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AGS-003

Phase 2

Renal Cell Carcinoma | Monoclonal antibody | Oncology |cbdMD, Inc.|Last Updated: Jul 15, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

AGS-003 · 1 trial · 1 indication

Phase 2 1
NCT00678119Study Testing the Biologic Activity and Safety of a Immunotherapeutic in Patients With Newly Diagnosed Advanced Stage Kidney Cancer in Combination With a Marketed Renal Cell Carcinoma TreatmentRenal Cell Carcinoma
COMPLETED25 Analytics
PHASE2COMPLETED
Study Testing the Biologic Activity and Safety of a Immunotherapeutic in Patients With Newly Diagnosed Advanced Stage Kidney Cancer in Combination With a Marketed Renal Cell Carcinoma Treatment
Renal Cell CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Clinical antitumor activity will be assessed as an objective tumor response as defined by RECIST. Tumor response is documented using standard definitions of CR and must be confirmed no less than 4 weeks after the criteria for response are first met.
24 weeks

Secondary Endpoints

The monitoring of clinical activity, immune response and safety across multiple doses.
24 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1: AGS-003+sunitinibEXPERIMENTALSingle arm study AGS-003 plus sunitinib

Interventions

NameTypeDescription
AGS-003BIOLOGICALDendritic cell Immunotherapeutic
SunitinibDRUGAn approved drug for the treatment of RCC
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: Male and female subjects ≥18 years of age with newly diagnosed advanced stage RCC will be eligible for inclusion in this study if all of the following criteria apply: 1. Newly diagnosed advanced stage RCC. 2. Eligible for unilateral nephrectomy or partial nephrectomy; OR, Has l...

Countries:United StatesCanada
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Frequently asked questions about AGS-003

What is AGS-003 used for?

AGS-003 is an investigational monoclonal antibody being studied for the treatment of Renal Cell Carcinoma, a type of kidney cancer. It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being evaluated in combination with a marketed renal cell carcinoma treatment.

Who makes AGS-003?

AGS-003 is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker symbol YCBD. The company is conducting clinical research to evaluate the safety and biologic activity of this investigational therapy in patients with advanced kidney cancer.

What phase is AGS-003 in?

AGS-003 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received FDA approval and is still being studied in clinical trials. One Phase 2 trial has been completed, and the drug is not currently in any active trials.

What clinical trials is AGS-003 in?

AGS-003 has been studied in one clinical trial with the identifier NCT00678119. This Phase 2 trial, titled 'Study Testing the Biologic Activity and Safety of a Immunotherapeutic in Patients With Newly Diagnosed Advanced Stage Kidney Cancer in Combination With a Marketed Renal Cell Carcinoma Treatment,' was completed and enrolled 25 participants.

Is AGS-003 the same as cbdMD's other products?

AGS-003 is a distinct investigational monoclonal antibody being developed by cbdMD, Inc. for Renal Cell Carcinoma. It is not the same as any other product the company may offer, as it is a biologic drug candidate in clinical development, not a consumer product.