NCT04452955

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

An Open Label, Multicenter, Safety and Efficacy Phase 2 Study of PRL3-Zumab in Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Intra-IMMUSG Pte Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Solid Tumor

Interventions

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

Timeline

• Start date: 2020-12-12
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2020-07-01
• Last updated: 2025-12-02

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study