Overview

The goal of this clinical trial is to learn more about the side effects and best dose of AXN-2510 in adults with advanced solid tumors. The main questions it aims to answer are:

• 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.

Eligibility

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.
• 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.