KEY TAKEAWAYS
- NCT01631552 IMMU-132-01 is a Phase I/II study that evaluated the efficacy and safety of the drug Sacituzumab Govitecan-hziy (SG), also known as IMMU-132 (hRS7-SN38 Antibody Drug Conjugate).
- In this four-arm study, participants were administered varying doses of SG ranging from 8 mg/kg to 18 mg/kg via IV until disease progression or unacceptable toxicity.
- The study’s primary outcome measures were varying degrees of AEs and the ORR by ICR and Local Assessment.
- The study was clinically significant in prolonging OS and reducing tumor growth in vivo.
In the Phase II IMMU-132-01 clinical trial, Sacituzumab Govitecan was found to be effective and tolerable in individuals with advanced epithelial cancers. This study aimed at ascertaining the bioavailability of Sacituzumab Govitecan (SG) in breast-brain metastasis and glioblastoma.
By measuring the levels of free SN-38, SN-38G, and total SN38 in tumor tissue, serum, and CSF, it was possible to determine how well SG can cross the blood-brain barrier and reach tumor cells. Patients were enrolled in a single-center clinical phase 0 trial to receive a single intravenous dose of SG at 10 mg/kg one day before surgical resection if they had been diagnosed with brain metastatic breast cancer and recurrent glioblastoma.
During surgery, samples of the tumor and the matching serum were taken to check the levels of SN-38 and its metabolites. After regaining health, patients restarted SG treatment at 10 mg/kg on days 1 and 8 of 21-day cycles. In every third cycle, responses were evaluated by MRI using the RANO criteria. Total Sn-38 concentrations were measured in tumor tissue and matching patient serum. IHC was used to examine the expression of Trop-2 and CAIX. In a rodent model of intracranial breast cancer, SG activity was examined.
Total SN-38 was measured in the patient samples at an average concentration of 2365 ng/ml in blood and 132 ng/g in tissue. 90% of patient tumors exhibited Trop-2 expression. 40% of the samples displayed strong CAIX expression. SG greatly prolonged overall survival and reduced tumor growth in vivo. According to RANO criteria, 20% of patients in the trial’s breast cancer arm showed a full response, while the other 80% showed a partial response.
The final survival rates for participants in the breast cancer metastasis arm were 80%. After tumor resection surgery, sacituzumab govitecan, an effective medication that penetrates the blood-brain barrier, can prevent the spread of metastatic breast cancer to the brain.
Source: https://www.sabcs.org/Portals/SABCS2016/2022%20SABCS/Tuesday.pdf
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT01631552
Ghamasaee, P., Balinda, H., Brenner, A., & Floyd, J. (2022, October 10). P1-14-04 A Phase 0 Clinical trial of Sacituzumab Govitecan in Patients with Breast Cancer Brain Metastases and Recurrent Glioblastoma. SABCS, 646. https://www.sabcs.org/Portals/SABCS2016/2022%20SABCS/Tuesday.pdf
