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IMP9064

Phase 1

Solid Tumor | Small molecule | Oncology |cbdMD, Inc.|Last Updated: Apr 1, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment61

FDA Designations

No designations recorded

Clinical trial landscape

IMP9064 · 1 trial · 2 indications

Phase 1 1
NCT05269316Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid TumorsSolid Tumor
RECRUITING61 Analytics
PHASE1RECRUITING
Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid Tumors
Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse events (Safety and Tolerability)
11 months

Safety and tolerability as determined by the incidence of adverse events (AEs), including severe AEs and serious AEs (SAEs)

To determine the Maximum Tolerable Dose
11 months

Maximum Tolerable Dose (if any)/Recommended Phase 2 Dose of IMP9064 monotherapy

Secondary Endpoints

To determine Maximum concentration (Cmax)
11 months
To determine area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-t)
11 months
To assess Overall response rate (ORR)
11 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IMP9064 MonotherapyEXPERIMENTALDose-escalation IMP9064 administered orally on empty stomach once/twice daily

Interventions

NameTypeDescription
IMP9064DRUGIMP9064 Monotherapy administered for 21 days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: 1. Patients ≥ 18 years of age on the day of signing informed consent form (ICF) (at the time of screening for Part 1 and Part 2C and pre-screening for Part 2A and Part 2B). 2. Must voluntarily participate in the study and be willing and able to provide signed informed consent wh...

Countries:United StatesAustraliaChinaTaiwan
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumor")

Frequently asked questions about IMP9064

What is IMP9064 used for?

IMP9064 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development as a monotherapy or in combination for patients with advanced solid tumors.

Who is developing IMP9064?

IMP9064 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker YCBD. The drug is currently in Phase 1 clinical trials for advanced solid tumors.

What phase is IMP9064 in?

IMP9064 is in Phase 1 clinical development. It is an investigational drug being studied in a Phase 1 trial for advanced solid tumors, and it has not yet been approved by regulatory authorities.

What clinical trials is IMP9064 in?

IMP9064 is being evaluated in a Phase 1 clinical trial with the identifier NCT05269316. This trial is recruiting patients with advanced solid tumors and is being conducted in the United States, Australia, China, and Taiwan.

Is IMP9064 being studied as a monotherapy or in combination?

IMP9064 is being studied both as a monotherapy and in combination with other agents in a Phase 1 clinical trial for advanced solid tumors. The trial is uncontrolled and is enrolling approximately 61 patients aged 18 years and older.