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New drug XB010 takes on advanced cancers in first human trial

NCT ID NCT06545331

Disease control Sponsor: Exelixis Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This early study tests an experimental drug called XB010, alone or combined with the immunotherapy pembrolizumab, in people with advanced solid tumors (like lung, breast, or head and neck cancers) that have stopped responding to other treatments. The main goals are to find a safe dose and check for any signs that the tumors shrink. About 396 adults will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
XB010 (an experimental drug) and pembrolizumab (an immunotherapy drug)
What this could lead to
If successful, this could point toward a new treatment option for people with advanced solid tumors who have run out of standard therapies.
What could go wrong
This is a very early Phase 1 trial, so the drug may not work or may have unexpected side effects. It is also small and not designed to prove effectiveness yet.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 396 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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.

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Conditions

The condition(s) this trial relates to.

esophageal squamous cell carcinoma head and neck squamous cell carcinoma hormone receptor-positive breast cancer non-small cell lung carcinoma triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Esophageal squamous cell cancer Head and neck squamous cell cancer Hormone receptor-positive breast cancer Locally advanced or metastatic solid tumors NSCLC (non-small cell lung cancer) Triple negative breast cancer (TNBC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    20 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Baylor University Medical Center

    RECRUITING

    Dallas, Texas, 75246, United States

  • Carolina BioOncology Institute

    RECRUITING

    Huntersville, North Carolina, 28078, United States

  • City of Hope Orange County Lennar Foundation Cancer Center

    RECRUITING

    Irvine, California, 91010, United States

  • Georgetown University Medical Center

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Inova Schar Cancer

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Montefiore Medical Center - Montefiore Medical Park

    RECRUITING

    The Bronx, New York, 10461, United States

  • NEXT Austin

    RECRUITING

    Austin, Texas, 78758, United States

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Sarah Cannon Research Institute London

    RECRUITING

    London, W1G 6AD, United Kingdom

  • Sarah Cannon Research Institute at Florida Cancer Specialists

    RECRUITING

    Orlando, Florida, 32827, United States

  • Siteman Cancer Center

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Stephenson Cancer Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • The Christie NHS Foundation Trust

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • UCLA Department of Medicine - Hematology/Oncology

    RECRUITING

    Los Angeles, California, 90095, United States

  • University College London Hospitals NHS Foundation Trust

    RECRUITING

    London, W1T 7HA, United Kingdom

  • University Hospitals of Leicester NHS Trust

    RECRUITING

    Leicester, LE1 5WW, United Kingdom

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Winship Cancer Institute

    RECRUITING

    Atlanta, Georgia, 30322, United States

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