PRL3-Zumab Phase 2 Trial, Advanced Solid Tumors, Multicenter

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Phase II Trial of PRL3-Zumab in Advanced Solid Tumor Patients

Phase 2 NCT07541001 Kind: PHASE2 Apr 21, 2026

Abstract

This is a multicenter, Phase II, open-label, single-dose level (6 mg/kg) study of PRL3-zumab monotherapy in patients with unresectable or metastatic solid tumors.

The study consists of a screening period (Day -21 to Day -1, during which all screening assessments must be completed prior to the first administration of study treatment), a treatment period (study visits every 2 weeks), an End-of-Treatment (EOT) visit (to beconducted within 14 days after discontinuation of treatment for any reason), a safety follow up visit (30 days after the last dose of study treatment), and survival follow-up (every 3 months after treatment discontinuation via telephone or other appropriate methods until the data cutoff date). PRL3-zumab will be administered via intravenous (i.v.) infusion until patients meet discontinuation criteria (clinically determined disease progression or disease progression confirmed according to RECIST v1.1 and iRECIST, intolerable toxicity, or withdrawal of consent). One treatment cycle is defined as 4 weeks (two infusions given 2 weeks apart).

Patients will undergo safety assessments, including laboratory tests, prior to each infusion within each cycle.

Tumor assessments will be performed at baseline according to RECIST v1.1 and iRECIST and every 8 weeks after initiation of study treatment. Quality of life (QoL) will be assessed at screening and every 8 weeks during treatment. Study treatment will be discontinued if patients develop clinically determined diseas...

Conditions: Advanced Malignant Solid Tumor

Interventions: PRL3-ZUMAB

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