Actively Recruiting
A First-in-human (FIH), Phase I Study of PTX-912 in Patients with Locally Advanced/Metastatic Solid Tumors
Led by Proviva Therapeutics, Inc. · Updated on 2024-11-07
26
Participants Needed
3
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A First-in-human (FIH), Phase I Study of PTX-912 in Patients with Locally Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide signed informed consent and comply with study procedures
- Male and female patients aged 18 years or older
- Willing to follow all required visits, assessments, and procedures
- Diagnosed with locally advanced or metastatic solid tumors with disease progression after standard care or no clinical benefit from available treatments
- Recovery from prior therapy toxicities to acceptable baseline (Grade 0 or 1 except for non-safety risks like alopecia or vitiligo)
- Measurable disease according to RECIST v1.1 criteria
- ECOG performance status of 0 or 1 without deterioration during screening
- Adequate bone marrow and organ function based on lab results within 14 days before first dose
- Fully recovered from recent major surgery with no ongoing complications
- Willingness to follow study contraception requirements
- Life expectancy of at least 3 months as determined by the investigator
You will not qualify if you...
- Diagnosis of immunodeficiency
- Active infection needing systemic therapy within 4 weeks prior to study treatment
- History of intolerance, significant allergy, or anaphylaxis to PTX-912 or its components
- Unresolved toxicities from prior therapy above Grade 1 except alopecia, vitiligo, or Grade 2 neuropathy due to chemotherapy
- Significant immune-related toxicity from prior immunotherapy that precludes study treatment
- Major surgery within 30 days prior to first dose or planned major surgery during study
- Active autoimmune disease requiring systemic treatment in past 3 months or severe autoimmune disease needing steroids or immunosuppressants
- Uncontrolled diabetes or other uncontrolled immune-related endocrine conditions
- Primary central nervous system disease or leptomeningeal disease
- Impaired or significant cardiovascular disease
- Abnormal lung function or lung disease requiring steroids or oxygen therapy
- History of allogeneic bone marrow or solid organ transplant
- Receipt of live-virus vaccination within 14 days prior to first dose
- Significant bleeding within 2 weeks prior to first dose
- Pregnant or breastfeeding women or expecting to conceive during the study and 3 months after last dose
AI-Screening
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Trial Site Locations
Total: 3 locations
1
City of Hope National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
3
Nebraska Cancer Specialists (NCS)
Omaha, Nebraska, United States, 68130
Actively Recruiting
Research Team
P
Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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