Alteogen said that its antibody-drug conjugate (ADC) ALT-P7 for patients with HER2-positive advanced breast cancer has proved safety and efficacy in phase 1 clinical trial.
The study results were released at the online poster session of the American Society of Clinical Oncology (ASCO) 2020. Alteogen’s phase 1 trial was the first-in-human study conducted on 24 to 48 patients to determine the maximum tolerated dose (MTD), and it evaluated the safety of ALT-P7.
According to the study results, ALT-P7 was well tolerated in patients up to a dose of 4.5 milligrams per kilogram in heavily pretreated patients. However, dose-limiting toxicity (DLT) was found in three patients who received 4.8 milligrams per kilogram of the treatment.
HER2-positive metastatic breast cancer patients tested positive for a protein called human epidermal growth factor receptor 2, promoting the growth of cancer cells. One of every five patients has cancer cells that have extra copies of the gene to make HER2 protein. HER2-positive breast cancers tend to be more aggressive than other breast cancer.
The MTD was determined to be 4.5 milligrams per kilogram and confirmed as the recommended dose for phase 2 trials.
The disease control rate (DCR) of ALT-P7 was 72 percent, and the median progression-free survival (PFS) at a dose from 2.4 to 4.8 milligrams per kilogram was 6.2 months. The study showed dose-dependent pharmacokinetics of ALT-P7.
In the cohort of 27 patients, the most common grade three and four adverse events (AE) was neutropenia, while other treatment-related AEs were mostly grade one and two.
“ALT-P7 is a drug-conjugated anticancer medicine that confirmed the safety and efficacy in phase 1 clinical trials. We expect it to show excellent efficacy at phase 2 trial with the recommended dose,” Alteogen said.
Alteogen plans to evaluate further the efficacy of ALT-P7 in phase 2 and also will assess applicability for other various solid carcinomas, including gastric, urothelial, or biliary tract cancers, it added.
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