At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- VVD-133214 (drug), Pembrolizumab (drug), Bevacizumab (drug)
- How long the study runs
- Study runs about 40 months (dates as stated)
- About the drug or intervention
- VVD-133214 — drug: VVD-133214 will be administered orally and once daily (QD) in 3-week cycles. · Pembrolizumab — drug: Pembrolizumab will be administered by intravenous (IV) infusion at a fixed dose of 200 mg on Day 1 of each 21-day cycle. · Bevacizumab — drug: Bevacizumab will be administered by intravenous (IV) infusion at a fixed dose of 7.5 mg/kg on Day 1 of each 21-day cycle.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 280
- Started
- 2024-01-25
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for advanced solid tumors
- • Phase1 - 280 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with advanced solid tumors
Where?
- • London - Sarah Cannon Research Institute
- • Manchester - The Christie
- • Sutton - Royal Marsden Hospital (Sutton)
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ regimens must have included (unless not eligible f
What the study is looking for
- ✓activity scale (ECOG) performance status score of 0 or 1
- ✓Have a microsatellite instability (MSI) and/or deficient mismatch repair (dMMR), histologically or cytologically...
- ✓For the combination with pembrolizumab only: confirmed by a biopsy that has grown locally, or that has spread CRC with no...
- ✓Presence of cancer that can be measured on scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- ✓Life expectancy of at least (≥)12 weeks
Who cannot take part
- ✗Inability or unwillingness to swallow pills
- ✗Malabsorption syndrome or other condition that would interfere with enteral absorption
- ✗Known uncontrolled central nervous system (CNS) metastases (progressing or requiring anticonvulsants or...
- ✗Has a positive test at screening for hepatitis B virus, hepatitis C virus, or for human immodeficiency virus (HIV),...
- ✗Uncontrolled diabetes or causing symptoms hyperglycemia (i.e., well controlled defined as a screening red blood cell level A1c \<8%...
See the full criteria
Where Is This Study? (3 UK sites)
Sarah Cannon Research Institute
London W1G 6AD, United Kingdom
The Christie
Manchester M20 4BX, United Kingdom
Royal Marsden Hospital (Sutton)
Sutton SM2 5PT, United Kingdom
How to Get in Touch
Vividion Clinical Trial Call Center
Sponsor contactCONTACT
