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New hope for Hard-to-Treat cancers? early trial launches
NCT ID NCT06952010
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 303 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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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Get notified about this study
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Genom att skicka in godkänner du våra Användarvillkor
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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
11 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Exelixis Clinical Site #1
RECRUITINGHickory, North Carolina, 28602, United States
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Exelixis Clinical Site #10
RECRUITINGBoston, Massachusetts, 02114, United States
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Exelixis Clinical Site #11
RECRUITINGBoston, Massachusetts, 02114, United States
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Exelixis Clinical Site #2
RECRUITINGSan Antonio, Texas, 78229, United States
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Exelixis Clinical Site #3
RECRUITINGNashville, Tennessee, 37203, United States
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Exelixis Clinical Site #4
RECRUITINGNew Haven, Connecticut, 06520, United States
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Exelixis Clinical Site #5
RECRUITINGSan Francisco, California, 94158, United States
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Exelixis Clinical Site #6
RECRUITINGSt Louis, Missouri, 63108, United States
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Exelixis Clinical Site #7
RECRUITINGNew York, New York, 10029, United States
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Exelixis Clinical Site #8
RECRUITINGTampa, Florida, 33612, United States
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Exelixis Clinical Site #9
RECRUITINGHouston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First human test of BI 4060107 aims to find safe dose for Hard-to-Treat tumors
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Can a new drug shield kidneys from chemotherapy damage?
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers