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VVD-133214

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |cbdMD, Inc.|Last Updated: Aug 17, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment280

FDA Designations

No designations recorded

Clinical trial landscape

VVD-133214 · 1 trial · 2 indications

Phase 1 1
NCT06004245A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of VVD-133214 as Monotherapy and in Combination in Participants With Advanced Solid TumorsAdvanced Solid Tumors
RECRUITING280 Analytics
PHASE1RECRUITING
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
Advanced Solid Tumors
NCT06004245280
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Study Endpoints

Primary Endpoints

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)
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
Incidence of Dose-Limiting Toxicities
Cycle 1 (1 cycle is 3 weeks)

Secondary Endpoints

Maximum Plasma Concentration Observed (Cmax) of VVD-133214
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)
Time of Maximum Plasma Concentration Observed (Tmax) of VVD-133214
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)
Area Under the Plasma Concentration-Time Curve (AUC) of VVD-133214
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)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
VVD-133214 Dose EscalationEXPERIMENTAL -
VVD-133214 Monotherapy ExpansionEXPERIMENTAL -
VVD-133214 + Pembrolizumab ExpansionEXPERIMENTAL -
VVD-133214 + Bevacizumab ExpansionEXPERIMENTAL -

Interventions

NameTypeDescription
VVD-133214DRUGVVD-133214 will be administered orally and once daily (QD) in 3-week cycles.
PembrolizumabDRUGPembrolizumab will be administered by intravenous (IV) infusion at a fixed dose of 200 mg on Day 1 of each 21-day cycle.
BevacizumabDRUGBevacizumab will be administered by intravenous (IV) infusion at a fixed dose of 7.5 mg/kg on Day 1 of each 21-day cycle.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites43

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...

Countries:United StatesAustraliaBelgiumCanadaChinaDenmarkFranceMalaysiaSouth KoreaSpainUnited Kingdom
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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