New cancer drug trial halted after just 3 patients
NCT ID NCT07159828
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tested a new drug called AXN-2510 in adults with advanced solid tumors that had stopped responding to other treatments. The drug is a special antibody that targets two cancer pathways at once. However, the study was terminated early after enrolling only 3 participants, so we have very little information about its safety or effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AXN-2510 (a bispecific antibody that blocks PD-L1 and inhibits VEGF)
- What this could lead to
- If successful, this could point toward a new treatment option for advanced solid tumors that have not responded to other therapies.
- What could go wrong
- This was a very early, small Phase 1 trial that was terminated after only 3 participants. It is too early to know if the drug is safe or effective, and many early-stage cancer drugs never reach patients.
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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3 people
The number who actually took part.
- Started
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Sep 2025
- Finished
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Apr 2026
- 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
-
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.
Inclusion Criteria: * Confirmed diagnosis of an advanced or metastatic solid tumor that is relapsed or refractory following previous therapy, and for which there is no available standard therapy. * Availability of PD-L1 Tumor Proportion Score (TPS) or Combined Positive Score (CPS); OR willingness to submit tumor tissue, if available, for central testing. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. * Age ≥ 18 years at the time of signing the informed consent. * Adequate hepatic function. * Adequate renal function. * Adequate bone marrow function. * Adequate blood clotting function Exclusion Criteria: * Active, untreated brain metastases or leptomeningeal disease requiring immediate local therapy, with some exceptions. * Concurrent malignancy that is progressing or requires active treatment, with some exceptions. * Received prior treatment within 5 half-lives or 4 weeks prior to starting AXN-2510, whichever is shorter (6 weeks for nitrosourea or mitomycin-C). Patients with prostate or breast cancer may continue concurrent hormone therapy. * Current use of immune-suppressive medication at the time of study enrollment, with some exceptions. * Uncontrolled hypertension defined as blood pressure of ≥ 160 mmHg systolic and/or ≥ 95 mmHg diastolic. * Gross hemoptysis within 2 months of enrollment (defined as coughing up ≥ 0.5 teaspoons of fresh blood or small blood clots). * Concurrent use of therapeutic anticoagulation or anti-platelet agents. * History of perforation and/or fistula of the gastrointestinal tract, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), acute gastrointestinal bleeding within 6 months before enrollment, or extensive bowel resection within 6 months prior to enrollment. * History of stroke, transient ischemic attack, or clinically significant thromboembolic event within 6 months prior to enrollment. * Tumors with radiographic evidence of blood vessel invasion, central necrosis or intratumor cavitation, encasement of organs (e.g. heart, trachea, esophagus, central bronchi) or major blood vessels (e.g. central pulmonary artery, central pulmonary veins, aorta, brachiocephalic artery, common carotid artery, subclavian artery, superior vena cava). * Impaired cardiac function or significant diseases. * History of pulmonary fibrosis or interstitial pneumonia, pneumoconiosis, chemical pneumonia, interstitial lung disease requiring steroids, or other diseases causing severe impairment of lung function. * Unresolved toxicity higher than Grade 1 CTCAE v5 (or most current version) attributed to any prior therapy or procedure at Screening, with exceptions for alopecia or Grade 2 neuropathy. * Any prior Grade 4 immune-mediated adverse event (imAE) or Grade 3 imAE requiring steroid treatment while receiving immunotherapy that has been documented within the 12 months prior to the enrollment period. * Known human immunodeficiency virus (HIV) or acquired immune deficiency syndromes. Note: well-controlled HIV will be allowed. * Positive hepatitis B surface antigen and/or hepatitis B core antibody (participants with negative polymerase chain reaction assay are permitted with appropriate antiviral therapy). If a hepatitis test was conducted and had a negative result within 30 days of enrollment, an additional test is not required at screening. * Active hepatitis C infection with positive viral loads. Participants who have been treated for hepatitis C infection can be included if they have documented sustained virologic response of ≥ 12 weeks. If a hepatitis test was conducted and had a negative result within 30 days of enrollment, an additional test is not required at screening. * Known history of any grade hypersensitivity reactions (despite appropriate premedication) to any known components of AXN-2510 or required premedication. * Women who are pregnant or lactating. * Has a history or current evidence of any condition, therapy, or laboratory abnormality that in the opinion of the investigator, might confound the results of the trial.
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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.
Contacts and locations
Locations
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Carolina BioOncology
Huntersville, North Carolina, 28078, United States
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NEXT Houston
Houston, Texas, 77054, United States
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NEXT San Antonio
San Antonio, Texas, 78229, United States
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NEXT Virginia
Fairfax, Virginia, 22031, United States
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New Experimental Therapeutics (NEXT) Oncology - Houston
Houston, Texas, 77054, United States
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New Experimental Therapeutics of San Antonio - NEXT Oncology
San Antonio, Texas, 78229, United States
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Sarah Cannon Research Institute at Mary Crowley
Dallas, Texas, 75251, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- 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