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
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 280 (estimated) |
| Sponsor | Vividion Therapeutics, Inc. Industry-sponsored |
| Drugs / interventions | bevacizumab, pembrolizumab, chemotherapy, immunotherapy |
| Locations | 55 sites (Tucson, Arizona and 54 other locations) |
| Status | Recruiting |
| Started | January 25, 2024 |
| Main results expected | May 31, 2027 |
| Study ends | May 31, 2027 |
| Registry record updated | October 21, 2026 |
| Trial ID | NCT06004245 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
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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
- Study coordinator: Vividion Clinical Trial Call Center
- Email: clinicaltrials@vividion.com
- Phone: 1+ 858-345-9752 (U.S. Only)
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.