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ONT-10, Varlilumab combination

Phase 1

Advanced Breast Carcinoma | Monoclonal antibody | Oncology |Celldex Therapeutics, Inc.|Last Updated: May 17, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment22

FDA Designations

No designations recorded

Clinical trial landscape

ONT-10, Varlilumab combination · 1 trial · 2 indications

Phase 1 1
NCT02270372Study of ONT-10 and Varlilumab to Treat Advanced Ovarian or Breast CancerAdvanced Breast Carcinoma
COMPLETED22 Analytics
PHASE1COMPLETED
Study of ONT-10 and Varlilumab to Treat Advanced Ovarian or Breast Cancer
Advanced Breast Carcinoma
NCT0227037222
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Study Endpoints

Primary Endpoints

Number of participants with adverse events as a measure of safety and tolerability
Cycles of 12 weeks

Assessment of the adverse event profile as an indication of overall safety and tolerability of the combination treatment with ONT-10 and varlilumab

Secondary Endpoints

Immune Response to MUC1
8 weeks on a weekly basis, followed by every 6 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Drug CombinationEXPERIMENTALThe drug combination of ONT-10 and varilumab

Interventions

NameTypeDescription
ONT-10, Varlilumab combinationBIOLOGICALONT-10 a liposomal synthetic glycopolypeptide MUC1 targeted antigen formulated with PET Lipid A adjuvant. Varlilumab is a recombinant, fully human mAb of the IgG1κ isotype that specifically binds human CD27.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. Be at least 18 years of age at the time of consent 2. Life expectancy of at least 6 months, in the opinion of the investigator 3. Have histologically confirmed breast or ovarian carcinoma 4. Have evidence of persistent, recurrent, or progressive disease for which there is no ...

Countries:United States
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Frequently asked questions about ONT-10, Varlilumab combination

What is ONT-10, Varlilumab combination used for?

ONT-10, Varlilumab combination is used for advanced breast carcinoma. It is a monoclonal antibody combination being developed by Celldex Therapeutics, Inc. (CLDX) for the treatment of advanced breast carcinoma. The combination is currently in Phase 1 clinical development.

Who makes ONT-10, Varlilumab combination?

Celldex Therapeutics, Inc. (CLDX) is developing ONT-10, Varlilumab combination. The company is conducting clinical trials for this monoclonal antibody combination in advanced breast carcinoma. The drug is currently in Phase 1 development.

What phase is ONT-10, Varlilumab combination in?

ONT-10, Varlilumab combination is in Phase 1 clinical development. It is an investigational monoclonal antibody combination being studied for advanced breast carcinoma. The drug has completed one Phase 1 trial and is not yet approved by the FDA.

What clinical trials is ONT-10, Varlilumab combination in?

ONT-10, Varlilumab combination has one completed clinical trial, NCT02270372, titled 'Study of ONT-10 and Varlilumab to Treat Advanced Ovarian or Breast Cancer'. This Phase 1 trial enrolled 22 participants with advanced breast or ovarian carcinoma in the United States.

Is ONT-10, Varlilumab combination the same as Varlilumab?

ONT-10, Varlilumab combination is a combination therapy that includes Varlilumab. The clinical trial NCT02270372 studied the combination of ONT-10 and Varlilumab in patients with advanced breast or ovarian cancer. The drug is being developed by Celldex Therapeutics, Inc. (CLDX).