An investigational therapy called LY3143921 hydrate will be tested for the first time in a large Phase 1 clinical trial for patients with advanced cancers, including ovarian cancer.
The trial (NCT03096054) will be conducted at four centers in the United Kingdom under the supervision of the Cancer Research UK (CRUK) Centre for Drug Development (CDD).
In preclinical studies with mice, LY3143921 hydrate showed potential in cancer by selectively inhibiting the Cdc7 protein, which helps cells divide correctly. Cancer cells divide more rapidly than normal cells, forcing them to depend greatly on Cdc7. This makes them more susceptible to drugs that inhibit the protein’s activity.
Now, Eli Lilly‘s drug candidate will be tested in cancer patients for the first time.
In the first phase of the study, researchers will assess the drug’s safety and efficacy in several cancers, including advanced bowel, lung, ovarian, urothelial (those that can affect bladder, ureters, and renal pelvis), pancreatic, breast, head and neck, and esophageal cancer.
Increasing doses of LY3143921 hydrate will be administered to patients so that researchers can determine the dose that most effectively targets cancer cells without causing harm.
In the trial’s second part, large groups of patients will receive the most effective dose of the drug and researchers will investigate the therapy’s mode of action. The drug will be delivered once daily over 21 days. The treatment will be repeated up to 12 times, but if a patient is benefiting, they may continue to receive the drug.
“We hope that this new cancer drug might — in the future — provide patients who have tried all available treatment options another opportunity to stop their cancer cells from multiplying and control their disease,” Prof. Richard Wilson, a Cancer Research UK-funded clinical researcher and chief investigator at the Northern Ireland Cancer Centre, said in a press release.
Researchers think that cancers with a faulty p53 gene, one of the major tumor suppressor genes, may show a particular susceptibility to inhibition of Cdc7, and so the study will also focus particularly on cancers with a high rate of p53 mutations. These include high grade serous ovarian cancer, metastatic bowel cancer, and squamous non-small cell lung cancer (NSCLC).
“It’s very early days, but this trial will help us to understand whether this drug could help cancer patients and whether it has the potential to stop the growth of many different cancer types, particularly those with loss of p53 function,” Wilson added.
“Finding new ways to tackle hard-to-treat cancers is a crucially important area of research and a priority for Cancer Research UK,” said Dr. Nigel Blackburn, Cancer Research UK’s director for drug development.
“At our Centre for Drug Development, we work across the academic, pharmaceutical, and biotechnology sectors to bring much-needed new treatments to cancer patients,” he said. “New drugs like this one to treat advanced types of cancer are vital to ensure three in four people survive their disease by 2035.”
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