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CR011-vcMMAE

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

Clinical trial landscape

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 402 trials

Top 20 of 92 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, Capivasertib, Fulvestrant
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen, goserelin
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Frequently asked questions about CR011-vcMMAE

What is CR011-vcMMAE used for?

CR011-vcMMAE is an investigational small molecule being studied for the treatment of unresectable Stage III or Stage IV melanoma and breast cancer. It is in Phase 1 clinical development and is not yet approved by the FDA.

Who makes CR011-vcMMAE?

CR011-vcMMAE is being developed by Celldex Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker CLDX. The drug is currently in Phase 1 clinical trials for oncology indications.

What phase is CR011-vcMMAE in?

CR011-vcMMAE is in Phase 1 clinical development. It has completed two Phase 1 trials, one in unresectable Stage III or Stage IV melanoma and one in breast cancer. The drug remains investigational and is not FDA approved.

What clinical trials is CR011-vcMMAE in?

CR011-vcMMAE has been studied in two completed Phase 1 trials. NCT00412828 enrolled 117 participants with unresectable Stage III or Stage IV melanoma in the United States. NCT00704158 enrolled 42 female participants with breast cancer in the United States.

Is CR011-vcMMAE the same as glembatumumab vedotin?

CR011-vcMMAE is also known as glembatumumab vedotin. It is an antibody-drug conjugate targeting glycoprotein NMB, which is expressed in certain cancers. The drug is being developed by Celldex Therapeutics for melanoma and breast cancer.