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New combo therapy targets tough cancers

NCT ID NCT04421820

Disease control Sponsor: Bold Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called BOLD-100 combined with standard FOLFOX chemotherapy in people with advanced colorectal, pancreatic, stomach, or bile duct cancers that have spread or cannot be removed. The goal is to see if the combination is safe and helps control tumor growth. About 220 adults will take part, first in a small dose-finding group, then in a larger group to measure how well it works.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 220 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2020

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Be 18 years or older. 2. Be male or non-pregnant females who agree to comply with applicable contraceptive requirements of the protocol. 3. Histologically and/or cytologically confirmed gastrointestinal tumours that are metastatic or unresectable. (ARM VII): Patients must have received only 1 prior line of therapy in the metastatic setting. 4. Have measurable disease according to RECIST v1.1. 5. Have an anticipated survival of at least 16 weeks. 6. Be ambulatory, with an ECOG performance score of 0 or 1. 7. Have adequate organ function. 8. Be on stable doses of any drugs that may affect hepatic drug metabolism or renal drug excretion. 9. Be fully informed about their illness and the investigational nature of the study protocol, and sign a REB-approved Informed Consent Form (ICF). 10. (ARM VII): BRAF wild-type tumour status. Exclusion Criteria: 1. Neuropathy \> grade 2 2. Previous intolerance to or significant reaction secondary to fluorouracil or oxaliplatin. 3. Cerebrovascular accident within the past 6 months before the start of treatment. 4. History or presence of central nervous system (CNS) metastasis or leptomeningeal tumours. 5. Any serious medical conditions that might be aggravated by treatment or limit compliance. 6. Any history of serious cardiac illness. 7. Hemoptysis, cerebral, or clinically significant gastrointestinal hemorrhage in the past 6 months before the start of treatment. 8. Any other known malignancy within 3 years before the start of treatment. 9. Active gastrointestinal tract disease with malabsorption syndrome. 10. Non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular disease. 11. Treatment with radiation therapy or surgery within 4 weeks prior to starting treatment. 12. Recent history of weight loss \> 10% of current body weight in past 3 months before the start of treatment. 13. HIV-positive subjects on combination anti-retroviral therapy due to the potential for PK interactions with the study agent. 14. Concurrent use of another investigational therapy or anti-cancer therapy within 4 weeks before the start of treatment. 15. Currently breastfeeding 16. Dihydropyrimidine Dehydrogenase (DPD) deficiency 17. Current or prior treatment with potent inhibitors of Dihydropyrimidine Dehydrogenase (DPD) 18. (ARM VII): Prior exposure to BOLD-100 19. (ARM VII): Subjects with microsatellite-high (MSI-H) Tumours 20. (ARM VII): Concurrent monoclonal antibody therapy for mCRC (anti-EGFR, anti-VEGF or anti-HER2)

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Conditions

The condition(s) this trial relates to.

cholangiocarcinoma colorectal cancer colorectal neoplasm gastric cancer gastric neoplasm malignant pancreatic neoplasm pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cholangiocarcinoma Colorectal cancer Gastric cancers Pancreatic cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    22 sites in 6 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AOU L. Vanvitelli

    NOT_YET_RECRUITING

    Naples, Italy

  • Azienda Ospedaliero Universitaria Pisana

    NOT_YET_RECRUITING

    Pisa, Italy

  • Cross Cancer Institue

    RECRUITING

    Edmonton, Alberta, Canada

  • Early Phase Unit FJD START Madrid

    NOT_YET_RECRUITING

    Madrid, Spain

  • Fondazione IRCCS "Istituto Nazionale dei Tumori

    NOT_YET_RECRUITING

    Milan, Italy

  • Hospital 12 de Octubre

    NOT_YET_RECRUITING

    Madrid, Spain

  • Jewish General Hospital

    RECRUITING

    Montreal, Quebec, Canada

  • Juravinski Cancer Centre

    RECRUITING

    Hamilton, Ontario, Canada

  • Kangbuk Samsung Hospital

    RECRUITING

    Seoul, South Korea

  • Mater Miserecordiae University Hospital

    RECRUITING

    Dublin, Ireland

  • McGill University Health Centre Glen Site

    RECRUITING

    Montreal, Quebec, Canada

  • Moffitt Cancer Center

    COMPLETED

    Tampa, Florida, 33612, United States

  • National Cancer Center

    RECRUITING

    Goyang, South Korea

  • Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, Canada

  • Samsung Medical Center

    RECRUITING

    Seoul, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, South Korea

  • Severance Hospital - Yonsei University

    RECRUITING

    Seoul, South Korea

  • St. James Hospital

    RECRUITING

    Dublin, Ireland

  • St. Vincent's University Hospital

    RECRUITING

    Dublin, Ireland

  • The Ottawa Hospital Cancer Centre

    RECRUITING

    Ottawa, Ontario, Canada

  • Universitatsklinikum Bonn

    RECRUITING

    Bonn, Germany

  • University Hospital of Ulm

    RECRUITING

    Ulm, Germany

  • University of California, Los Angeles

    COMPLETED

    Santa Monica, California, 90095, United States

  • Vall Hebron Institute of Oncology (VHIO)

    NOT_YET_RECRUITING

    Barcelona, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.