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RecruitingPhase 1

Study of XB010 in Subjects With Solid Tumors

A Dose-Escalation and Expansion Study of XB010 as a Single Agent and Combination Therapy in Subjects With Locally Advanced or Metastatic Solid Tumors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This first study in people tests XB010 alone and with pembrolizumab in adults with solid tumors that have grown nearby or spread. It checks safety, side effects, how the body handles XB010, how the immune system reacts, and whether it may fight cancer. It is for people who have no other treatment options, cannot tolerate available treatments, or whose treatments no longer work.

This is a FIH study is to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of XB010 as a single agent and in combination with pembrolizumab in subjects with locally advanced or metastatic solid tumors for whom alternative therapies do not exist or available therapies are intolerable or no longer effective.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older when you agree to join.
  • Be fully active or able to do light work, even if heavy activity is limited.
  • Have organs and bone marrow that work well enough. Bone marrow makes blood cells.
  • Have a solid tumor confirmed by cell or tissue tests and scans. It must be unable to be removed by surgery, have grown nearby, have spread, or have come back.
  • For the study's expansion stage, have one of these cancers: non-small cell lung cancer, hormone-receptor-positive breast cancer, head and neck cancer, esophageal squamous cell cancer (a type of food pipe cancer), or triple-negative breast cancer.
  • Be able to understand and follow the study rules and sign a form agreeing to join.

Who can't join

    Simplified for readability. The official criteria below are what the study team uses.

    Official eligibility criteria

    * Age 18 years or older on the day of consent. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1. * Adequate organ and marrow function. * Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent. * The Cohort Expansion stage will enroll subjects with multiple tumor types (non-small cell lung cancer, hormone-receptor-positive breast cancer, head and neck cancer, esophageal squamous cell, triple-negative breast cancer). * Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.

    Study sites (16)

    CA

    DC

    FL

    GA

    IL

    MO

    NC

    NY

    OK

    TN

    TX

    VA