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Resiquimod

Phase 1

Advanced Malignancies | Monoclonal antibody | Oncology |Celldex Therapeutics, Inc.|Last Updated: Jun 27, 2016

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment70

FDA Designations

No designations recorded

Clinical trial landscape

Resiquimod · 1 trial · 1 indication

Phase 1 1
NCT00948961A Study of CDX-1401 in Patients With Malignancies Known to Express NY-ESO-1Advanced Malignancies
COMPLETED70 Analytics
PHASE1COMPLETED
A Study of CDX-1401 in Patients With Malignancies Known to Express NY-ESO-1
Advanced MalignanciesUnlock trial analytics

Study Endpoints

Primary Endpoints

Occurrence of adverse events (side effects)
12 weeks (1 cycle of study treatment)

Secondary Endpoints

Objective response rate (CR/PR), disease control rate (CR/PR/SD) and time to progression, based on disease-appropriate response criteria.
12 week intervals
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
CDX-1401 in combination with Resiquimod and/or Poly-ICLCBIOLOGICALCDX-1401 is administered as an injection into the skin every 2 weeks for 4 doses. It is given in combination with Resiquimod and/or poly-ICLC. Resiquimod is administered as a topical gel applied to the skin or given as an injection under the skin, and poly-ICLC is given as an injection under the skin. Depending on the treatment group assignment, either one or both of the immune stimulants will be given on the day of and the day after CDX-1401 administrations. This treatment may be repeated every 12 weeks.
CDX-1401BIOLOGICAL -
ResiquimodBIOLOGICAL -
poly-ICLCBIOLOGICAL -
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Eligibility Criteria

Age Range18 Years to 99 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: Among other criteria, patients must meet all of the following conditions to be eligible to be in the study: 1. 18 years of age or older. 2. Have a cancer type that is known to express NY-ESO-1, including (but not limited to) cancer of the bladder, breast, ovary, non-small cell ...

Countries:United States
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Frequently asked questions about Resiquimod

What is Resiquimod?

Resiquimod is an investigational drug being developed by Celldex Therapeutics, Inc. (CLDX) for the treatment of advanced malignancies. It is currently in Phase 1 clinical development. As of the available data, it has completed one clinical trial with a total enrollment of 70 participants.

What is Resiquimod used for?

Resiquimod is being studied for use in advanced malignancies, which are cancers that have spread or are difficult to treat. It is an investigational oncology drug, meaning it is not yet approved for any use and is still undergoing clinical evaluation to determine its safety and effectiveness.

Who makes Resiquimod?

Resiquimod is being developed by Celldex Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CLDX. The company is conducting clinical research to evaluate the drug's potential in treating advanced malignancies.

What phase is Resiquimod in?

Resiquimod is currently in Phase 1 clinical development. This is the earliest stage of testing in humans, primarily focused on assessing the drug's safety, tolerability, and dosing. It is not yet approved by regulatory authorities and remains an investigational agent.

What clinical trials is Resiquimod in?

Resiquimod has been studied in one completed clinical trial, identified as NCT00948961. This Phase 1 trial, titled 'A Study of CDX-1401 in Patients With Malignancies Known to Express NY-ESO-1,' enrolled 70 participants with advanced malignancies in the United States. The trial was not randomized or blinded and had no control group.

Is Resiquimod the same as CDX-1401?

Yes, Resiquimod is also known as CDX-1401. The completed clinical trial NCT00948961, which studied the drug in patients with advanced malignancies, used the name CDX-1401 in its title. This alternative name is used interchangeably in clinical research contexts.