Study on the Safety and Effectiveness of PRL3-Zumab for Patients with Solid Tumors

Sponsor: Intra-IMMUSG Pte Ltd

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04452955

Provider View

This clinical trial is testing a new treatment called PRL3-Zumab to see if it is safe and effective for patients with solid tumors that cannot be removed by surgery or have spread to other parts of the body.

Patient Parameters

Program Overview

This study is being conducted at multiple centers and is in Phase 2, meaning it is focused on evaluating the safety and effectiveness of PRL3-Zumab as a treatment for patients with solid tumors that are either inoperable or have metastasized. Participants will receive the treatment through an IV infusion and will be monitored regularly to assess their response and any side effects.

Description

The study includes several stages: a Screening Period (from 14 days before starting treatment), a Treatment Period with visits every two weeks, an End of Treatment visit within 14 days after stopping treatment for any reason, and a Safety Follow-up visit about two weeks after the last dose. PRL3-Zumab is given through an IV infusion until certain conditions are met, such as disease progression, intolerable side effects, or if the patient decides to stop. Each treatment cycle lasts four weeks, with two infusions given about 12 days apart.

Eligibility Criteria

Inclusion Criteria

  • Have solid tumors that cannot be surgically removed or have spread to other parts of the body.
  • Willing to sign a consent form to participate.
  • Have a confirmed diagnosis of cancer that has spread.
  • Have received at least one but no more than three previous treatments for cancer that has spread.
  • Have a life expectancy of more than six months.
  • Be in relatively good health, with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate organ and blood function.
  • Have measurable disease according to specific medical criteria.

Exclusion Criteria

  • Have untreated or symptomatic cancer that has spread to the brain or spinal cord.
  • Are taking steroids or other medications that suppress the immune system for autoimmune diseases or other conditions.
  • Have had a severe allergic reaction to a similar type of medication.
  • Have received any cancer treatments within three weeks before starting the study.
  • Have had radiation therapy within four weeks before starting the study.
  • Have received more than three previous treatments for cancer that has spread.

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