A Study to Assess AXN-2510 Treatment in Adult Patients With Advanced Solid Tumors
NCT ID: NCT07159828
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
52 participants
INTERVENTIONAL
2025-09-15
2027-05-15
Brief Summary
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* What are the side effects of AXN-2510?
* Which is the best tolerated dose of AXN-2510?
* How long does AXN-2510 stay in your body?
Participants will receive AXN-2510 every 3 weeks. Participants will visit the clinic for checkups and tests several days during the first and third doses, and once every 3 weeks for other doses.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AXN-2510
AXN-2510 given as intravenous (IV) infusion every 3 weeks, for a maximum of 24 months of treatment or until discontinuation criteria is met. Two increasing dose levels will be tested.
AXN-2510
AXN-2510 is an antibody with PD-L1 blocking and VEGF inhibition activity in one drug. This is called a bispecific antibody, because it has 2 activities. This immuno-oncology treatment is in development for the treatment of solid tumors. AXN-2510 is differentiated from other PD-L1 and VEGF bispecific antibodies by its ability to inhibit multiple VEGF molecules and also increased antibody-dependent cellular cytotoxicity (ADCC) that can directly kill PD-L1-positive tumor cells.
Interventions
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AXN-2510
AXN-2510 is an antibody with PD-L1 blocking and VEGF inhibition activity in one drug. This is called a bispecific antibody, because it has 2 activities. This immuno-oncology treatment is in development for the treatment of solid tumors. AXN-2510 is differentiated from other PD-L1 and VEGF bispecific antibodies by its ability to inhibit multiple VEGF molecules and also increased antibody-dependent cellular cytotoxicity (ADCC) that can directly kill PD-L1-positive tumor cells.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
* Active or clinically significant bleeding within 6 months for major bleeding or within 4 weeks for minor bleeding prior to Screening.
* History of stroke, transient ischemic attack, or clinically significant thromboembolic event within 6 months prior to enrollment.
* Radiographic evidence of tumor invasion into major blood vessels (e.g., pulmonary artery, carotid artery) or tumors with central necrosis or cavitation.
* 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).
* 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.
* 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.
18 Years
ALL
No
Sponsors
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Axion Bio, Inc
INDUSTRY
Instil Bio
INDUSTRY
Responsible Party
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Principal Investigators
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Jill I Loftiss, RN
Role: STUDY_DIRECTOR
Instil Bio
Locations
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Carolina BioOncology
Huntersville, North Carolina, United States
Sarah Cannon Research Institute at Mary Crowley
Dallas, Texas, United States
New Experimental Therapeutics (NEXT) Oncology - Houston
Houston, Texas, United States
NEXT Houston
Houston, Texas, United States
New Experimental Therapeutics of San Antonio - NEXT Oncology
San Antonio, Texas, United States
NEXT San Antonio
San Antonio, Texas, United States
NEXT Virginia
Fairfax, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Neel Gandhi
Role: primary
Douglas Orr
Role: primary
Jennifer Segar
Role: primary
David Sommerhalder
Role: primary
Neel Balani
Role: primary
Other Identifiers
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AXN2510X2101
Identifier Type: -
Identifier Source: org_study_id