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AVZO-1418

Phase 1

Solid Tumor Cancer | Small molecule | Oncology |cbdMD, Inc.|Last Updated: Aug 28, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment480

FDA Designations

No designations recorded

Clinical trial landscape

AVZO-1418 · 1 trial · 8 indications

Phase 1 1
NCT07038343AVENTINE-1: Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001)Solid Tumor Cancer
RECRUITING480 Analytics
PHASE1RECRUITING
AVENTINE-1: Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001)
Solid Tumor Cancer
NCT07038343480
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Study Endpoints

Primary Endpoints

Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1)
Approximately 2 years

Number of participants with DLTs assessed for severity using CTCAE v5.0 criteria will be summarized by dose level.

Determine the maximum tolerated dose (MTD) and/or preliminary recommended Phase 2 dose (RP2D) (Phase 1)
Approximately 16 months
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 1)
From baseline until end of study treatment or study completion (approximately 2 years)
Objective Response Rate (ORR) (Phase 2)
From baseline through disease progression or study completion (approximately 2 years)

Defined as the proportion of patients with a confirmed Complete Response (CR) or Partial Response (PR), as determined by the investigator by radiographic disease assessment according to RECIST v1.1.

Secondary Endpoints

Objective Response Rate (ORR) (Phase 1)
From baseline through disease progression or study completion (approximately 2 years)
Duration of Response (DOR) (Phase 1 and 2)
From baseline through disease progression or study completion (approximately 2 years)
Disease Control Rate (DCR) (Phase 1 and 2)
From baseline through disease progression or study completion (approximately 2 years)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 1, monotherapyEXPERIMENTALGroup A
Phase 1, combinationEXPERIMENTALGroup B
Phase 2, monotherapyEXPERIMENTALPart A
Phase 2, combinationEXPERIMENTALPart B

Interventions

NameTypeDescription
AVZO-1418DRUGSpecific dose in protocol specified schedule
Combination Agent 1DRUGPer label based on combination agent used
Combination Agent 2DRUGPer label based on combination agent used
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites19

Key Inclusion Criteria * Patient must be an adult, between 18 and 75 years of age with an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 and a life expectancy of \> 3 months. * Patients with histologically or cytologically confirmed locally advanced/metastatic malignancies for ...

Countries:United States
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