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

Last updated: March 5, 2025
Sponsor: Intra-IMMUSG Pte Ltd
Overall Status: Active - Not Recruiting

Phase

2

Condition

Neuroblastoma

Neoplasms

Treatment

PRL3-zumab

Clinical Study ID

NCT04452955
226688
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with unresectable or metastatic solid tumors willing to provide signedinformed consent.

  • Histopathological diagnosis and metastatic status cancer at study entry.

  • Must have received at least 1 prior line of systemic therapy for metastatic diseasebut 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

  • Adequate organ and hematological function.

  • Measurable disease by RECIST v1.1 and iRECIST.

Exclusion

Exclusion Criteria:

  • Patient has known untreated or symptomatic central nervous system metastasis.

  • Patient is receiving systemic glucocorticoids or other immunosuppressive treatmentsfor autoimmune disease or any other medical condition.

  • Patient has experienced a severe hypersensitivity reaction to another monoclonalantibody.

  • Patient has received treatment with any systemic anti-cancer therapies within 3weeks 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

Study Design

Total Participants: 51
Treatment Group(s): 1
Primary Treatment: PRL3-zumab
Phase: 2
Study Start date:
December 12, 2020
Estimated Completion Date:
December 01, 2025

Study 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).

Connect with a study center

  • HonorHealth Research

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • St. Jude Medical Center

    Fullerton, California 92835
    United States

    Site Not Available

  • The Angeles Clinic

    Los Angeles, California 90025
    United States

    Site Not Available

  • Norton Healthcare

    Louisville, Kentucky 40200
    United States

    Site Not Available

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada 89014
    United States

    Site Not Available

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