A First-in-human (FIH), Phase I Study of PTX-912 in Patients with Locally Advanced/Metastatic Solid Tumors (NCT06190886)
🩺 Plain-English Summary (8th-Grade Level)
The goal of this clinical trial is to evaluate the safety and tolerability of escalating doses of PTX-912 in patients with locally advanced or metastatic solid tumors. To evaluate the PK and immunogenicity profile of PTX-912. To evaluate the preliminary anti-tumor activity of PTX-912. Participants will be treated with PTX-912 via iv infusion, every 2 weeks until progression of disease, unacceptable toxicity, or 12 months of total study therapy.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (16 items).
Location: City of Hope National Medical Center — Duarte, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Has a diagnosis of immunodeficiency.
- Has an active infection requiring systemic therapy within 4 weeks prior to study treatment.
- History of or known intolerance, significant hypersensitivity, or anaphylaxis to any components of PTX-912 or any of the excipients.
- Unresolved toxicities from prior systemic therapy greater than NCI CTCAE grade 1 at time of first dose, except alopecia, vitiligo, and grade 2 neuropathy due to prior chemotherapy.
- Experienced clinically significant immune-related toxicity from prior immunotherapy that in the opinion of the investigator would preclude protocol therapy or would make the patient inappropriate for the study.
- Major surgery within 30 days prior to first dose of study drug (with the below exceptions), or anticipation of major surgery during study treatment.
- Active autoimmune disease requiring systemic treatment within the past 3 months or have a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive agents.
- Uncontrolled diabetes mellitus or other uncontrolled immune-related endocrinopathies in the opinion of the investigator.
- Primary central nervous system (CNS) disease or leptomeningeal disease.
- Impaired cardiovascular function or clinically significant cardiovascular disease.
- Abnormal pulmonary function within the previous 6 months, including history of pneumonitis, active pneumonitis, interstitial lung disease requiring the use of steroids, idiopathic pulmonary fibrosis, active pleural effusion, severe dyspnea at rest or requiring supplementary oxygen therapy.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (3 Sites)
- City of Hope National Medical Center — Duarte, California
- University of Miami — Miami, Florida
- Nebraska Cancer Specialists (NCS) — Omaha, Nebraska
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.