PTX-35 in Patients With Advanced Solid Tumors (NCT04430348) | Clinical Trial Compass
TerminatedPhase 1
PTX-35 in Patients With Advanced Solid Tumors
Stopped: Absence of immunological response
United States22 participantsStarted 2020-06-04
Plain-language summary
A Phase I, First-in-Human, Dose-Escalation Study to Evaluate the Safety of the Monoclonal Antibody PTX-35 in Patients with Advanced Solid Tumors Refractory to Standard of Care
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Be willing and have the capacity to sign the written informed consent form.
✓. Be male or female of at least 18 years of age at the time of signing informed consent.
✓. Have a documented diagnosis of metastatic or advanced, unresectable solid tumor disease. Patient must have progressed or recurred following standard of care (SOC) therapies, or are ineligible for, or who refuse other safe and effective SOC therapies, and whom the Investigator believes may benefit from experimental treatment with PTX-35.
✓. Have an acceptable organ function, as defined below:
✓. Albumin ≥ 2.5 g/dL
✓. Total bilirubin \< 3.0 × upper limit of normal (ULN), unless patient has Gilbert's syndrome
✓. Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3.0 × ULN, or
✓. Calculated or measured creatinine clearance \> 35 mL/minute per the Cockcroft-Gault formula
Exclusion criteria
✕. Have received any systemic anticancer therapy including small molecules, chemotherapy, radiation therapy, monoclonal antibodies or any other experimental drug within 4 weeks of first dose of PTX-35. Adjuvant anti hormonal treatment(s) for prior breast cancer or prostate cancer are allowed. (Note: washout for palliative radiation therapy is 2 weeks).
✕. Have clinically significant cardiac disease, including:
✕
What they're measuring
1
Subjects With Any Treatment-emergent Adverse Events (TEAEs) During the Trial
. Onset of unstable angina within 6 months of signing the Informed Consent Form (ICF).
✕. Acute myocardial infarction within 6 months of the signing the ICF.
✕. Known congestive heart failure (Grade III or IV as classified by the New York Heart Association); and/ or a known decreased cardiac ejection fraction (LVEF) of \< 45%.
✕. Uncontrolled hypertension defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥ 100 mmHg, despite optimal medical management.
✕. Have known or clinically suspected leptomeningeal disease. Stable, previously treated metastases in the brain or spinal cord, are allowed as long as these are considered stable (by CT or MRI), and not requiring systemic corticosteroids.
✕. Have a history of ≥ Grade 3 allergic reactions, or suspected allergy or intolerance to monoclonal antibody therapies.