Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pelareorep · 1 trial · 5 indications
Defined as the percentage of participants having an objective response (complete response \[CR\] or partial response \[PR\]), according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The ORR of the drug will be assessed according to Simon's two stage design. The estimated ORR will be compared to the response rate specified in the null hypothesis (6%) using one-sided exact binomial test at type I error 5%. 95% confidence interval (C.I.) will be also reported.
Will be determined by the number, frequency, duration, and severity of adverse events (AEs) using Common Terminology Criteria for Adverse Events (CTCAE) v 5.0; laboratory tests and vital signs.
| Arm | Type | Description |
|---|---|---|
| Treatment (pelareorep, retifanlimab) | EXPERIMENTAL | Patients receive pelareorep IV over 60 minutes on days 1, 2, 15, and 16. Patients also receive INCMGA00012 IV over 60 minutes on day 3. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Pelareorep | BIOLOGICAL | Given IV |
| Quality-of-Life Assessment | OTHER | Ancillary studies |
| Questionnaire Administration | OTHER | Ancillary studies |
| Retifanlimab | BIOLOGICAL | Given IV |
Inclusion Criteria: * Metastatic or inoperable locally advanced, histologically documented triple negative breast cancer (TNBC) (negative expression of estrogen receptor \[ER\], progesterone receptor \[PR\] and human epidermal growth factor receptor 2 \[HER2\] immunohistochemistry \[IHC\] 0 or 1+, ...
Pelareorep is an investigational monoclonal antibody being studied for the treatment of metastatic triple-negative breast cancer, including anatomic stage IV breast cancer AJCC v8. It is currently in Phase 2 clinical development for this indication.
Pelareorep is a monoclonal antibody, but its specific molecular target has not been disclosed in the available information. It is being studied in combination with INCMGA00012 for the treatment of metastatic triple-negative breast cancer.
Pelareorep is being developed by Incyte Corporation, which is listed on the stock exchange under the ticker symbol INCY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with metastatic triple-negative breast cancer.
Pelareorep is currently in Phase 2 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 2 trial is actively recruiting participants, though enrollment is not yet complete.
Pelareorep is being studied in a Phase 2 clinical trial with the identifier NCT04445844, titled 'INCMGA00012 and Pelareorep for the Treatment of Metastatic Triple Negative Breast Cancer, IRENE Study.' This trial is active but not recruiting, with an enrollment of 25 female patients in the United States.
No, Pelareorep and INCMGA00012 are different drugs. They are being studied in combination in the IRENE study for the treatment of metastatic triple-negative breast cancer. Pelareorep is a monoclonal antibody, while INCMGA00012 is a separate investigational agent.