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KSH01

Phase 1

Solid Tumor | Small molecule | Oncology |cbdMD, Inc.|Last Updated: Apr 3, 2023

Target and mechanism

ModalitySmall molecule

Also known as KSH01 injection

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

KSH01 · 1 trial · 1 indication

Early Phase 1 1
NCT05580796KSH01-R02-101 Solid TumorsSolid Tumor
RECRUITING50 Analytics
EARLY_PHASE1RECRUITING
KSH01-R02-101 Solid Tumors
Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants in treatment related adverse events assessed by CTCAE v4.0
about 3 years

To evaluate the safety and tolerance of autologous TCR-T cells in target positive solid tumor subjects.

objective remission rate
about 3 years

To preliminarily evaluate the objective remission rate of autologous TCR-T cells in the treatment of target positive solid tumor subjects (such as esophageal cancer, gastric cancer, head and neck cancer, bladder cancer, melanoma, sarcoma, etc.).

Secondary Endpoints

Maximum tolerable dose values
about 3 years
Changes in tumor size and time.
about 5 years
Concentration of pharmacokinetic values in plasma
about 3 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TCR-T cellsEXPERIMENTALTCR-T cell injection

Interventions

NameTypeDescription
KSH01 injectionDRUGTCR-T cell injection
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 1\) Voluntary participation in clinical research; Fully understand the study and voluntarily sign the informed consent form; Willing to follow and able to complete all test procedures; * 2\) Male or female, 18 to 70 years old (including boundary value); * 3\) Malignant solid t...

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

Frequently asked questions about KSH01

What is KSH01 used for?

KSH01 is an investigational small molecule being developed for the treatment of solid tumors. It is currently in Phase 1 clinical development and is being studied in patients with solid tumors. The drug is administered as an injection.

Who makes KSH01?

KSH01 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The company is conducting clinical trials for this investigational oncology drug.

What phase is KSH01 in?

KSH01 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to evaluate its safety and efficacy in patients with solid tumors.

What clinical trials is KSH01 in?

KSH01 is being studied in a Phase 1 clinical trial with the identifier NCT05580796, titled 'KSH01-R02-101 Solid Tumors'. This trial is currently recruiting participants in China and aims to enroll 50 patients with solid tumors.

Is KSH01 the same as KSH01 injection?

Yes, KSH01 is also known as KSH01 injection. The drug is administered as an injectable formulation, and both names refer to the same investigational oncology drug being developed for solid tumors.