A Study to Assess AXN-2510 Treatment in Adult Patients With Advanced Solid Tumors

Inclusion Criteria:

• Confirmed diagnosis of an advanced or metastatic solid tumor that is relapsed orrefractory following previous therapy, and for which there is no available standardtherapy.

• 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 immediatelocal therapy, with some exceptions.

• Concurrent malignancy that is progressing or requires active treatment, with someexceptions.

• 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 withprostate or breast cancer may continue concurrent hormone therapy.

• Current use of immune-suppressive medication at the time of study enrollment, withsome 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 ≥ 0.5teaspoons 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 ofgastrointestinal obstruction (including incomplete intestinal obstruction requiringparenteral nutrition), acute gastrointestinal bleeding within 6 months beforeenrollment, or extensive bowel resection within 6 months prior to enrollment.

• History of stroke, transient ischemic attack, or clinically significantthromboembolic event within 6 months prior to enrollment.

• Tumors with radiographic evidence of blood vessel invasion, central necrosis orintratumor cavitation, encasement of organs (e.g. heart, trachea, esophagus, centralbronchi) or major blood vessels (e.g. central pulmonary artery, central pulmonaryveins, 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, chemicalpneumonia, interstitial lung disease requiring steroids, or other diseases causingsevere 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 foralopecia or Grade 2 neuropathy.

• Any prior Grade 4 immune-mediated adverse event (imAE) or Grade 3 imAE requiringsteroid 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 (participantswith negative polymerase chain reaction assay are permitted with appropriateantiviral therapy). If a hepatitis test was conducted and had a negative resultwithin 30 days of enrollment, an additional test is not required at screening.

• Active hepatitis C infection with positive viral loads. Participants who have beentreated for hepatitis C infection can be included if they have documented sustainedvirologic response of ≥ 12 weeks. If a hepatitis test was conducted and had anegative result within 30 days of enrollment, an additional test is not required atscreening.

• Known history of any grade hypersensitivity reactions (despite appropriatepremedication) 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 laboratoryabnormality that in the opinion of the investigator, might confound the results ofthe trial.