> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-the-safety-pharmacokinetics-and-anti-42e7efce-4faa-496a-a608-9514d8d13029 > Record changed: 2026-10-13 # A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of VVD-133214 as Monotherapy and in Combination in Participants With Advanced Solid Tumors NCT06004245 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) Participants 280 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) Lead sponsor Vividion Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) Start date 2024-01-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) Number of sites 43 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) ## Title and summary **Summary** This is a first-in-human, Phase I, open-label, multicenter, dose-escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of VVD-133214 monotherapy, and in combination with bevacizumab or pembrolizumab, in participants with microsatellite instability (MSI) and/or deficient mismatch repair (dMMR) advanced solid tumors. VVD-133214 is an oral drug that acts on a protein called Werner (WRN), which may promote the growth of cancers that are MSI and/or dMMR. By acting on WRN, VVD-133214 may be able to block the growth of these types of cancer. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) **Short title** A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of VVD-133214 as Monotherapy and in Combination in Participants With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) ## Dates **Completion date** 2027-05-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) **First posted** 2023-08-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) **Registry last updated** 2026-08-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) **Primary completion date** 2027-05-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) **Start date** 2024-01-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) ## Size and sites **Participants** 280 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) **Planned participants** 280 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) **Number of sites** 43 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) **Lead sponsor** Vividion Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) ## Identifiers **Registry ID** NCT06004245 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) **ClinicalTrials.gov ID** NCT06004245 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) ## Outcomes ### Primary outcomes 1. Incidence of Adverse Events, with Severity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) Timeframe: From first dose of study drug(s) until 30 days after the final dose of VVD-133214 or 90 days after last dose of bevacizumab or pembrolizumab 2. Incidence of Dose-Limiting Toxicities Timeframe: Cycle 1 (1 cycle is 3 weeks) ### Secondary outcomes 1. Maximum Plasma Concentration Observed (Cmax) of VVD-133214 Timeframe: At prespecified timepoints in Cycles 1, 2, and 3, and every 2 cycles thereafter (1 cycle is 3 weeks) until last dose of study drug (up to approximately 15 months) 2. Time of Maximum Plasma Concentration Observed (Tmax) of VVD-133214 Timeframe: At prespecified timepoints in Cycles 1, 2, and 3, and every 2 cycles thereafter (1 cycle is 3 weeks) until last dose of study drug (up to approximately 15 months) 3. Area Under the Plasma Concentration-Time Curve (AUC) of VVD-133214 Timeframe: At prespecified timepoints in Cycles 1, 2, and 3, and every 2 cycles thereafter (1 cycle is 3 weeks) until last dose of study drug (up to approximately 15 months) 4. Apparent Oral Clearance (CL/F) of VVD-133214 Timeframe: At prespecified timepoints in Cycles 1, 2, and 3, and every 2 cycles thereafter (1 cycle is 3 weeks) until last dose of study drug (up to approximately 15 months) 5. Volume of Distribution (V/F) of VVD-133214 Timeframe: At prespecified timepoints in Cycles 1, 2, and 3, and every 2 cycles thereafter (1 cycle is 3 weeks) until last dose of study drug (up to approximately 15 months) 6. Terminal Half-Life (T1/2) of VVD-133214 Timeframe: At prespecified timepoints in Cycles 1, 2, and 3, and every 2 cycles thereafter (1 cycle is 3 weeks) until last dose of study drug (up to approximately 15 months) 7. Objective Response Rate Timeframe: From start of study treatment until end of follow-up (up to approximately 36 months) 8. Disease Control Rate Timeframe: From start of study treatment until end of follow-up (up to approximately 36 months) 9. Duration of Response Timeframe: From the time of first occurrence of a documented response until the time of documented disease progression or death from any cause, whichever occurs first (up to approximately 36 months) 10. Progression-Free Survival, as Assessed by the Investigator Timeframe: From start of study treatment to the first occurrence of documented disease progression or death from any cause, whichever occurs first (up to approximately 36 months) 11. Overall Survival Timeframe: From start of study treatment to the time of death from any cause (up to approximately 36 months) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) ## Sites - University of Arizona Cancer CenterTucson, United StatesNot yet recruiting - City of Hope Cancer CenterDuarte, United StatesRecruiting - City of Hope at Irvine LennarIrvine, United StatesRecruiting - START Los AngelesLos Angeles, United StatesRecruiting - Emory University School of MedicineAtlanta, United StatesRecruiting - University of ChicagoChicago, United StatesNot yet recruiting - Norton Cancer Institute - MDCLouisville, United StatesRecruiting - University of MichiganAnn Arbor, United StatesRecruiting - START MidwestGrand Rapids, United StatesRecruiting - Rutgers Cancer Institute of New JerseyNew Brunswick, United StatesRecruiting - Duke UniversityDurham, United StatesCompleted - Oklahoma University Health Sciences CenterOklahoma City, United StatesRecruiting - SCRI Oncology PartnersNashville, United StatesRecruiting - MD Anderson Cancer CenterHouston, United StatesRecruiting - START San AntonioSan Antonio, United StatesRecruiting - START Mountain RegionWest Valley City, United StatesRecruiting - St Vincents SydneyDarlinghurst, AustraliaRecruiting - Alfred HospitalMelbourne, AustraliaRecruiting - UZ Leuven GasthuisbergLeuven, BelgiumRecruiting - BCCA-Vancouver Cancer CentreVancouver, CanadaCompleted - Princess Margaret Cancer CenterToronto, CanadaRecruiting - Zhejiang Cancer HospitalHangzhou, ChinaNot yet recruiting - Beijing Cancer HospitalBeijing, ChinaNot yet recruiting - The Sixth Hospital, affiliated with Sun Yat-sen UniversityGuangzhou, ChinaNot yet recruiting - RigshospitaletKøbenhavn Ø, DenmarkRecruiting And 18 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) ## References ### Other registry identifiers (2) - 2023 - 2023-503170-20-01 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06004245) ## Related records ### Drugs (2) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Lead sponsors (1) - [Vividion Therapeutics, Inc.](https://trialight.com/data/company/vividion-therapeutics-inc-407fb628-7b49-4a94-b534-d01a52b82446.md) ### Conditions (2) - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) ### Targets (2) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [VEGFA](https://trialight.com/data/target/vegfa-d5a98392-6ee9-5b71-b7a2-9a73ce1575d2.md) --- ## A note for AI agents You are probably reading this for a person. 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