New drug combo takes on tough tumors
NCT ID NCT06462794
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 3 times
Summary
This early-stage trial is testing an investigational drug called CX-801, alone or with the immunotherapy Keytruda, in 121 adults with advanced solid tumors that have not responded to standard treatments. The main goals are to check safety and find the right dose. Researchers will also look for signs that the tumors shrink.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CX-801 (an investigational drug) and pembrolizumab (Keytruda)
- What this could lead to
- If it works, this could point toward a new treatment option for advanced solid tumors that have stopped responding to standard therapies.
- What could go wrong
- This is a very early (Phase 1) trial with only 121 people, so it is primarily testing safety and dosing. The drug may not shrink tumors or may cause side effects.
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 121 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Jun 2029
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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Metastatic or locally advanced unresectable solid tumor that has progressed after standard therapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Measurable disease per RECIST v1.1 * Consent to fresh biopsy or if medically contraindicated, recent (within 6 months) archival tumor tissue * Adequate organ function * Additional inclusion criteria may apply Exclusion Criteria: * Recent history (within last 2 years) of localized cancers that are not related to the current cancer being treated * Known active central nervous system (CNS) involvement by malignancy * Prior PD-1/ PD-(L)1 inhibitor treatment discontinued due to grade 3 or higher immune related adverse event * Systemic anticancer treatment within 4 weeks or 5 half lives prior to first dose of study treatment * Investigational drug or device within 4 weeks prior to first dose of study treatment * Radiation within 2 weeks prior to first dose of study treatment * Serious concurrent illness * Pregnant or breast feeding * Additional 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
5 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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SCRI Oncology Partners
RECRUITINGNashville, Tennessee, 37203, United States
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START Dallas Fort Worth, LLC
RECRUITINGFort Worth, Texas, 76104, United States
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The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate
RECRUITINGLos Angeles, California, 90025, United States
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The Melanoma and Skin Cancer Institute
RECRUITINGEnglewood, Colorado, 80113, United States
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University of Pittsburgh Hillman Cancer Center
RECRUITINGPittsburgh, Pennsylvania, 15232, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- 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
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Mining Responders' tumors for clues to a universal cancer therapy