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TNFerade biologic

Phase 1

Head and Neck Cancer | Small molecule | Oncology |Precigen, Inc.|Last Updated: Feb 23, 2012

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials2
Total Enrollment -

FDA Designations

No designations recorded

Clinical trial landscape

TNFerade biologic · 2 trials · 2 indications

Phase 1 2
NCT00496236Radiotherapy, Cetuximab, and Injections of TNFerade™ Biologic for Elderly or Frail Patients With Head and Neck CancerHead and Neck Cancer
COMPLETED- Analytics
NCT00496535A Study of TNFerade™ Biologic With Concomitant Radiotherapy, Fluorouracil, and Hydroxyurea (TNF-FHX) in Patients With Head and Neck CancerHead and Neck Cancer
COMPLETED- Analytics
PHASE1COMPLETED
Radiotherapy, Cetuximab, and Injections of TNFerade™ Biologic for Elderly or Frail Patients With Head and Neck Cancer
Head and Neck CancerUnlock trial analytics
PHASE1COMPLETED
A Study of TNFerade™ Biologic With Concomitant Radiotherapy, Fluorouracil, and Hydroxyurea (TNF-FHX) in Patients With Head and Neck Cancer
Head and Neck CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

The maximum tolerated dose established in the Phase I (dose-finding) portion of the study will be used to assess the investigational drug's ability to enhance clinical outcome. The primary endpoint being locoregional control rate at 24 months.
locoregional control at 24 months

Secondary Endpoints

Locoregional control at 3,6, and 12 months, objective response rate, progression-free survival at 3,6,12, and 24 months, and the rate of distal metastases at 3,6, 12 and 24 months will also be assessed.
Locoregional control at 3, 6 and 12 months, as well as tumor response rate, progression-free survival at 3, 6, 12 and 24 months, and the rate of metastases at 3, 6, 12 and 24 months will also be assessed.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
TNFerade biologicDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Age 70 or older with an ECOG performance status 0-2,or * Patients \> 18 years of age with ECOG performance status of 2 or greater, or * Patients \> 18 years of age unsuitable for concurrent chemotherapy or surgery due to: * Renal failure, or * Severe cardiopulmonary disease, o...

Countries:United States
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Frequently asked questions about TNFerade biologic

What is TNFerade biologic used for in Head and Neck Cancer?

TNFerade biologic is an investigational therapy being studied for the treatment of Head and Neck Cancer. It is administered by injection in combination with radiotherapy and other agents, such as cetuximab or fluorouracil and hydroxyurea, in clinical trials. The drug is currently in Phase 1 clinical development and is not yet approved.

What does TNFerade biologic target?

TNFerade biologic is a gene therapy that delivers the gene for tumor necrosis factor-alpha (TNF-alpha) directly into tumors. TNF-alpha is a cytokine that can induce tumor cell death and enhance the effects of radiation therapy. By producing TNF-alpha locally within the tumor, the therapy aims to increase the anti-tumor response.

Who makes TNFerade biologic?

TNFerade biologic is being developed by Precigen, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol PGEN. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy in patients with Head and Neck Cancer.

What phase is TNFerade biologic in?

TNFerade biologic is in Phase 1 clinical development. Two Phase 1 trials have been completed, both in patients with Head and Neck Cancer. The drug is investigational and has not been approved by regulatory authorities. Its safety and effectiveness are still being evaluated in early-stage clinical studies.

What clinical trials is TNFerade biologic in?

TNFerade biologic has been studied in two completed Phase 1 clinical trials. NCT00496236 evaluated the drug with radiotherapy and cetuximab in elderly or frail patients with Head and Neck Cancer. NCT00496535 studied TNFerade biologic with radiotherapy, fluorouracil, and hydroxyurea in patients with Head and Neck Cancer. Both trials were conducted in the United States.

Is TNFerade biologic the same as TNF-alpha?

TNFerade biologic is not the same as TNF-alpha. It is a gene therapy that encodes the TNF-alpha gene, causing tumor cells to produce TNF-alpha locally. This approach is designed to concentrate the cytokine's anti-tumor effects within the tumor microenvironment, potentially reducing systemic toxicity compared to direct TNF-alpha administration.