MedTrace Logo

A First-in-Human Study of PRL3-ZUMAB

NCT03191682 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-09-25

No results posted yet for this study

Summary

This study is carried out to test the safety of a study drug called PRL3-ZUMAB. PRL3-ZUMAB is an investigational drug that has not yet been approved by the Food and Drug Administration (FDA) or any other regulatory authorities for commercial purposes. This is the first study in which PRL3-ZUMAB will be given to humans. The study drug has been tested in animals and was found to be well-tolerated with minimal side effects. This research study will test different doses of the drug to see which dose is safest in people.

Conditions

Interventions

DRUG

PRL3-ZUMAB

The starting dose will be 0.3 mg/kg, administered Q2 weekly, with the subsequent dose levels being 0.9 mg/kg, 3.0 mg/kg, and 6.0 mg/kg, all administered on a Q2 weekly basis until disease progression. The investigator will monitor each subject for the occurrence of AEs. In event of infusion-related adverse events, the Investigator, in consultation with the PI, may increase the duration of the infusion over a period of up to 24 hours at their discretion. Dosing will continue in a standard 3+3 design for dose escalation.

Sponsors & Collaborators

  • INTRA-IMMUSG PRIVATE LIMITED

    collaborator UNKNOWN

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Cheng Ean Chee · National University Hospital, Singapore

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-20
Primary Completion
2027-02-20
Completion
2027-02-20

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

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 NCT03191682 on ClinicalTrials.gov