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Active (not recruiting) Phase 2 NCT04452955

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

Phase 2 – studying effectiveness and dosage
Conditions: Solid Tumor

Sponsor: Intra-IMMUSG Pte Ltd

trial.available_in: БГ
Overview
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.
Description
The study consists of a Screening Period (Day - 14 to Day -1), a Treatment Period during which visits will occur every 2 weeks, an End of Treatment visit within 14 days of the decision to discontinue treatment for any reason, and a Safety Follow-up visit at 14 ± 4 days after the last dose of study treatment. PRL3-zumab will be administered by intravenous (IV) infusion till patient meets any of the discontinuation criteria (progressive disease, clinically or per RECIST v1.1 and iRECIST, intolerable toxicity or withdrawal of consent). One cycle of treatment will be 4 weeks (2 infusions, 12 days ±2 days apart).
Who can participate
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
Interventions
PRL3-zumab
BIOLOGICAL
Locations 5
United States (5)
St. Jude Medical Center
Fullerton , California
Comprehensive Cancer Centers of Nevada
Las Vegas , Nevada
The Angeles Clinic
Los Angeles , California
Norton Healthcare
Louisville , Kentucky
HonorHealth Research
Scottsdale , Arizona
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
12.12.2020
Completion date
01.12.2026
Registry ID
NCT04452955
Source
clinicaltrials.gov
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