Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PRGN-2009 · 1 trial · 5 indications
The ORR will be calculated as the combination of subjects achieving a complete response or a partial response per RECIST v1.1. ORR will be calculated and presented with 2-sided 95% confidence interval.
| Arm | Type | Description |
|---|---|---|
| PRGN-2009 plus Pembrolizumab | EXPERIMENTAL | PRGN-2009 at a dose of 5 x 10\^11 PU q3W for 3 administrations, then q6w, plus Pembrolizumab, 400mg q6w |
| Name | Type | Description |
|---|---|---|
| PRGN-2009 plus Pembrolizumab | BIOLOGICAL | Subjects randomized will receive PRGN-2009 (5 x 10\^11 PU, subcutaneous (SC) injection) every 3 weeks for three administrations, thereafter subjects will continue to receive PRGN-2009 administrations every 6 weeks. Pembrolizumab will be administered concurrently as intravenous (IV) infusion (400 mg) every 6 weeks. |
Inclusion Criteria: * Age 18 years and older. * Recurrent or metastatic cervical cancer (histologically or cytologically confirmed) * Must have been treated with pembrolizumab, either as monotherapy or in combination, for atleast 6 weeks. * Subjects must have histologically or cytologically confirm...
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PRGN-2009 is being studied for the treatment of cervical cancer, including recurrent and metastatic cervical carcinoma and other HPV-related cancers. It is given in combination with pembrolizumab in an ongoing Phase 2 clinical trial. It is an investigational therapy and has not been approved for commercial use.
PRGN-2009 targets HPV, the human papillomavirus, which is the viral target class for this agent. By directing activity against HPV, the therapy is designed for HPV-related malignancies such as cervical cancer. It is being evaluated in combination with pembrolizumab in patients with recurrent or metastatic cervical cancer.
PRGN-2009 is being developed by Precigen, Inc., which trades on the Nasdaq under the ticker PGEN. The company is the sponsor of the ongoing clinical program evaluating the agent in HPV-related cancers, including cervical cancer. The lead study combines PRGN-2009 with pembrolizumab.
PRGN-2009 is in Phase 2 clinical development. The single registered trial for this agent is a Phase 2 study, and it is currently recruiting participants. PRGN-2009 is investigational and has not been approved by the FDA for any indication.
PRGN-2009 is being studied in one clinical trial, NCT06157151, titled PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer. The Phase 2 study is recruiting and plans to enroll 24 participants in the United States. It is an uncontrolled trial open to patients aged 18 years and older.