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RECRUITING
NCT07290088
PHASE2/PHASE3

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

Sponsor: Intra-IMMUSG Pte Ltd

View on ClinicalTrials.gov

Summary

This is a Multi-Center, Phase II/III, open-label, single dose level (6 mg/kg) basket trial of PRL3-zumab monotherapy in solid cancer patients. The study will consist of a Screening Period (Day - 14 to Day -1) for completion of all screening assessments before the first administration of study treatment, a Treatment Period during which visits will occur every 2-week (PK T1/2 = 12 days ±2 days), once the decision to discontinue treatment for any reason, an End of Treatment (EOT) visit will be performed within 14 days ±4 days after last dose of study treatment. Safety Follow-up/EOS visit will be performed 28 days ±2 days after last dose of study treatment and survival follow-up call will be performed every month up to 6 months after EOS visit. PRL3-zumab will be administered by intravenous (i.v.) infusion till patient meets discontinuation criteria (progressive disease, clinically or per iRECIST, intolerable toxicity or withdrawal of consent). One cycle of treatment will be 4-weeks (2 infusions, 12 days±2 days apart). Patients will undergo safety assessment including laboratory tests prior to each infusion. Efficacy will be assessed by iRECIST at baseline and every 4 doses after study treatment. QoL assessments will be performed at Screening and every 4 doses ±7 days during treatment. A patient will be discontinued from study treatment if the patient progress clinically or per iRECIST criteria, or for intolerable toxicity, or if the patient withdraws consent. An EOT visit will be performed within14 days ±4 days after last study treatment dose.

Official title: An Open Label, Multicenter, Safety and Efficacy Phase II/III Study of PRL3-Zumab in Solid Tumor Patients

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2023-01-09

Completion Date

2026-02

Last Updated

2025-12-23

Healthy Volunteers

No

Interventions

BIOLOGICAL

PRL3-ZUMAB

PRL3-zumab will be administered every 2-week/dose till patient progress or develops intolerable toxicity or withdraw consent. A dose at 10-days is allowed at the first 4 doses when patients had heavier tumor burden since PRL3-zumab PK t ½ = 12 days (±2 days).

Locations (4)

Hosp. Universiti Sains Malaysia (HUSM), Kelantan

Kota Bharu, Malaysia

Beacon Hospital

Kuala Lumpur, Malaysia

Hosp. Kuala Lumpur

Kuala Lumpur, Malaysia

University Malaysia Medical Centre

Kuala Lumpur, Malaysia