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Active, not recruiting Phase 2

A Study to Assess Safety and Efficacy of PRL3-Zumab in Patients With Solid Tumors

NCT04452955 · tracked via the Priya Life Science USA tracker
Phase
Phase 2
Started
2020-12-12
Last updated
2026-04-22

Condition(s) studied

Solid Tumor

Investigational drug(s) / intervention(s)

PRL3-zumab →

PRL3-zumab: Starting dose of 6 mg/kg will be administered as IV infusion over 60 minutes every 2 weeks (±2 days)

Study summary

This is a multi-center, Phase 2, open-label, single dose level study of PRL3-zumab monotherapy in patients with unresectable or metastatic solid tumor.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients with unresectable or metastatic solid tumors willing to provide signed informed consent. * Histopathological diagnosis and metastatic status cancer at study entry. * Must have received at least 1 prior line of systemic therapy for metastatic disease but no more than 3 prior lines of treatment for metastatic disease. * Life expectancy of more than 6 months. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) score or less than 2. * Adequate organ and hematological function. * Measurable disease by RECIST v1.1 and iRECIST. Exclusion Criteria: * Patient has known untreated or symptomatic central nervous system metastasis. * Patient is receiving systemic glucocorticoids or other immunosuppressive treatments for autoimmune disease or any other medical condition. * Patient has experienced a severe hypersensitivity reaction to another monoclonal antibody. * Patient has received treatment with any systemic anti-cancer therapies within 3 weeks prior to starting study treatment. * Patient has undergone radiotherapy ≤ 4 weeks prior to starting study treatment. * Patient has received \> 3 lines of prior systemic chemotherapy for metastatic disease

Primary outcome measure(s)

  • Progression free survival (PFS) — From first dose of study drug until disease progression or end of treatment, whichever comes first
    PFS is defined as the time from the initiation of study treatment to the date of disease progression as per RECIST v1.1 and iRECIST criteria.

Trial sites (5)

FacilityCityRegionStatus
HonorHealth Research Scottsdale Arizona
St. Jude Medical Center Fullerton California
The Angeles Clinic Los Angeles California
Norton Healthcare Louisville Kentucky
Comprehensive Cancer Centers of Nevada Las Vegas Nevada
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04452955 on ClinicalTrials.gov ↗ ← All trials in the USA