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VVD-133214

Phase 2

Colorectal Adenocarcinoma | Small molecule | Oncology |Bayer AG|Trials Updated: Sep 9, 2026

VVD-133214 development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Aug 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment140

FDA Designations

No designations recorded

VVD-133214 clinical trials

VVD-133214 · 1 trial · 1 indication

Phase 2 1
NCT07811193A Study to Evaluate the Efficacy of VVD-133214 in Combination With Pembrolizumab Compared With Pembrolizumab Alone in Participants With Advanced Cancer of the Colon or RectumColorectal Adenocarcinoma
NOT YET_RECRUITING140 Analytics
PHASE2NOT YET_RECRUITING
A Study to Evaluate the Efficacy of VVD-133214 in Combination With Pembrolizumab Compared With Pembrolizumab Alone in Participants With Advanced Cancer of the Colon or Rectum
Colorectal AdenocarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Landmark progression-free survival (PFS) rate at 6 months, as assessed by the investigator
From start of study treatment until end of follow-up (up to approximately 36 months)

Defined as the proportion of participants who are alive and free from disease progression as per RECIST v1.1

Secondary Endpoints

Incidence and severity of Adverse Events (AEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0)
From start of study treatment up to 30 days following the last dose of study drug (100 days after last administration of pembrolizumab)
Recommended Phase 2 Dose (RP2D) of VVD-133214 in combination with pembrolizumab
From start of study treatment until end of follow-up (up to approximately 36 months)
Maximum plasma concentration observed (Cmax) following single and multiple doses of VVD-133214
Predose and multiple timepoints post-dose, up to approximately 36 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
VVD-133214 Dose 1 + PembrolizumabEXPERIMENTALParticipants will receive VVD-133214 in combination with pembrolizumab
VVD-133214 Dose 2 + PembrolizumabEXPERIMENTALParticipants will receive VVD-133214 in combination with pembrolizumab
PembrolizumabACTIVE_COMPARATORParticipants will receive pembrolizumab only (monotherapy)

Interventions

NameTypeDescription
VVD-133214DRUGVVD-133214 will be administered orally
PembrolizumabDRUGPembrolizumab will be administered by intravenous infusion (IV) every three weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites121

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 adv...

Countries:United StatesArgentinaBelgiumBrazilChinaFranceGermanyGreeceHong KongItalyMalaysiaMexicoNetherlandsPolandPortugalSingaporeSouth KoreaSpainTaiwanTurkey (Türkiye)United Kingdom
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Frequently asked questions about VVD-133214

What is VVD-133214 used for?

VVD-133214 is an investigational small molecule being studied for colorectal adenocarcinoma, a type of cancer of the colon or rectum. It is being developed for patients with advanced disease and is evaluated in combination with pembrolizumab. It is not yet approved for any use and remains in clinical development.

What phase is VVD-133214 in?

VVD-133214 is in Phase 2 clinical development. The single registered trial, NCT07811193, is a Phase 2 study and is currently listed as not yet recruiting. No Phase 3 trial has been registered, and the drug has not completed any trials to date.

Who is developing VVD-133214?

VVD-133214 is being developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the sponsor of the Phase 2 study evaluating the drug in colorectal adenocarcinoma. The program is in the oncology therapeutic area.

What clinical trials is VVD-133214 in?

VVD-133214 is being studied in one registered trial, NCT07811193, titled a study to evaluate the efficacy of VVD-133214 in combination with pembrolizumab compared with pembrolizumab alone in participants with advanced cancer of the colon or rectum. The Phase 2 trial plans to enroll 140 participants across the United States, Europe, Asia, and Latin America.

Is VVD-133214 FDA approved?

VVD-133214 is not approved. It is an investigational small molecule still in clinical development, currently in Phase 2 testing for colorectal adenocarcinoma. The only registered study, NCT07811193, has not yet begun recruiting, so the drug remains under investigation and is not available as an approved therapy.

How is the VVD-133214 trial designed?

NCT07811193 is a randomized, active-controlled Phase 2 trial comparing VVD-133214 plus pembrolizumab against pembrolizumab alone in adults with advanced colorectal adenocarcinoma. It is not double blinded, plans to enroll 140 participants, and includes biomarker-selected patients. Participants must be 18 years or older, and the study is not yet recruiting.