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BT02

Phase 1

Advanced Melanoma | Small molecule | Oncology |cbdMD, Inc.|Last Updated: Aug 6, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment58

FDA Designations

No designations recorded

Clinical trial landscape

BT02 · 1 trial · 2 indications

Phase 1 1
NCT07107178A Clinical Study of BT02 for the Treatment of Patients With Advanced Malignant MelanomaAdvanced Melanoma
NOT YET_RECRUITING58 Analytics
PHASE1NOT YET_RECRUITING
A Clinical Study of BT02 for the Treatment of Patients With Advanced Malignant Melanoma
Advanced MelanomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse events
Through the study completion, an average of 2 years
Dose limited toxicity(DLT)
Through the dose escalation phase, an average of 8 months
Maximum tolerable dose(MTD)
Through the dose escalation phase, an average of 8 months
Recommended phase 2 dose(RP2D)
Through the study completion, an average of 2 years

Secondary Endpoints

Objective response rate (ORR) on tumor assessments
Through the study completion, an average of 2 years
Progression-free survival (PFS) on tumor assessments
Through the study completion, an average of 2 years
Overall survival (OS)
Through the study completion, an average of 2 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
dose escalation and expansionEXPERIMENTAL -

Interventions

NameTypeDescription
BT02DRUGmonoclonal antibody injection with intravenous administration every 2 or 3 weeks
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: 1. Patients with histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic malignant melanoma (except for uveal melanoma) who have failed in the prior systemic therapy . 2. Adequate organ and hematologic function. 3. At least 1 extracrani...

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Frequently asked questions about BT02

What is BT02 used for?

BT02 is an investigational small molecule being developed for the treatment of advanced melanoma. It is currently in Phase 1 clinical development, with a study targeting patients with advanced malignant melanoma and advanced solid tumors. The drug is not yet approved and remains in clinical trials.

Who makes BT02?

BT02 is being developed by cbdMD, Inc., a company traded under the ticker YCBD. The company is conducting a Phase 1 clinical trial of BT02 for advanced melanoma. As of the latest information, the drug is in early-stage clinical development and has not received regulatory approval.

What phase is BT02 in?

BT02 is in Phase 1 clinical development. It is being studied in an open-label, uncontrolled trial for patients with advanced melanoma and advanced solid tumors. The drug is investigational and has not been approved by regulatory authorities. The Phase 1 trial is not yet recruiting participants.

What clinical trials is BT02 in?

BT02 is being evaluated in a Phase 1 clinical trial with the identifier NCT07107178. This study, titled "A Clinical Study of BT02 for the Treatment of Patients With Advanced Malignant Melanoma," is designed to enroll 58 participants aged 18 years and older. The trial is not yet recruiting and is uncontrolled.

How does BT02 work?

BT02 is a small molecule therapeutic being developed for oncology indications. Its specific molecular target has not been disclosed in available information. The drug is currently in Phase 1 clinical trials for advanced melanoma, where its safety and preliminary efficacy are being evaluated.