Clinical Trials
Novel Approach
Most drugs, including for the treatment of cancer, are not able to enter the brain because of the blood-brain barrier. Learn more about the blood-brain barrier and the LRP-directed peptide-drug conjugate approach to targeting tumors in the brain.
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GRN1005 Against Brain Metastases from Breast Cancer (GRABM-B)
Helpful Information
- Whole Brain Radiation Therapy is commonly used to irradiate visible tumors in the brain along with very small tumor deposits which are often undetectable.
- The intracranial response rate is the percentage of patients whose cancer inside the brain shrinks or disappears after treatment.
- Duration of intracranial response is the length of time of the response inside the brain.
- Progression-free survival (PFS) is the length of time during and after treatment in which the cancer does not get worse.
A Phase 2, Multi-Center, Open-Label Study Evaluating GRN1005 Alone or in Combination with Trastuzumab in Breast Cancer Patients with Brain Metastases
Geron is conducting a clinical trial to evaluate the effect of our product candidate, GRN1005, in patients whose breast cancer has metastasized to the brain. This study is open to patients with HER2+ and HER2- metastatic breast cancer who may or may not have had prior Whole Brain Radiation Therapy (WBRT).
In this Phase 2 clinical trial, our clinical investigators and researchers are evaluating how GRN1005 may affect the intra-cranial response rates of patients when used alone or in combination with trastuzumab, a commonly used treatment for HER2+ breast cancer outside of the brain.
In addition to understanding the impact GRN1005 has on metastases in the brain, we will determine the duration of intra-cranial response and obtain data on three-month intra-cranial progression free survival (PFS).
GRN1005 is an investigational treatment for cancer in development by Geron and has not been approved by the FDA or any other regulatory agency.
About GRN1005
Most drugs, including for the treatment of cancer, are not able to enter the brain because of the blood-brain barrier (BBB). This presents a challenge for treating cancer in the brain. GRN1005 is designed to deliver paclitaxel, an effective anti-cancer agent, across the BBB and into brain tumors by exploiting a native mechanism by which essential substances (e.g., lipids and hormones), successfully enter the brain. Learn more
Cancer Definitions
To learn more about the terms and definitions used in cancer clinical studies you may find the National Cancer Institute Dictionary of Cancer Terms a useful resource.
Para obtener más información acerca de los términos y las definiciones utilizadas en los estudios clínicos sobre el cáncer es posible que el Instituto Nacional del Cáncer Diccionario de cáncer en un recurso útil.
How to Participate
To learn more about how to participate in this clinical trial, please visit ClinicalTrials.gov for the full trial summary and enrollment criteria.
Additionally, patients or their physicians may directly contact the nearest trial center for more information about how to participate. The study is currently being conducted in multiple trial centers across the United States.
Novel Approach
Most drugs, including for the treatment of cancer, are not able to enter the brain because of the blood-brain barrier. Learn more about the blood-brain barrier and the LRP-directed peptide-drug conjugate approach to targeting tumors in the brain.
Learn more
