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

NCT07290088 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-04-16

No results posted yet for this study

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.

Conditions

  • Advanced Solid Cancers

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).

Sponsors & Collaborators

  • Kuala Lumpur General Hospital

    collaborator OTHER_GOV

  • Beacon Hospital

    collaborator OTHER

  • Hospital Universiti Sains Malaysia

    collaborator OTHER

  • University Malaysia Medical Centre

    collaborator UNKNOWN

  • Intra-IMMUSG Pte Ltd

    lead INDUSTRY

Principal Investigators

  • Prof Qi Zeng · Intra-IMMUSG Pte Ltd

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-09
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07290088 on ClinicalTrials.gov