The first three patients have been dosed in a clinical trial evaluating the safety and tolerability of MILGa, a radioactive antibody designed to seek out and destroy cancerous tumors in advanced prostate, bladder, and pancreatic cancer.
The patients — two with pancreatic cancer and one with prostate cancer — have completed a one-month follow-up, and no treatment-related side effects were reported, according to a press release from the treatment’s developer, Minomic International.
This first-in-human trial (ACTRN12616000787482) — which is being conducted after successful preclinical studies — is primarily examining the safety, tolerability and tumor-targeting ability of a chimeric version of Minomic’s MIL-38 monoclonal antibody conjugated with the radioactive isotope 67-Gallium (MILGa). The single-arm trial is being conducted at Macquarie University’s private hospital in Sydney, Australia.
MILGa will be evaluated based on several parameters: patients’ vital signs, 12-lead electrocardiograms (ECGs) and blood draws, biomarker blood draws, an analysis of patients’ urine, hematology and biochemistry blood analysis, and physical examinations.
Secondary endpoints include evaluating MILGa as a diagnostic tool in prostate, bladder, and pancreatic tumors, and analyzing tumor images to determine how much MILGa accumulates in different organs.
In preclinical studies, MILGa successfully targeted prostate, pancreatic, and bladder cancer cells. The experiments, which were conducted in mouse models, also showed that the treatment was well-tolerated and especially suited for prostate cancer.
The non-randomized clinical trial will enroll as many as 12 patients to confirm MILGa’s ability to accurately target tumors in patients with two to 15 cancer metastases. Participants must be at least 18 years old and have stable or slowly progressing disease. The trial is open to men and women.
“The results from this trial will provide us with important safety data as well as telling us how well the antibody targets different tumour types,” Brad Walsh, PhD, Minomic’s chief executive officer, said in the press release. “We will use this information to guide the future development of the drug. The initial findings for the first three patients are very encouraging.”
“There are no approved antibody therapies for prostate or pancreatic cancer, whilst bladder cancer remains extremely expensive to treat,” he said. “There is therefore the potential for major advances in the treatment of these cancers”