The first patents were administered in clinical trials evaluating new treatments for breast cancer and other solid tumors.
Work is underway in a Phase 1/2 trial evaluating STX-478 — an oral agent that penetrates the central nervous system (CNS) and can inhibit mutant phosphoinositide-3-kinase alpha (PI3Kα). According to his May 2 news release from the manufacturer, Scorpion Therapeutics, Inc., he is being tested for monotherapy and Includes combination therapy with approved drugs. New drug behind
About 160 participants, all aged 18 or older and with advanced solid tumors, began the study in April. It aims to evaluate the safety, tolerability, pharmacokinetics (the drug’s activity in the body) and preliminary anti-tumor activity of STX-478 and is expected to be completed by June 2026.
According to a statement from Scorpion, the study seeks to determine the safety profile of STX-478 and establish the maximum tolerated dose and, if indicated, the lower biologically effective dose. Combination agents in breast cancer and other solid tumor types and PI3Kα mutated HR+/HER-2− breast cancer.
Subsequently, Scorpion plans to evaluate STX-478 as monotherapy in patients with PI3Kα-mutant solid tumors, including breast, gynecologic, HNSCC and gastrointestinal cancers. Secondary study objectives include assessment of pharmacokinetic profile, pharmacodynamic efficacy (how it works in the body), and clinical response.
STX-478, described by Scorpion in a press release, is designed for patent on tumors characterized by common PI3Kα mutations found in more than 166,000 breast, gynecologic, and head and neck cancer patients in the United States each year. increase.
According to a news release, current treatments for PI3Kα-mutant cancers inhibit normal or wild-type PI3Kα in healthy tissues and can cause side effects such as hyperglycemia (hyperglycemia) and rashes. Duration tolerance of treatment. “Despite the fact that up to 50% of all solid tumor patients develop significant morbidity and mortality from brain metastases,” said Scorpion, “there is little or no CNS penetrance.” .
“STX-478 is a wild-type, central nervous system-penetrating, oral inhibitor of mutant PI3Kα with excellent preclinical pharmacokinetic properties,” said Michael, Chief Medical Officer, Scorpion. Dr. Streit said in a news release. “This Phase 1/2 trial aims to demonstrate how these key attributes translate into a potentially superior product profile that offers a broader therapeutic window and greater efficacy. increase.
“We plan to publish the first safety, pharmacokinetic and pharmacodynamic results in 2024, including data on the effects of STX-478 on potential biomarkers suggestive of anti-tumor activity. We believe it differentiates STX-478 from existing agents currently on the market or in development and supports its safe and highly differentiated therapeutic profile in the treatment of solid tumors, particularly HR+/HER2- breast cancer. We look forward to working with researchers to evaluate STX-478 in patients with PI3Kα-mutant cancers.”
For the latest cancer information, research and education news, don’t forget to subscribe to the CURE® newsletter here..