Actively Recruiting
A First-in-human (FIH), Multicenter, Open-Label, Phase Ia (Dose Escalation)/Phase Ib (Dose Expansion) 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
10 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of increasing doses of PTX-912 in patients with locally advanced or metastatic solid tumors who have had disease progression after standard treatments or have no beneficial standard care options. The study also aims to assess how the body processes PTX-912 and its immune response profile, along with preliminary anti-tumor activity. This is a first-in-human, phase I trial led by Proviva Therapeutics, Inc. Participants will receive PTX-912 through intravenous infusion every two weeks. Treatment will continue until the disease progresses, unacceptable side effects occur, or a total of 12 months of therapy is completed. The study uses a dose escalation design where patients receive single or multiple ascending doses of PTX-912. During the trial, participants will undergo regular visits for assessments including blood tests to monitor bone marrow and organ function, scans to measure tumor response, and evaluations of side effects. Researchers will particularly track dose limiting toxicities within the first 28 days. Participants must be able to comply with study visits and procedures, and their health status will be closely monitored throughout the treatment period, which may last up to one year.
CONDITIONS
Brief 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 and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures.
- Male and Female patients age 65 18 years on day of signing informed consent.
- Willing to comply with all protocol-required visits, assessments, and procedures.
- Patients with locally advanced or metastatic solid tumors who have had disease progression on all available standard of care or for whom no reasonable standard of care exists that would confer clinical benefit.
- Recovery from all toxicities associated with prior therapy to acceptable baseline status (for laboratory toxicities, see limits for inclusion). NCI CTCAE v5.0 Grade 0 or 1, except for toxicities not considered a safety risk (e.g., alopecia or vitiligo).
- Measurable disease per RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with no deterioration during Screening.
- Adequate bone marrow and organ function, defined by the following laboratory results obtained within 14 days before first dose of study drug.
- Patients with recent major surgery must have adequately recovered with no ongoing complications from the surgery prior to receiving study treatment.
- Willingness to adhere to the study treatment-specific contraception requirements.
- Estimated life expectancy of 3 months (12 weeks) or greater as determined by Investigator.
You will not qualify if you...
- 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.
- History of allogenic, bone marrow, or solid organ transplants.
- Received a live-virus vaccination 6414 days prior to first dose of study drug (seasonal flu and other inactivated vaccines that do not contain live virus are permitted).
- Clinically significant bleeding within 2 weeks prior to first dose of study drug dy.
- Pregnant or breast-feeding women or expecting to conceive within the projected duration of the trial, starting with the screening visit through 3 months after the last dose of study drug.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 28 days per dose escalation cycle
Participants receive single or multiple ascending doses of PTX-912 as part of the study drug treatment.
Multiple visits during dosing and monitoring
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
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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