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CR011-vcMMAE

Phase 1

Breast Cancer | Small molecule | Oncology |Celldex Therapeutics, Inc.|Trials Updated: Feb 19, 2015

CR011-vcMMAE development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Dec 2006

CR011-vcMMAE target and mechanism

Molecular targetGPNMB
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment159

FDA Designations

No designations recorded

CR011-vcMMAE clinical trials

CR011-vcMMAE · 2 trials · 2 indications

Phase 1 2
NCT00704158Study of CR011-vcMMAE to Treat Locally Advanced or Metastatic Breast CancerBreast Cancer
COMPLETED42 Analytics
NCT00412828A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV MelanomaUnresectable Stage III or Stage IV Melanoma
COMPLETED117 Analytics
PHASE1COMPLETED
Study of CR011-vcMMAE to Treat Locally Advanced or Metastatic Breast Cancer
Breast CancerUnlock trial analytics
PHASE1COMPLETED
A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma
Unresectable Stage III or Stage IV MelanomaUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the safety and tolerability of CR011-vcMMAE in breast cancer patients
throughout the study
To determine the MTD of CR011-vcMMAE in breast cancer patients
throughout the study
to evaluate the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT)
throughout the study

Secondary Endpoints

Evaluation of efficacy (progression-free survival rate at 12 weeks, objective response rate, time to response, duration of response and time to progression)
throughout the study
to evaluate the immune response to CR011-vcMMAE
throughout the study
to assess the pharmacodynamics and pharmacokinetics of CRO11-vcMMAE
throughout the study
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
CR011-vcMMAEDRUGadministered as an intravenous infusion on Day 1 of a 21 day cycle.
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites5

Main Inclusion Criteria: * Females with confirmed breast cancer * Age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2 * Locally advanced or metastatic disease who have received at least two prior chemotherapeutic regimens for breast cancer, as follows: * At least...

Countries:United States
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Competitive Landscape -Breast Cancer 609 trials

Frequently asked questions about CR011-vcMMAE

What is CR011-vcMMAE used for?

CR011-vcMMAE was studied for the treatment of breast cancer and for unresectable Stage III or Stage IV melanoma. It is an oncology therapeutic candidate developed by Celldex Therapeutics. Both indications were evaluated in early-stage clinical trials that have since been completed.

What does CR011-vcMMAE target?

CR011-vcMMAE targets GPNMB, a protein also known as glycoprotein non-metastatic melanoma protein B. By binding to GPNMB, the agent is designed to deliver a cytotoxic payload to cells expressing this target. GPNMB is the molecular target of this investigational oncology therapy.

Who is developing CR011-vcMMAE?

CR011-vcMMAE is being developed by Celldex Therapeutics, Inc., a biotechnology company whose common stock trades under the ticker symbol CLDX. Celldex conducted the clinical studies of CR011-vcMMAE in breast cancer and melanoma.

What phase is CR011-vcMMAE in?

CR011-vcMMAE is in Phase 1 clinical development. It has been evaluated in Phase 1 trials for breast cancer and melanoma. The studies are completed, and no active trials are currently listed for this candidate.

What clinical trials is CR011-vcMMAE in?

CR011-vcMMAE has been studied in two completed clinical trials: NCT00704158, a Phase 1 study in locally advanced or metastatic breast cancer with 42 participants, and NCT00412828, a Phase 1/2 study in unresectable Stage III or Stage IV melanoma with 117 participants. Both trials were conducted in the United States.