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

NCT04452955 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 226688
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Solid Tumor

Keywords

PRL-3; Tumor; Efficacy; Safety; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  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.

  From first dose of study drug until disease progression or end of treatment, whichever comes first

Secondary Outcomes (11)

• Objective Response Rate (ORR)

  Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first.

• Clinical benefit rate (CBR)

  Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first

• Overall survival (OS)

  Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first

• Duration of response

  Time Frame: From first dose of study drug until disease progression or end of treatment, whichever comes first

• Terminal elimination half life (t½)

  Pre-dose and during first dose of C1, pre dose C1D15, C2D1, C2D15, C3D1, and pre dose and during the second dose of C3, pre-dose C4D1, C5D1, C6D1 and at end of treatment (up to approximately 6 months). Duration of 1 cycle is 4 weeks. C = Cycle, D = Day.

Study Arms (1)

PRL3-zumab

EXPERIMENTAL

All patients will receive PRL3-zumab until clinical progression per RECIST v1.1 and iRECIST criteria, or unacceptable toxicity, or withdraws consent.

Biological: PRL3-zumab

Interventions

PRL3-zumab BIOLOGICAL

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

PRL3-zumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Intra-IMMUSG Pte Ltd: lead
• Parexel: collaborator

Study Sites (5)

HonorHealth Research

Scottsdale, Arizona, 85258, United States

Location

St. Jude Medical Center

Fullerton, California, 92835, United States

Location

The Angeles Clinic

Los Angeles, California, 90025, United States

Location

Norton Healthcare

Louisville, Kentucky, 40200, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89014, United States

Location

Related Publications (1)

• Park DJ, Thura M, Chiu VK, Vicuna B, Ang KH, Sanchez B, Chia PL, Kuan KY, Li J, Zhang K, Zheng WH, Hsien Ng MC, Zeng Q. The PRL3-zumab paradigm: A multicenter, single-dose-level phase 2 basket clinical trial design of an unconventional cancer immunotherapy. Cell Rep Med. 2025 May 20;6(5):102120. doi: 10.1016/j.xcrm.2025.102120. Epub 2025 May 8.

  PMID: 40345181 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: July 1, 2020
• Study Start: December 12, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 22, 2026

Record last verified: 2025-11

Locations

US (5)