Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GM-CSF · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| CEA DNA prime (cohort I) | EXPERIMENTAL | 5 patients, tetwtCEA DNA intradermal delivery with electroporation, not previously vaccinated with CEA66 DNA. Electrical pulses applied to vaccination sites in skin using Derma Vax immediately after DNA administration. One dose of Cyclophosphamide (300 mg/m2) will be given i.v. three days before each vaccination with tetwtCEA DNA. |
| CEA DNA boost (cohort II) | EXPERIMENTAL | 10 patients, tetwtCEA DNA intradermal delivery with electroporation, previously vaccinated with CEA66 DNA.Electrical pulses applied to vaccination sites in skin using Derma Vax immediately after DNA administration.One dose of Cyclophosphamide (300 mg/m2) will be given i.v. three days before each vaccination with tetwtCEA DNA. |
| CEA DNA prime + GM-CSF (cohort III) | EXPERIMENTAL | 5 patients, tetwtCEA DNA intradermal delivery with electroporation + GM-CSF, not previously vaccinated with CEA66 DNA.Electrical pulses applied to vaccination sites in skin using Derma Vax immediately after DNA administration.One dose of Cyclophosphamide (300 mg/m2) will be given i.v. three days before each vaccination with tetwtCEA DNA. |
| Name | Type | Description |
|---|---|---|
| tetwtCEA DNA (wt CEA with tetanus toxoid Th epitope) | BIOLOGICAL | Two vaccinations at week 0 and 12. Intradermal administration of 400ug DNA/dose with electroporation |
| Derma Vax (electroporation device) | DEVICE | Electrical pulses applied to vaccination sites in skin using Derma Vax immediately after DNA administration |
| GM-CSF | BIOLOGICAL | GM-CSF will be given for 4 consecutive days starting the day before the vaccination as an intradermal/subcutaneous administration of 150 ug of GM-CSF |
| Cyclophosphamide | DRUG | One intravenous dose of 300 mg/m2 will be given three days before each vaccination with tetwtCEA DNA |
Inclusion Criteria: * Histological confirmed AJCC stage II or III colorectal cancer * Resection of the primary tumour without evidence of remaining macroscopic disease * Allowable standard chemotherapy or radiotherapy in AJCC stage III completed minimum 2 months prior study entry * Patients recruit...
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GM-CSF is a monoclonal antibody being studied for the treatment of colorectal cancer. It is currently in Phase 1 clinical development as an investigational therapy. The drug is being evaluated in a clinical trial that has been completed, with the goal of assessing its safety in patients with colorectal cancer.
GM-CSF is being developed by Pulse Biosciences, Inc, a company traded on the stock exchange under the ticker symbol PLSE. The company is conducting clinical research on this monoclonal antibody for the treatment of colorectal cancer, with the drug currently in Phase 1 development.
GM-CSF is in Phase 1 clinical development for the treatment of colorectal cancer. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 1 trial for GM-CSF has been completed, and the drug remains in early-stage clinical development.
GM-CSF has been studied in one clinical trial with the identifier NCT01064375. This trial was a Phase 1 study titled 'Safety Study of DNA Vaccine Delivered by Intradermal Electroporation to Treat Colorectal Cancer.' The study enrolled 16 participants with colorectal cancer and was conducted in Sweden. The trial has been completed.
Yes, GM-CSF is a monoclonal antibody. It is being developed as a therapeutic for colorectal cancer. As a monoclonal antibody, it is designed to target specific proteins involved in disease processes. The drug is currently in Phase 1 clinical development and is being studied for its safety in patients with colorectal cancer.