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
Proviva Therapeutics, Inc.
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 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. 2. Male and Female patients age ≥ 18 years on day of signing informed consent. 3. Willing to comply with all protocol-required visits, assessments, and procedures. 4. 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. 5. Recovery from all toxicities associat…
Interventions
- DrugPTX-912
Investigation Product Monotherapy
Locations (3)
- City of Hope National Medical CenterDuarte, California
- University of MiamiMiami, Florida
- Nebraska Cancer Specialists (NCS)Omaha, Nebraska