Clinical trial Recruiting at 36 sites Phase 1 Interventional Ages 18 and up

Evaluating a new treatment for advanced solid tumors

Official title: A Phase I, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-Tumor Activity of VVD-133214 as Monotherapy and in Combination in Participants With Advanced Solid Tumors Harboring Microsatellite Instability (MSI) and/or Deficient Mismatch Repair (dMMR)

Run by Vividion Therapeutics, Inc. · NCT06004245 · Data updated 2026-11-12

This study is testing a new treatment for people with advanced solid tumors that have specific genetic features to see if it can help shrink their tumors when used alone or with another medication.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment280 (estimated)
SponsorVividion Therapeutics, Inc.
Industry-sponsored
Drugs / interventionsbevacizumab, pembrolizumab, chemotherapy, immunotherapy
Locations55 sites (Tucson, Arizona and 54 other locations)
StatusRecruiting
StartedJanuary 25, 2024
Main results expectedMay 31, 2027
Study endsMay 31, 2027
Registry record updatedOctober 21, 2026
Trial IDNCT06004245 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals with advanced solid tumors exhibiting MSI or dMMR who have progressed after standard therapies.

Probably not a fit

Patients with solid tumors that do not exhibit MSI or dMMR may not benefit from this treatment.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase I clinical trial is designed to assess the safety, pharmacokinetics, and anti-tumor activity of RO7589831, both alone and in combination with pembrolizumab, in patients with advanced solid tumors characterized by microsatellite instability (MSI) or deficient mismatch repair (dMMR). The study involves a multicenter, open-label approach with dose-escalation and expansion phases to determine the optimal dosing and effectiveness of the treatment. Participants must have measurable disease and a documented history of progression following standard therapies.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that are difficult to treat.

How similar studies have gone: Other studies targeting MSI and dMMR tumors have shown promising results, suggesting potential for success with this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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 monotherapy only (solid tumor): Have received and then progressed following or are intolerant to at least 2 standard treatment regimens in the advanced setting including standard chemotherapy or checkpoint inhibitors according to tumor type.
* 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 and demonstrated progressive disease or intolerance to the last regimen. Prior treatment regimens must have included (unless not eligible for or intolerant to any of these agents): An immune checkpoint inhibitor (if available as standard of care), Fluoropyrimidine, Irinotecan and/or oxaliplatin, +/- an anti-VEGF monoclonal antibody, Participants with RAS WT tumors may have received anti-epidermal growth factor receptor (EGFR) monoclonal antibody based on Investigator discretion. Treatment with adjuvant/neoadjuvant chemotherapy and/or immunotherapy will count as a line of therapy for advanced disease if progression occurred during or within 12 months of completing the treatment.
* 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.
* 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

Where it's running

  • City of Hope Cancer Center
    Duarte, California, United States
    Recruiting
  • City of Hope at Irvine Lennar
    Irvine, California, United States
    Recruiting
  • START Los Angeles
    Los Angeles, California, United States
    Recruiting
  • Emory University School of Medicine
    Atlanta, Georgia, United States
    Recruiting
  • Norton Cancer Institute - MDC
    Louisville, Kentucky, United States
    Recruiting
  • University of Michigan
    Ann Arbor, Michigan, United States
    Recruiting
Show 44 more locations
  • START Midwest
    Grand Rapids, Michigan, United States
    Recruiting
  • Rutgers Cancer Institute of New Jersey
    New Brunswick, New Jersey, United States
    Recruiting
  • SCRI Oncology Partners
    Nashville, Tennessee, United States
    Recruiting
  • MD Anderson Cancer Center
    Houston, Texas, United States
    Recruiting
  • START San Antonio
    San Antonio, Texas, United States
    Recruiting
  • START Mountain Region
    West Valley City, Utah, United States
    Recruiting
  • St Vincents Sydney
    Darlinghurst, New South Wales, Australia
    Recruiting
  • Alfred Hospital
    Melbourne, Victoria, Australia
    Recruiting
  • Princess Margaret Cancer Center
    Toronto, Ontario, Canada
    Recruiting
  • Zhejiang Cancer Hospital
    Hangzhou, Zhejiang, China
    Recruiting
  • Beijing Cancer Hospital
    Beijing, China
    Recruiting
  • The Sixth Hospital, affiliated with Sun Yat-sen University
    Guangzhou, China
    Recruiting
  • Rigshospitalet
    København Ø, Denmark
    Recruiting
  • Gustave Roussy
    Villejuif, France
    Recruiting
  • Sarawak Public Hospital
    Kuching, Sarawak, Malaysia
    Recruiting
  • Kyungpook National University Chilgok Hospital
    Daegu, South Korea
    Recruiting
  • National Cancer Center
    Gyeonggi-do, South Korea
    Recruiting
  • Seoul National University Bundang Hospital
    Seongnam-si, South Korea
    Recruiting
  • Seoul National University Hospital
    Seoul, South Korea
    Recruiting
  • Asan Medical Center
    Seoul, South Korea
    Recruiting
  • Samsung Medical Center
    Seoul, South Korea
    Recruiting
  • Severance Hospital
    Seoul, South Korea
    Recruiting
  • Vall d'Hebron Institute of Oncology (VHIO), Barcelona
    Barcelona, Barcelona, Spain
    Recruiting
  • Clinica Universidad de Navarra Madrid
    Madrid, Madrid, Spain
    Recruiting
  • START Madrid. Centro Integral Oncologico Clara Campal
    Madrid, Madrid, Spain
    Recruiting
  • Clinica Universitaria de Navarra
    Pamplona, Navarre, Spain
    Recruiting
  • Hospital Clinico Universitario de Valencia
    Valencia, Valencia, Spain
    Recruiting
  • Sarah Cannon Research Institute
    London, United Kingdom
    Recruiting
  • The Christie
    Manchester, United Kingdom
    Recruiting
  • Royal Marsden Hospital (Sutton)
    Sutton, United Kingdom
    Recruiting
  • University of Arizona Cancer Center
    Tucson, Arizona, United States
    Not yet recruiting
  • The Angeles Clinic and Research Institute
    Los Angeles, California, United States
    Not yet recruiting
  • University of Chicago
    Chicago, Illinois, United States
    Not yet recruiting
  • Duke University
    Durham, North Carolina, United States
    Completed
  • Oklahoma University Health Sciences Center
    Oklahoma City, Oklahoma, United States
    Completed
  • West Virginia University Cancer Institute
    Morgantown, West Virginia, United States
    Not yet recruiting
  • Cliniques universitaires de Saint Luc
    Brussels, Belgium
    Not yet recruiting
  • UZ Leuven Gasthuisberg
    Ghent, Belgium
    Not yet recruiting
  • UZ Gent
    Ghent, Belgium
    Not yet recruiting
  • BCCA-Vancouver Cancer Centre
    Vancouver, British Columbia, Canada
    Completed
  • CLCC Leon Berard Lyon
    Lyon, France
    Completed
  • Institut regional du Cancer de Montpellier
    Montpellier, France
    Not yet recruiting
  • Hôpital saint Antoine
    Paris, France
    Not yet recruiting
  • Hopital europeen Georges Pompidou
    Paris, France
    Not yet recruiting

+5 more sites. See ClinicalTrials.gov for the full list.

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.