Clinical Trials in the USA / NCT04452955
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
Condition(s) studied
Solid Tumor
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
Other trials for the same condition
SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors
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Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion
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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