Related Experiment Video
Updated: Mar 16, 2026
A Syngeneic Mouse Model of Metastatic Renal Cell Carcinoma for Quantitative and Longitudinal Assessment of Preclinical Therapies
Published on: April 12, 2017
First-in-Human Phase 1 Trial of Agarose Beads Containing Murine RENCA Cells in Advanced Solid Tumors
Barry H Smith1, Tapan Parikh1, Zoe P Andrada1
1The Rogosin Institute, Cancer Research, New York, NY, USA.
Purpose:
Agarose macrobeads containing mouse renal adenocarcinoma cells (RMBs) release factors, suppressing the growth of cancer cells and prolonging survival in spontaneous or induced tumor animals, mediated, in part, by increased levels of myocyte-enhancing factor (MEF2D) via EGFR-and AKT-signaling pathways. The primary objective of this study was to determine the safety of RMBs in advanced, treatment-resistant metastatic cancers, and then its efficacy (survival), which is the secondary objective.
Methods:
Thirty-one patients underwent up to four intraperitoneal implantations of RMBs (8 or 16 macrobeads/kg) via laparoscopy in this single-arm trial (FDA BB-IND 10091; NCT 00283075). Serial physical examinations, laboratory testing, and PET-CT imaging were performed before and three months after each implant.
Results:
RMBs were well tolerated at both dose levels (mean 660.9 per implant). AEs were (Grade 1/2) with no treatment-related SAEs.
Conclusion:
The data support the safety of RMB therapy in advanced-malignancy patients, and the preliminary evidence for their potential efficacy is encouraging. A Phase 2 efficacy trial is ongoing.
Insights
Mouse renal adenocarcinoma cells (RMBs) show promise in treating advanced cancers. This study found RMB therapy to be safe and potentially effective in patients with treatment-resistant metastatic cancers.
Area of Science:
- Oncology
- Cancer Cell Biology
- Immunotherapy
Background:
- Mouse renal adenocarcinoma cells (RMBs) secrete factors that inhibit cancer cell proliferation and extend survival in animal models.
- These effects are partially mediated by myocyte-enhancing factor (MEF2D) through EGFR and AKT signaling pathways.
Purpose of the Study:
- To evaluate the safety of RMB therapy in patients with advanced, treatment-resistant metastatic cancers.
- To assess the preliminary efficacy, specifically survival, of RMBs as a secondary objective.
Main Methods:
- A single-arm clinical trial involving 31 patients with advanced cancers.
- Patients received up to four intraperitoneal implantations of RMBs (8 or 16 macrobeads/kg) via laparoscopy.
- Safety and efficacy were monitored through physical examinations, laboratory tests, and PET-CT imaging.
Main Results:
- RMBs were well-tolerated in patients at both tested dose levels.
- Adverse events were primarily Grade 1/2, with no treatment-related serious adverse events observed.
Conclusions:
- RMB therapy demonstrates a favorable safety profile in patients with advanced malignancies.
- Preliminary data suggest encouraging potential efficacy, warranting further investigation in a Phase 2 trial.
