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New pill targets Hard-to-Treat cancers in early trial

NCT ID NCT06004245

Disease control Sponsor: Vividion 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 5 times

Summary

This early-stage study is testing an experimental oral drug, VVD-133214, in people with advanced solid tumors that have specific genetic features (MSI or dMMR). The drug works by blocking a protein that helps these cancers grow. The study will check safety and how well the drug works alone or combined with other treatments. About 280 participants will take part.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 280 people

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

Started

Jan 2024

Expected to finish

May 2027

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: * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Have a microsatellite instability (MSI) and/or deficient mismatch repair (dMMR), histologically or cytologically documented advanced (unresectable and/or metastatic) solid tumor; For the combination with bevacizumab only: advanced, or metastatic colorectal adenocarcinoma (CRC) treated with at least 2 but no more than 3 prior lines of systemic therapy for the treatment of advanced CRC; For the combination with pembrolizumab only: Histologically confirmed locally advanced, or metastatic CRC with no prior systemic treatment for metastatic disease and not amenable to surgery * Have received and then progressed following, or are intolerant to, standard therapy in the advanced setting * Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 * Life expectancy of at least (≥)12 weeks * Availability of formaldehyde-fixed paraffin-embedded (FFPE) archival tumor tissue for submission to Sponsor/central laboratory for retrospective central testing; for participants without archival tissue, a biopsy from either primary or metastatic tumor lesion, deemed medically feasible, must be taken * Adequate hematologic, end-organ, and cardiovascular function, as defined in the protocol Exclusion Criteria: * Inability or unwillingness to swallow pills * Malabsorption syndrome or other condition that would interfere with enteral absorption * Known hypersensitivity or intolerance to ingredients from the study drug formulation including patients with rare genetic disorders such as galactosaemia, glucose-galactose intolerance or congenital lactase deficiency * Known uncontrolled central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) and/or carcinomatous meningitis * Known active or uncontrolled bacterial, viral, fungal, mycobacterial (including but not limited to tuberculosis and atypical mycobacterial disease), parasitic, or other infection (excluding fungal infections of nail beds), or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 2 weeks prior to the start of drug administration (related to the completion of the course of antibiotics, except if for tumor fever) or 6 months for any intracranial abscess * Has a positive test at screening for hepatitis B virus, hepatitis C virus, or for human immodeficiency virus (HIV), per local diagnostic standard and in accordance with local laws and regulations * Uncontrolled diabetes or symptomatic hyperglycemia (i.e., well controlled defined as a screening hemoglobin A1c \<8% and no urinary ketoacidosis) * Significant cardiovascular/cerebrovascular disease within 6 months prior to Day 1 of study drug administration * Alcohol or drug dependence or abuse * Patients with known Werner (WRN) syndrome * Prior treatment with any WRN helicase inhibitor * Treatment with moderate or strong CYP3A4 inducers within 14 days prior to initiation of study treatment * Treatment with moderate or strong CYP3A4 or P-glycoprotein inhibitors within 14 days prior to initiation of study treatment * Pregnancy, breastfeeding, or intention of becoming pregnant during the study Additional Exclusion Criteria for the Combination with Bevacizumab Only: * Had major surgery within 4 weeks prior to study drug administration * Deep venous thrombosis (DVT) or pulmonary embolism (PE) within 12 weeks prior to study drug administration * Known coagulopathy that increases the risk of bleeding * Patients with Grade 2+ proteinuria (exception: if 24-hour urinary protein is less than 1.0 gm/24 hours) Additional Exclusion Criteria for the Combination with Pembrolizumab Only: * Active or history of autoimmune disease or immune deficiency with some exceptions * History of interstitial lung disease or pneumonitis * Treatment with systemic immunosuppressive medication (such as corticosteroids) within 2 weeks prior to initiation of study treatment with some exceptions * Treatment with organ transplant/graft tissue

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Conditions

The condition(s) this trial relates to.

colorectal adenocarcinoma colorectal cancer colorectal neoplasm Microsatellite Instability

As listed by the trial registrant

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

Advanced solid tumors Colorectal 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

    42 sites in 11 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

Locations

  • Alfred Hospital

    RECRUITING

    Melbourne, Victoria, 3181, Australia

  • Asan Medical Center

    ACTIVE_NOT_RECRUITING

    Seoul, 05505, South Korea

  • BCCA-Vancouver Cancer Centre

    COMPLETED

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, 100142, China

  • CLCC Leon Berard Lyon

    COMPLETED

    Lyon, 69008, France

  • City of Hope Cancer Center

    RECRUITING

    Duarte, California, 91010, United States

  • City of Hope at Irvine Lennar

    RECRUITING

    Irvine, California, 91355, United States

  • Clinica Universidad de Navarra Madrid

    RECRUITING

    Madrid, Madrid, 28027, Spain

  • Clinica Universitaria de Navarra

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Duke University

    COMPLETED

    Durham, North Carolina, 27705, United States

  • Emory University School of Medicine

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Gustave Roussy

    RECRUITING

    Villejuif, 94805, France

  • Hospital Clinico Universitario de Valencia

    RECRUITING

    Valencia, Valencia, 46010, Spain

  • Kyungpook National University Chilgok Hospital

    NOT_YET_RECRUITING

    Daegu, 41404, South Korea

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • NEXT Oncology - Barcelona

    NOT_YET_RECRUITING

    Barcelona, 08023, Spain

  • NEXT Oncology-Hospital Universitario Quironsalud Madrid

    NOT_YET_RECRUITING

    Madrid, 28223, Spain

  • National Cancer Center

    NOT_YET_RECRUITING

    Gyeonggi-do, 10408, South Korea

  • Norton Cancer Institute - MDC

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Oklahoma University Health Sciences Center

    ACTIVE_NOT_RECRUITING

    Oklahoma City, Oklahoma, 73170, United States

  • Princess Margaret Cancer Center

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Rigshospitalet

    RECRUITING

    København Ø, 2100, Denmark

  • Royal Marsden Hospital (Sutton)

    RECRUITING

    Sutton, SM2 5PT, United Kingdom

  • Rutgers Cancer Institute of New Jersey

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • START Barcelona

    NOT_YET_RECRUITING

    Barcelona, 08023, Spain

  • START Los Angeles

    RECRUITING

    Los Angeles, California, 90025, United States

  • START Madrid. Centro Integral Oncologico Clara Campal

    RECRUITING

    Madrid, Madrid, 28050, Spain

  • START Midwest

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • START Mountain Region

    RECRUITING

    West Valley City, Utah, 84119, United States

  • START San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Samsung Medical Center

    RECRUITING

    Seoul, 06355, South Korea

  • Sarah Cannon Research Institute

    RECRUITING

    London, W1G 6AD, United Kingdom

  • Sarawak Public Hospital

    RECRUITING

    Kuching, Sarawak, 93586, Malaysia

    Contact Email: •••••@•••••

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam-si, 13620, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital

    RECRUITING

    Seoul, 33732, South Korea

  • St Vincents Sydney

    RECRUITING

    Darlinghurst, New South Wales, 2010, Australia

    Contact Email: •••••@•••••

  • Start Madrid-FJD, Hospital Fundacion Jimenez Diaz

    NOT_YET_RECRUITING

    Madrid, 28040, Spain

  • The Christie

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • The Sixth Hospital, affiliated with Sun Yat-sen University

    NOT_YET_RECRUITING

    Guangzhou, 510655, China

  • UZ Leuven Gasthuisberg

    RECRUITING

    Leuven, 3000, Belgium

  • University of Arizona Cancer Center

    NOT_YET_RECRUITING

    Tucson, Arizona, 85719, United States

  • University of Chicago

    NOT_YET_RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Vall d'Hebron Institute of Oncology (VHIO), Barcelona

    RECRUITING

    Barcelona, BARCELONA, 08035, Spain

  • Zhejiang Cancer Hospital

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, 310022, China

More trials for these conditions

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