreading solid tumors that have come back after previous treatments. XB628 is a type of drug that helps the immune system fight cancer by targeting specific proteins on cancer cells and immune cells. This study is in its early phase, meaning it’s the first time this treatment is being tested in people to see if it is safe and how well it works.

To participate in the trial, individuals need to be between the ages of 65 and 74, have a confirmed diagnosis of a recurrent advanced or metastatic solid tumor, and be in reasonably good health. They should also have already tried at least one other cancer treatment. Participants will receive the study treatment and will be closely monitored for any effects, both good and bad. It’s important to note that people with certain conditions, like active brain tumors or recent major surgeries, may not be eligible for this trial. Overall, this study aims to explore a new approach to treating difficult-to-manage cancers, and participants will help researchers understand how well this treatment works.

Gender

ALL

Eligibility 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.