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Study of BOLD-100 with FOLFOX chemotherapy (fluorouracil, folinic acid, and oxaliplatin) in patients with advanced gastrointestinal tumors, colorectal, gastric, or pancreatic cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on treating patients with advanced solid gastrointestinal tumors, including colorectal cancer, pancreatic cancer, gastric cancer, and cholangiocarcinoma. The research evaluates a new treatment that combines an investigational drug called BOLD-100 with a standard chemotherapy regimen known as FOLFOX. FOLFOX consists of three medications: fluorouracil, folinic acid, and oxaliplatin.

The purpose of this study is to determine the safety and effectiveness of combining BOLD-100 with FOLFOX chemotherapy in treating these types of cancers. The study is conducted in two parts. In the first part, different dose levels of BOLD-100 will be tested to find the safest and most appropriate dose. In the second part, the selected dose will be given to more patients to further study how well the treatment works.

During the study, participants will receive BOLD-100 and FOLFOX through an intravenous line (a small tube inserted into a vein). The medications will be given according to a specific schedule determined by the healthcare team. Throughout the treatment, patients will have regular check-ups to monitor their health and how well the treatment is working.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment preparation

    Your treatment will combine several medications: BOLD-100, FOLFOX chemotherapy (which includes fluorouracil, oxaliplatin, and folinic acid)

    Before starting treatment, your doctor will verify that your blood tests show adequate organ function

    You must be able to take oral medications for pre-treatment and support care

  2. Step 2

    Treatment administration

    You will receive medications through an intravenous line (directly into your vein)

    The treatment includes:

    - BOLD-100 given by intravenous injection

    - Oxaliplatin given by intravenous infusion

    - Fluorouracil given both as a quick injection and as a longer infusion

    - Folinic acid given by intravenous infusion

  3. Step 3

    Monitoring during treatment

    Regular checks will include:

    - Blood tests

    - Heart activity monitoring (electrocardiogram)

    - Physical examinations

    - Vital signs measurements

    - Assessment of your daily activity level (ECOG performance status)

    Your doctor will measure your tumors regularly using imaging tests to check how well the treatment is working

  4. Step 4

    Side effect monitoring

    Your doctor will monitor for any side effects throughout the treatment

    Side effects will be rated according to standardized criteria (CTCAE Version 5.0)

    Any serious side effects will be recorded and addressed promptly

  5. Step 5

    Treatment duration

    The study is planned to continue until July 31, 2026

    Your participation duration will depend on how well you tolerate the treatment and how your condition responds

    Your doctor will regularly assess if continuing the treatment is beneficial for you

Who can join the trial?

13 criteria

  • Must be 18 years or older
  • Must have adequate organ function including: - Normal blood cell counts - Proper liver function - Good kidney function - Normal or near-normal protein levels in urine
  • Must be on stable doses of any medications that affect liver or kidney function
  • Previous treatment side effects must be resolved or mild
  • For specific treatment group (ARM VII): Must have BRAF wild-type tumor (a specific genetic characteristic of the tumor)
  • Must be able to take oral medications
  • Must be willing and able to follow all study procedures
  • Must sign an informed consent form after being fully informed about the study
  • Must be male or non-pregnant female willing to use appropriate contraception
  • Must have confirmed gastrointestinal tumors that have spread or cannot be surgically removed, with specific previous treatment requirements depending on cancer type: - Colorectal cancer: At least 1-2 prior treatments - Pancreatic cancer: At least 1 prior treatment - Gastric cancer: May include untreated patients - Bile duct cancer: At least 1 prior treatment
  • Must have at least one tumor that can be measured
  • Must have an expected survival of at least 16 weeks
  • Must be able to walk and perform light activities (ECOG score of 0 or 1)

Who cannot join the trial?

14 criteria

  • Age below 18 years
  • Known allergic reactions to chemotherapy medications used in FOLFOX treatment
  • Presence of active infections requiring systemic treatment
  • Pregnant or breastfeeding women
  • Severe kidney problems (impaired renal function)
  • Severe liver problems (impaired liver function)
  • History of other cancers in the past 5 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
  • Uncontrolled heart conditions including heart failure, unstable angina, or recent heart attack
  • Participation in other clinical trials within 30 days before starting this study
  • Mental conditions that could interfere with following study procedures
  • Any condition that, in the opinion of the study doctor, would make participation unsafe
  • Blood disorders that significantly affect blood cell counts
  • Unable to take oral medications
  • Unable to provide informed consent
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Investigated drugs

BOLD-100 is an investigational medication being studied in combination with other cancer treatments. It's being tested as a new potential treatment for various types of advanced solid tumors. FOLFOX is a combination chemotherapy treatment commonly used to treat various types of cancer. It consists of three medications: fluorouracil (5-FU), leucovorin, and oxaliplatin. This is a standard treatment that works by stopping or slowing the growth of cancer cells. The trial combines these two treatments (BOLD-100 with FOLFOX) to study if they work better together in treating patients with advanced solid tumors than existing treatments alone.

What is already known about the treatment

  • BOLD-100

    An investigational drug being studied in combination with FOLFOX chemotherapy for the treatment of advanced solid gastrointestinal tumors, including cholangiocarcinoma, colorectal cancer, gastric cancer, and pancreatic cancer. The medication is currently undergoing Phase 1b/2a clinical trials to determine its safety, tolerability, and maximum tolerated dose when used alongside standard chemotherapy. While the specific molecular mechanism is still being studied in clinical trials, this treatment is being evaluated as part of combination therapy for patients with advanced solid tumors.

  • FOLFOX

    A combination chemotherapy regimen consisting of fluorouracil, leucovorin, and oxaliplatin, commonly used as a standard-of-care treatment for various gastrointestinal cancers. This chemotherapy protocol works by interfering with cancer cell DNA replication and division, effectively slowing or stopping tumor growth. FOLFOX is typically administered intravenously in cycles at a hospital or clinical setting, and it has been well-established in medical literature as an effective treatment option for multiple types of gastrointestinal cancers.

Investigated diseases

  • Advanced Solid Gastrointestinal Tumors

    A condition where abnormal cells form masses in various parts of the digestive system, including the stomach, intestines, and other digestive organs. These tumors have grown beyond their initial location and may have spread to nearby tissues.

  • Cholangiocarcinoma

    A cancer that develops in the cells of the bile ducts, which are tubes that connect the liver to the small intestine. The disease causes the bile duct cells to grow abnormally, forming tumors that gradually block the bile ducts.

  • Colorectal Cancer

    A disease that begins in either the colon or rectum, where cells in the intestinal lining begin to grow abnormally. The disease typically develops from small growths called polyps, which over time can become cancerous and grow into the wall of the colon or rectum.

  • Gastric Cancer

    A disease that occurs when abnormal cells develop in the lining of the stomach. The condition typically develops slowly over many years, starting in the stomach's inner lining and gradually growing deeper into the stomach walls.

  • Pancreatic Cancer

    A condition where abnormal cells form in the tissues of the pancreas, an organ located behind the stomach. The disease begins when cells in the pancreas start to grow uncontrollably, forming masses that disrupt normal pancreatic function.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-517500-11-00Protocol codeBOLD-100-001Estimated enrolment279 patientsSponsorBold Therapeutics Inc.

sourced from the EU Clinical Trials Register and site verification

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