Can blocking a DNA repair protein make immunotherapy work better against colorectal cancer?

NCT ID NCT07811193

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

First seen Sep 09, 2026 · Last updated Sep 17, 2026 · Updated 3 times

Summary

Researchers are testing a new drug, VVD-133214, combined with pembrolizumab in people with advanced colorectal cancer that has MSI and/or dMMR. These tumors rely on a protein called Werner helicase to survive, and VVD-133214 is designed to block it. The trial compares the combination to pembrolizumab alone to see if it improves progression-free survival and to find the best dose. Participants have not received prior treatment for advanced disease and will receive the combination for as long as it helps.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: VVD-133214, an experimental drug that blocks the Werner helicase protein, given with pembrolizumab
What this could lead to: If the combination works, it could offer a new first-line option for advanced colorectal cancer with MSI and/or dMMR, a group that needs better treatments.
What could go wrong: This is a phase 2 trial, so it may not show a clear benefit over pembrolizumab alone. Blocking Werner helicase could cause side effects, and the combination may not work for everyone.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 140 people

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

Started

Sep 2026

Expected to finish

Dec 2030

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 known microsatellite instability (MSI) and/or deficient mismatch repair (dMMR) tumor status confirmed per local standard of care (SoC), and have histologically or cytologically documented advanced (unresectable and/or metastatic) colorectal adenocarcinoma (CRC) * No prior systemic treatment for metastatic disease and not amenable to curative resection * Participants must have documented MSI and/or dMMR tumor status determined as part of the routine diagnostic workup in a certified laboratory * Availability of formaldehyde-fixed paraffin-embedded (FFPE) archival tumor tissue for submission to Sponsor/central laboratory for retrospective central testing including a copy of a redacted pathology report if available * Presence of measurable disease according to RECIST v1.1 * Adequate hematologic and end-organ function, defined using laboratory results obtained within 14 days prior to first dose of study treatment * Females of childbearing potential must have negative serum pregnancy test before starting study treatment Exclusion Criteria: * Prior systemic treatment for advanced CRC. Participants may have received prior adjuvant chemotherapy as long as disease progression occurred at least 12 months after the last dose of adjuvant treatment * Prior treatment with adjuvant immunotherapy (e.g., anti-PD-1, anti-PD-L1, anti-PD-L2 agent, or anti-CTLA-4 agent, or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways, including prior therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents, etc.) * Known active or uncontrolled central nervous system (CNS) or brain metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) and/or carcinomatous meningitis * Patients with active or history of autoimmune disease or immune deficiency that has required treatment in past 2 years * History of malignancy other than CRC, within 5 years prior to screening. Participants with Lynch syndrome are not excluded. * Participants requiring treatment with systemic immunosuppressive medication (such as corticosteroids) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment * Participants with active hepatitis B, hepatitis C or HIV * Participants with known Werner Syndrome (WRN) * Prior treatment with any WRN helicase inhibitor

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Conditions

The condition(s) this trial relates to.

colorectal adenocarcinoma Colorectal Neoplasms, Hereditary Nonpolyposis

As listed by the trial registrant

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

Colorectal adenocarcinoma

How to take part

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

The places running it

121 sites in 21 countries. The list below names each one and where it is.
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 ↗
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

A.O.U. Universita' Degli Studi Della Campania Luigi Vanvitelli - Oncoematologia
NOT_YET_RECRUITING

Naples, 80131, Italy
ASST Grande Ospedale Metropolitano Niguarda - Oncologia Falck
NOT_YET_RECRUITING

Milan, Milan, 20162, Italy
AZ Delta - Digestive oncology
NOT_YET_RECRUITING

Roeselare, 8800, Belgium
Ankara Bilkent Sehir Hastanesi
NOT_YET_RECRUITING

Bilkent Çankaya, Ankara, 6800, Turkey (Türkiye)
Ankara Etlik Sehir Hastanesi
NOT_YET_RECRUITING

Yenimahalle, 6170, Turkey (Türkiye)
Asan Medical Center | Oncology
NOT_YET_RECRUITING

Seoul, Seoul, 05505, South Korea
Asklepios Klinik Altona - Onkologie, Hämatologie, Palliativmedizin, Rheumatologie und Pneumologie
NOT_YET_RECRUITING

Hamburg, Free and Hanseatic City of Hamburg, 22763, Germany
Athens Medical Center S.A./ European Interbalkan Medical Center - 4th Department of Medical Oncology
NOT_YET_RECRUITING

Pylaia, Thessaloniki, 570 01, Greece
Beijing Cancer Hospital - Oncology Department
NOT_YET_RECRUITING

Beijing, Beijing Municipality, 100142, China
Białostockie Centrum Onkologii im. M. Skłodowskiej-Curie w Białymstoku Oddział Onkologii Klinicznej
NOT_YET_RECRUITING

Bialystok, 15-027, Poland
Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit
NOT_YET_RECRUITING

Detroit, Michigan, 48202, United States
CHRU de Besancon - Hopital Jean Minjoz - Medical Oncology
NOT_YET_RECRUITING

Besançon, 25030, France
CHU Brest - Hopital La Cavale Blanche - service oncologie medicale
NOT_YET_RECRUITING

Brest, Brittany Region, 29200, France
CHU Helora - Hopital de La Louvière - Site Jolimont - Oncology department
NOT_YET_RECRUITING

La Louvière, Hainaut, 7100, Belgium
Cengild G.I. Medical Centre - Curie Oncology KL
NOT_YET_RECRUITING

Kuala Lumpur, 59200, Malaysia
Centro Medico Fleischer
NOT_YET_RECRUITING

Buenos Aires, Buenos Aires, C1414, Argentina
Centrum Medyczne Pratia Poznan
NOT_YET_RECRUITING

Skorzewo, 60-185, Poland
Chang Gung Memorial Hospital Kaohsiung
NOT_YET_RECRUITING

Kaohsiung City, Kaohsiung, 803, Taiwan
Chang Gung Memorial Hospital at Linkou
NOT_YET_RECRUITING

Taipei, Taipei, 10507, Taiwan
Chi Mei Medical Center, Yongkang Branch
NOT_YET_RECRUITING

Tainan, 71004, Taiwan
Comarch Healthcare SA Centrum Medyczne iMed24
NOT_YET_RECRUITING

Krakow, 31-864, Poland
Complexo Hospitalario Universitario De Santiago | Oncologia
NOT_YET_RECRUITING

Santiago de Compostela, A Coruña, 15706, Spain
Curie Oncology | Farrer
NOT_YET_RECRUITING

Singapore, 329563, Singapore
DRK Kliniken Berlin-Köpenick - Darmzentrum
NOT_YET_RECRUITING

Berlin, State of Berlin, 12559, Germany
Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina
NOT_YET_RECRUITING

Otwock, 05-400, Poland
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
NOT_YET_RECRUITING

Roma, 00168, Italy
Fujian Cancer Hospital
NOT_YET_RECRUITING

Fuzhou, Fujian, 350014, China
Fundacao Pio XII - Hospital de Cancer de Barretos
NOT_YET_RECRUITING

Jaú, São Paulo, 14784-400, Brazil
Fundación Intecnus
NOT_YET_RECRUITING

Bariloche, Río Negro Province, RP82 8400, Argentina
Gaziantep Sehir Hastanesi -Medical Oncology Department
NOT_YET_RECRUITING

Gaziantep, 27470, Turkey (Türkiye)
General Hospital Of Athens Alexandra-Plasma Cell Dyscrasias Unit, Department of Clinical Therapeutics, N.K.U.A
NOT_YET_RECRUITING

Athens, Attica, 115 28, Greece
General University Hospital Of Patras- Division of Oncology, Department of Medicine
NOT_YET_RECRUITING

Pátrai, 265 04, Greece
Grupo Medico ASSET S.C
NOT_YET_RECRUITING

Benito Juárez, 03100, Mexico
HagaZiekenhuis - Oncologie Interne Geneeskunde
NOT_YET_RECRUITING

The Hague, 2545 AA, Netherlands
Harbin Medical University Cancer Hospital
NOT_YET_RECRUITING

Harbin, Heilongjiang, 150000, China
Hong Kong United Oncology Centre
NOT_YET_RECRUITING

Kowloon, Kowloon, 00000, Hong Kong
Hospital Araujo Jorge Associaçao de Combate ao Cancer em Goias
NOT_YET_RECRUITING

Goiânia, Goiás, 74605-070, Brazil
Hospital Clinico Universitario De Valencia | Oncologia
NOT_YET_RECRUITING

Valencia, Valencia, 46010, Spain
Hospital Evangélico de Cachoeiro de Itapemirim
NOT_YET_RECRUITING

Vitória, Espírito Santo, 29047-660, Brazil
Hospital Italiano de Buenos Aires
NOT_YET_RECRUITING

Buenos Aires, Buenos Aires, C1199ABB, Argentina
Hospital Sirio Libanes - Oncology_Sao Paulo
NOT_YET_RECRUITING

São Paulo, São Paulo, 01308-050, Brazil
Hospital Umum Sarawak (Sarawak General Hospital) SGH
NOT_YET_RECRUITING

Kuching, Sarawak, 93586, Malaysia
Hospital Universitari Vall D Hebron | Oncologia
NOT_YET_RECRUITING

Barcelona, Barcelona, 08035, Spain
Hospital Universitario Ramon Y Cajal | Oncologia Medica
NOT_YET_RECRUITING

Madrid, Madrid, 28034, Spain
Hospital Universitario Virgen De La Victoria | Oncologia Medica
NOT_YET_RECRUITING

Málaga, Málaga, 20910, Spain
Hospital Universitrio Dr. José Eleuterio González. Servicio de Oncologia
NOT_YET_RECRUITING

Monterrey, 64460, Mexico
Hospital Wanita Dan Kanak Kanak Sabah - Oncology and Radiotherapy
NOT_YET_RECRUITING

Kota Kinabalu, Sabah, 88996, Malaysia
Hospital Zambrano Hellion
NOT_YET_RECRUITING

Monterrey, Nuevo León, 66278, Mexico
Hospital del Mar | Oncologia
NOT_YET_RECRUITING

Barcelona, 08003, Spain
Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia
NOT_YET_RECRUITING

Rozzano, 20089, Italy
Institut Jules Bordet - Clinique D'Oncology
NOT_YET_RECRUITING

Brussels, Brussels Capital, 1070, Belgium
Instituto Alexander Fleming
NOT_YET_RECRUITING

Buenos Aires, Buenos Aires, C1426ANZ, Argentina
Instituto Nacional de Cancerología
NOT_YET_RECRUITING

Mexico City, Mexico City, 14080, Mexico
Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E. - Serviço de Oncologia Médica
NOT_YET_RECRUITING

Lisbon, 1099-023, Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E. - Serviço de Oncologia Médica
NOT_YET_RECRUITING

Porto, 4200-072, Portugal
Instituto do Cancer do Estado de Sao Paulo
NOT_YET_RECRUITING

São Paulo, São Paulo, 01246-000, Brazil
Investigaciones Oncológicas C Colón
NOT_YET_RECRUITING

Mar Del Plata, Buenos Aires,, 7600, Argentina
Istituto Europeo di Oncologia s.r.l - Sviluppo di nuovi farmaci per Terapie Innovative
NOT_YET_RECRUITING

Milan, 20141, Italy
Kartal Dr Lutfi Kirdar Sehir Hastanesi- Medical Oncology
NOT_YET_RECRUITING

Istanbul, 34865, Turkey (Türkiye)
Keelung Chang Gung Memorial Hospital - Division of Hematology and Oncology
NOT_YET_RECRUITING

Keelung, 204201, Taiwan
Klinikum Oldenburg - Klinik für Onkologie und Hämatologie
NOT_YET_RECRUITING

Oldenburg, Lower Saxony, 26133, Germany
Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)
NOT_YET_RECRUITING

Frankfurt am Main, Hesse, 60488, Germany
Laiko General Hospital Of Athens- Oncology Department
NOT_YET_RECRUITING

Athens, 11526, Greece
Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH-Medizinische Klinik 2
NOT_YET_RECRUITING

Schweinfurt, Bavaria, 97422, Germany
Mary Babb Randolph Cancer Center
NOT_YET_RECRUITING

Morgantown, West Virginia, 26505, United States
Mazowiecki Szpital Wojewódzki Siedleckie Centrum Onkologii Oddział Onkologii Klinicznej i Radioterapii
NOT_YET_RECRUITING

Siedlce, 08-110, Poland
Metropolitan General Hospital -Oncologic Clinical Trials and Research Clinic
NOT_YET_RECRUITING

Cholargos/ Athens, 155 62, Greece
NAIC - Instituto do Cancer
NOT_YET_RECRUITING

Bauru, São Paulo, 17033-490, Brazil
Narodowy Instytut Onkologii im. Marii Skłodowskiej Curie Państwowy Instytut Badawczy- Oddział Warszawa Wawelska
NOT_YET_RECRUITING

Warsaw, 02-034, Poland
National Cancer Center Singapore - Oncology Department
RECRUITING

Singapore, 168583, Singapore
National Cheng Kung University Hospital
NOT_YET_RECRUITING

Tainan, Tainan, 704, Taiwan
National University Cancer Institute (NCIS)
NOT_YET_RECRUITING

Singapore, 119074, Singapore
Nucleo de Ensino e Pesquisa do Hospital de Clinicas de Ijuí
NOT_YET_RECRUITING

Ijuí, Rio Grande do Sul, 98700-000, Brazil
Oncare Viaducto Nápoles
NOT_YET_RECRUITING

Mexico City, 3810, Mexico
OncoCare Cancer Centre | Gleneagles Medical Centre
NOT_YET_RECRUITING

Singapore, 258499, Singapore
Opolskie Centrum Onkologii
NOT_YET_RECRUITING

Opole, 45-061, Poland
Pratia McM Kraków
NOT_YET_RECRUITING

Krakow, 30-727, Poland
Pratia Wroclaw
NOT_YET_RECRUITING

Wroclaw, 50-417, Poland
Prince of Wales Hospital
NOT_YET_RECRUITING

Shatin, New Territories, 00000, Hong Kong
Queen Mary Hospital
NOT_YET_RECRUITING

Hong Kong, Hong Kong SAR, 00000, Hong Kong
Renati Innovation SAPI de CV
NOT_YET_RECRUITING

Guadalajara, 44680, Mexico
START Research Portugal - ULSS Maria - Unidade de Ensaios de Fase I Start Lisbon
NOT_YET_RECRUITING

Lisbon, 1649-035, Portugal
Saint Savvas Oncology Hospital -1st Internal Medicine - Oncology Department
NOT_YET_RECRUITING

Athens, Attica, 115 22, Greece
Samsung Medical Center | Oncology
NOT_YET_RECRUITING

Seoul, Seoul, 06351, South Korea
Sanatorio Allende | Departamento de Investigación Clínica
NOT_YET_RECRUITING

Córdoba, Córdoba Province, X5000JHQ, Argentina
Sanatorio Parque - Oncology
NOT_YET_RECRUITING

Rosario, Santa Fe Province, S2000GAP, Argentina
Seoul National University Bundang Hospital | Oncology
NOT_YET_RECRUITING

Seongnam-si, Gyeonggi-do, 13620, South Korea
Seoul National University Hospital | Oncology
NOT_YET_RECRUITING

Jongno -Gu, Seoul, 03080, South Korea
Severance Hospital | Oncology
NOT_YET_RECRUITING

Seoul, Seoul, 03722, South Korea
Shandong University - Shandong Cancer Hospital
NOT_YET_RECRUITING

Jinan, Shandong, 250117, China
Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department
NOT_YET_RECRUITING

Hangzhou, Zhejiang, 310016, China
Sunway Medical Centre - Medical Oncology
NOT_YET_RECRUITING

Subang Jaya, Selangor, 47500, Malaysia
Sunway Medical Centre Penang - Department of Clinical Oncology
NOT_YET_RECRUITING

Perai, Pulau Pinang, 13700, Malaysia
Taichung Veterans General Hospital | Division of Colorectal Surgery
NOT_YET_RECRUITING

Taichung, 407219, Taiwan
Taipei Veterans General Hospital
NOT_YET_RECRUITING

Taipei, Taipei, 11217, Taiwan
The First Affiliated Hospital of Bengbu Medical College
NOT_YET_RECRUITING

Bengbu, Anhui, 233004, China
The Sixth Affiliated Hospital, Sun Yat-sen University
NOT_YET_RECRUITING

Guangzhou, Guangdong, 510655, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
NOT_YET_RECRUITING

Wuhan, Hubei, 430030, China
Trakya Univ. Tip Fak.
NOT_YET_RECRUITING

Edirne, 22030, Turkey (Türkiye)
UZ Gent - Digestive Oncology
NOT_YET_RECRUITING

Ghent, 9000, Belgium
UZ Leuven - Digestive oncology
NOT_YET_RECRUITING

Leuven, Flemish Brabant, 3000, Belgium
Unicancer Dijon - Centre Georges Francois Leclerc - Oncologie medicale
NOT_YET_RECRUITING

Dijon, 21000, France
Unicancer Marseille - Institut Paoli-Calmettes - Oncologie medicale
NOT_YET_RECRUITING

Marseille, 13009, France
Unidade Local de Saúde de Coimbra, E.P.E. - Hospitais da Universidade de Coimbra - Serviço de Oncologia
NOT_YET_RECRUITING

Coimbra, 3004-561, Portugal
Unidade Local de Saúde de São José, E.P.E - Hospital de Santo António dos Capuchos - Serviço de Oncologia Médica
NOT_YET_RECRUITING

Lisbon, 1169-050, Portugal
Unidade de Pesquisas Clinicas em Oncologia
NOT_YET_RECRUITING

Pelotas, Rio Grande do Sul, 96020-080, Brazil
Universitaetsklinikum Essen - Innere Klinik (Tumorforschung)
NOT_YET_RECRUITING

Essen, North Rhine-Westphalia, 45147, Germany
Universiti Malaya Medical Centre - Clinical Oncology Department
NOT_YET_RECRUITING

Kuala Lumpur, 59100, Malaysia
University College Hospital | Cancer Clinical Trials Unit
NOT_YET_RECRUITING

London, Greater London, NW1 2PG, United Kingdom
University Hospital Coventry | Oncology
NOT_YET_RECRUITING

Coventry, West Midlands, CV22DX, United Kingdom
University of Arizona Cancer Center - North Campus
NOT_YET_RECRUITING

Tucson, Arizona, 85719, United States
University of Michigan Rogel Cancer Center
NOT_YET_RECRUITING

Ann Arbor, Michigan, 48109, United States
UniversitätsSpital Zürich (USZ) - Klinik für Medizinische Onkologie und Hämatologie
WITHDRAWN

Zurich, Canton of Zurich, 8091, Switzerland
Universitätsklinikum Ulm - Klinik für Innere Medizin I
NOT_YET_RECRUITING

Ulm, Baden-Wurttemberg, 89081, Germany
VM Medical Park Samsun Hospital Medical Oncology Department
NOT_YET_RECRUITING

Samsun, 55200, Turkey (Türkiye)
West China Hospital Sichuan University
NOT_YET_RECRUITING

Chengdu, Sichuan, 610041, China
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu Oddział Onkologiczny z Pododdziałem Dziennej Chemioterapii
NOT_YET_RECRUITING

Przemyśl, 37-700, Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
NOT_YET_RECRUITING

Lodz, 93-513, Poland
Yunnan Cancer Hospital
NOT_YET_RECRUITING

Kunming, Yunnan, 650118, China
Zhejiang Cancer Hospital
NOT_YET_RECRUITING

Hangzhou, Zhejiang, 310022, China
Zhongshan Hospital, Fudan University
NOT_YET_RECRUITING

Shanghai, Shanghai Municipality, 200032, China
İstanbul Medeniyet Üniversitesi Göztepe Süleyman Yalçın Şehir Hastanesi
NOT_YET_RECRUITING

Kadıköy, Istanbul, 34722, Turkey (Türkiye)

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