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SM04755

Phase 1

Colorectal Cancer | Small molecule | Oncology |cbdMD, Inc.|Last Updated: Sep 7, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment13

FDA Designations

No designations recorded

Clinical trial landscape

SM04755 · 1 trial · 4 indications

Phase 1 1
NCT02191761Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic CancerColorectal Cancer
COMPLETED13 Analytics
PHASE1COMPLETED
Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic Cancer
Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Determine the MTD
28 days

Secondary Endpoints

Incidence of safety parameters including adverse events, laboratory results, vital signs, electrocardiogram (ECG) findings, Eastern Cooperative Oncology Group (ECOG) performance scores, physical and ophthalmic examination findings
28 days
Area under the plasma concentration (AUC) Versus Time Curve of SM04755
30 days
Characterize the pharmacodynamics (PD) of SM04755 by assessment of its preliminary antitumor activity determined by Response Evaluation Criteria in Solid Tumors (RECIST)
8 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SM04755EXPERIMENTAL -

Interventions

NameTypeDescription
SM04755DRUGEscalating Doses
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Subjects with advanced colorectal, gastric, hepatic or pancreatic cancer * Subjects must have recovered from all toxicity associated with previous chemotherapy, targeted therapy, or radiotherapy * Subjects must meet certain laboratory criteria * Expected survival \> 3months * ...

Countries:United States
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Frequently asked questions about SM04755

What is SM04755 used for?

SM04755 is an investigational small molecule being studied for the treatment of advanced colorectal cancer, as well as gastric, hepatic, and pancreatic cancers. It is in Phase 1 clinical development and has not been approved by the FDA.

Who makes SM04755?

SM04755 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 development for oncology indications.

What phase is SM04755 in?

SM04755 is in Phase 1 clinical development. It has completed one Phase 1 trial and is not yet approved by the FDA. The drug remains investigational and is being evaluated for safety and pharmacokinetics in patients with advanced cancers.

What clinical trials is SM04755 in?

SM04755 has been studied in one completed Phase 1 trial, NCT02191761, titled 'Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic Cancer.' The trial enrolled 13 participants in the United States and was not randomized or blinded.

What does SM04755 target?

SM04755 is a small molecule being developed for oncology. Its specific molecular target has not been disclosed in available information, so its mechanism of action is not described here.