Study on [225Ac]-FPI-1434 Injection for Patients with Advanced Solid Tumors

Sponsor: Fusion Pharmaceuticals Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03746431

Provider View

This clinical trial is testing a new treatment called [225Ac]-FPI-1434 Injection to see if it is safe and effective for patients with advanced solid tumors that have not responded to standard treatments. The study aims to find the best dose for future research.

Patient Parameters

Program Overview

This study is the first of its kind to test [225Ac]-FPI-1434, a new treatment for patients with advanced solid tumors. The trial will assess the safety, tolerability, and initial effectiveness of this treatment. It will also determine the best dose to use in future studies. The treatment is being tested in patients whose tumors show uptake of a specific imaging agent, [111In]-FPI-1547, which helps identify suitable candidates for the therapy.

Description

The study is divided into two phases:

Phase 1: This phase will test different doses of [225Ac]-FPI-1434 to find the safest and most effective dose. It includes single and multiple dose groups, as well as a group that receives an additional antibody treatment (FPI-1175) before the main treatment. The treatment cycles repeat every 42 days.

Phase 2: This phase will further evaluate the treatment in specific types of tumors, with or without the additional antibody treatment, based on the results from Phase 1. The decision to include the antibody will depend on safety and effectiveness data from the first phase.

Eligibility Criteria

Inclusion Criteria

  • Have an advanced solid tumor that has not responded to standard treatments, or for which no standard treatment is available or suitable.
  • Have measurable or evaluable disease according to specific medical criteria.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a life expectancy of more than 3 months.
  • Provide a tumor tissue sample for specific testing, although this is not required before joining the study.
  • Have adequate heart, kidney, liver function, and bone marrow reserves.
  • Be able to understand and sign a consent form.

Phase 2 Specific:

  • Have a specific type of advanced solid tumor, such as endometrial, cervical, ovarian, or certain types of breast cancer, among others.
  • Have measurable disease and have not responded to standard treatments or have no suitable standard treatment options.

Imaging Eligibility:

  • Show sufficient target expression in at least one tumor site after specific imaging tests before starting the treatment cycle.

Exclusion Criteria

  • Have received a similar type of treatment within the last 6 months.
  • Cannot undergo required imaging procedures.
  • Have uncontrolled brain metastasis needing treatment.
  • Have had cancer treatment or radiation therapy within 14 days before starting the study.
  • Have another progressing cancer or one that needed treatment in the last 3 years, except for certain skin cancers or in situ cancers that have been treated.
  • Have significant side effects from previous treatments, except for hair loss.
  • Have had an organ or stem cell transplant.
  • Have had certain chemotherapy drugs in the past.
  • Have high levels of protein in the urine.
  • Have allergies or contraindications to the study drugs.
  • Have uncontrolled illnesses, such as infections, heart failure, or psychiatric conditions.
  • Have received high-dose radiation to large areas of the bone marrow.

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