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New hope for Hard-to-Treat cancers? early trial launches

NCT ID NCT06952010

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial is testing a new biologic drug called XB628, alone or with an oral drug called zanzalintinib, in people with advanced or metastatic solid tumors that have not responded to prior treatments. The study has two parts: first, finding a safe dose, and then checking if the drugs can shrink tumors. About 303 participants 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
XB628 (a biologic given by IV) and zanzalintinib (an oral drug)
What this could lead to
If it works, this could point toward a new treatment option for people with advanced solid tumors that have not responded to other therapies.
What could go wrong
This is a very early Phase 1 trial, so the main goals are safety and dosing—not yet proving the drug works. Many early-stage cancer drugs fail to show enough benefit to move forward.

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 303 people

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

Started

May 2025

Expected to finish

Nov 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.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

    11 sites. 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

  • Exelixis Clinical Site #1

    RECRUITING

    Hickory, North Carolina, 28602, United States

  • Exelixis Clinical Site #10

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Exelixis Clinical Site #11

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Exelixis Clinical Site #2

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Exelixis Clinical Site #3

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Exelixis Clinical Site #4

    RECRUITING

    New Haven, Connecticut, 06520, United States

  • Exelixis Clinical Site #5

    RECRUITING

    San Francisco, California, 94158, United States

  • Exelixis Clinical Site #6

    RECRUITING

    St Louis, Missouri, 63108, United States

  • Exelixis Clinical Site #7

    RECRUITING

    New York, New York, 10029, United States

  • Exelixis Clinical Site #8

    RECRUITING

    Tampa, Florida, 33612, United States

  • Exelixis Clinical Site #9

    RECRUITING

    Houston, Texas, 77030, United States

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