Study on CPI-613 (Devimistat) with Hydroxychloroquine and 5-Fluorouracil or Gemcitabine for Treating Advanced Solid Tumors

Sponsor: Northwestern University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05733000

Provider View

This clinical trial is testing a new treatment combination using CPI-613 (devimistat), hydroxychloroquine, and either 5-fluorouracil or gemcitabine to see if it can help treat advanced solid tumors that have not responded to previous chemotherapy.

Patient Parameters

Program Overview

This study is exploring whether a combination of CPI-613 (devimistat), hydroxychloroquine, and either 5-fluorouracil (5-FU) or gemcitabine can effectively treat advanced solid tumors that have spread or not responded to chemotherapy. CPI-613 works by blocking the energy production that tumor cells need to grow. Hydroxychloroquine may help the immune system control tumors, while 5-FU and gemcitabine are chemotherapy drugs that kill cancer cells. The study aims to see if this combination can better treat these difficult-to-treat cancers.

Description

The main goal of this study is to find out how well the combination of devimistat (CPI-613), hydroxychloroquine (HCQ), and either 5-FU or gemcitabine works in treating advanced solid tumors. Researchers will look at how many patients respond to the treatment, how long they live without the cancer getting worse, and their overall survival. They will also assess how long the treatment effects last and how safe and tolerable the treatment is for patients.

Patients will be divided into three groups based on their type of cancer:

  • Group 1: Patients with colorectal cancer will receive devimistat, 5-FU, and HCQ.
  • Group 2: Patients with pancreatic cancer will receive devimistat, 5-FU, and HCQ.
  • Group 3: Patients with gastroesophageal cancer will receive devimistat, 5-FU, and HCQ. Patients with urothelial, ovarian, or non-small cell lung cancer will receive devimistat, gemcitabine, and HCQ. Patients with biliary tumors will receive devimistat and either gemcitabine or HCQ.

Throughout the study, patients will undergo imaging tests like CT or MRI scans and provide blood samples for analysis.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of cancer that no longer responds to standard treatments or cannot tolerate them.
  • Be 18 years or older.
  • Have measurable cancer that can be tracked using standard criteria.
  • Have imaging showing cancer spread within 6 weeks before joining the study.
  • Be in good overall health with a performance status score of 0 or 1, or 2 with special approval.
  • Have tried all available targeted therapies.
  • Meet specific blood count and organ function requirements.
  • Agree to use effective contraception during the study and for 180 days after treatment.
  • Have a negative pregnancy test before starting the study.
  • For patients with HIV, have an undetectable viral load for 6 months before joining.
  • For patients with hepatitis B or C, have the infection under control or cured.
  • Be able to understand and sign a consent form and be willing to follow study procedures.

Exclusion Criteria

  • Have not recovered from side effects of previous cancer treatments.
  • Have symptomatic brain metastases and are using corticosteroids.
  • Have severe lung diseases.
  • Have had a heart attack within 90 days before joining.
  • Are taking medications that affect heart rhythm.
  • Have had major surgery or significant injury within 21 days before joining.
  • Have active infections or other serious medical conditions.
  • Are pregnant or breastfeeding.
  • Have certain heart conditions or abnormal heart rhythms.
  • Have pre-existing eye conditions affecting the retina.
  • Cannot swallow or absorb oral medication.
  • Have allergies to any study drugs.
  • Have poorly controlled diabetes.

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