Study on Injecting IP-001 After Heat Treatment for Patients with Advanced Colorectal, Lung, and Soft Tissue Cancers

Sponsor: Immunophotonics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05688280

Provider View

This clinical trial is testing a new treatment method where a drug called IP-001 is injected directly into tumors after they have been treated with heat. The study aims to see if this approach is safe and effective for patients with advanced colorectal, lung, and soft tissue cancers.

Patient Parameters

Program Overview

The purpose of this study is to find out if injecting a drug called IP-001 directly into tumors after they have been treated with heat can help patients with advanced colorectal, lung, and soft tissue cancers. This treatment is being tested to see if it is safe and if it can provide benefits to patients who have not had success with standard chemotherapy and immunotherapy.

Description

In this study, patients who agree to participate will first go through a screening process to check if they are eligible. This includes reviewing their medical history, current medications, symptoms, and previous treatments. Doctors will also assess the size and location of the tumors to decide which ones will be treated during the trial.

If eligible, patients will enter the treatment phase, where they will receive a standard heat treatment called radiofrequency ablation (RFA) on their tumors. After this, the drug IP-001 will be injected directly into the treated tumor. This process can be repeated every 6 weeks, up to 4 times.

After completing the treatment cycles, or if no further treatments are planned, patients will enter a follow-up phase. During this time, they will have check-ups every 6 weeks for 5 visits, or until the cancer progresses or a new treatment starts.

Eligibility Criteria

Inclusion Criteria

  • Have advanced colorectal, lung, or soft tissue cancer that has not responded to standard treatments, or are unable to receive them.
  • Expected to live more than 6 months.
  • Tumors must be 5 cm or smaller in diameter.
  • Have at least one tumor that can be treated with heat and is at least 1 cm in size.
  • Cancer must be measurable by standard criteria.
  • Be 18 years or older.
  • Be in good general health, able to carry out normal activities.
  • Have adequate blood cell counts and organ function as determined by specific tests.
  • Agree to use effective birth control if of childbearing potential, and women must have a negative pregnancy test before joining the study.

Exclusion Criteria

  • Allergic to shellfish or any components used in the trial treatment.
  • Have primary brain tumors or cancer that has spread to the brain or spinal fluid.
  • Have received other cancer treatments within 21 days before starting the trial treatment.
  • Have not fully recovered from side effects of previous treatments.
  • Have a history of other cancers, except for certain skin or in situ cancers.
  • Are taking certain steroids or other immune-suppressing medications.
  • Cannot stop blood thinners 24 hours before treatment.
  • Have severe heart disease.
  • Are HIV positive.
  • Have active Hepatitis B or C infections.

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