Study on BOLD-100 with FOLFOX for Treating Advanced Solid Tumors

Sponsor: Bold Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04421820

Provider View

This clinical trial is testing a new treatment that combines BOLD-100, a special drug, with standard chemotherapy (FOLFOX) to see if it is safe and effective for patients with advanced solid tumors.

Patient Parameters

Program Overview

The study aims to find out if BOLD-100, a new drug given through an IV, can safely be combined with FOLFOX chemotherapy to treat advanced solid tumors. BOLD-100 works by targeting specific proteins in cancer cells. The trial will start with testing different doses to ensure safety, followed by a phase where more patients will receive the treatment to further evaluate its effects.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must be male or a non-pregnant female willing to use birth control.
  • Have certain types of advanced gastrointestinal cancers that cannot be removed by surgery and are suitable for FOLFOX treatment.
  • Have received at least one previous chemotherapy treatment for metastatic cancer.
  • Have measurable cancer that can be tracked.
  • Expected to live at least 16 more weeks.
  • Be able to walk and do light activities.
  • Have good organ function based on blood tests.
  • Be on stable doses of certain medications that affect liver or kidney function.
  • Have recovered from any side effects of previous treatments.
  • Be able to take oral medications.
  • Understand the study and agree to follow all procedures.
  • Sign an informed consent form.
  • (For ARM VII) Have a specific type of tumor that is BRAF wild-type.

Exclusion Criteria

  • Have severe nerve damage.
  • Have had a bad reaction to similar chemotherapy drugs.
  • Have had a stroke in the past 6 months.
  • Have cancer that has spread to the brain or spinal cord.
  • Have serious medical conditions that could worsen with treatment.
  • Have a history of serious heart problems.
  • Have had significant bleeding in the past 6 months.
  • Have another type of cancer within the past 3 years, except for certain skin or cervical cancers.
  • Have digestive issues that affect absorption.
  • Have a non-healing wound or severe circulation problems.
  • Have had recent surgery or radiation therapy.
  • Have lost more than 10% of body weight recently.
  • Are taking medications that could interfere with the study drug.
  • Are HIV-positive and on certain treatments.
  • Are breastfeeding.
  • Have a specific enzyme deficiency (DPD deficiency).
  • (For ARM VII) Have had prior treatment with oxaliplatin or BOLD-100, or have certain genetic tumor types.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.