Study on PRO1160 for Treating Advanced Solid and Liquid Tumors

Sponsor: ProfoundBio US Co.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05721222

Provider View

This clinical trial is testing a new drug called PRO1160 to see if it is safe and effective for treating advanced solid tumors and blood cancers that have spread or cannot be removed by surgery.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effects of a new drug, PRO1160, in patients with advanced solid tumors or blood cancers that have spread throughout the body or cannot be surgically removed. The trial is divided into two parts: Part A will determine the best dose and schedule for administering PRO1160, while Part B will test the safety and effectiveness of this dose in treating specific cancers, including Renal Cell Carcinoma, Nasopharyngeal Carcinoma, and Non-Hodgkin Lymphoma.

Description

This clinical trial is exploring a new treatment called PRO1160, which is designed to target cancer cells. The study is for patients with advanced solid tumors or blood cancers, such as renal cell carcinoma, nasopharyngeal carcinoma, and non-Hodgkin lymphoma. The trial has two phases:

  • Part A: Dose Escalation - This phase will test different doses of PRO1160 to find the safest and most effective amount to give to patients. The drug will be given through an IV infusion every 21 days.

  • Part B: Dose Expansion - Once the best dose is determined, this phase will test how well PRO1160 works in treating the cancers. Up to 80 patients will participate, divided into groups based on their type of cancer.

Patients will continue receiving the treatment until their cancer progresses, they experience unacceptable side effects, the study ends, or they choose to stop participating. The study will also end if the patient becomes pregnant or passes away.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced or metastatic cancer, including renal cell carcinoma, nasopharyngeal carcinoma, or stage III or IV non-Hodgkin lymphoma.
  • The cancer must have returned or not responded to previous treatments.
  • Be willing to provide a sample of the tumor, either from a previous biopsy or a new one.
  • Be in good overall health, with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have measurable cancer according to specific medical criteria for each type of cancer.

Exclusion Criteria

  • Have previously received treatment targeting CD70.
  • Have another type of cancer within the past three years.
  • Have active cancer that has spread to the brain, unless it has been treated and is stable.
  • Have an uncontrolled severe infection within the past two weeks.
  • Test positive for hepatitis B, hepatitis C, or HIV.
  • Be using certain medications that affect the liver within 14 days before starting the study (for dose escalation only).
  • Other specific criteria may apply as defined by the study protocol.

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