The study of the XPO1 inhibitor for solid tumors aims to accrue 48 patients.
The first patient has been dosed in the phase 1b/2 REACH study pf ATG-016 (eltanexor) as a monotherapy for advanced solid tumors, including those with genetic mutations or viral association, according to a press release by Antengene Corporation Limited.
ATG-016 is a next generation XPO1 inhibitor. It is a selective inhibitor of nuclear export (SINE) compound that is designed to have an improved pharmacological profile and reduced brain penetration over previous SINE compounds.
"The REACH study is designed to evaluate the safety, pharmacokinetics and preliminary efficacy of ATG-016/eltanexor [KPT-8602] monotherapy in patients with progressive or resistant disease, building on promising, published Phase I results. With 70% of cancer patients remaining as non-responders or progressing after initial response, Antengene has prioritized the development of treatments for advanced or resistant cancers," said Kevin Lynch, MD Antengene's chief medical officer, in a press release. "We remain grateful to all of the healthcare professionals, scientists, patients, and families involved with Antengene's clinical studies.”
The REACH study (NCT05010525) has a target enrollment of 48 participants and an estimated completion date of December 2026. Primary end points include maximum tolerated dose, recommended phase 2 dose, adverse events, and overall response rate. Secondary end points include disease control rate, duration of response, and overall survival.
During the study, 4 dose levels will be tested: 20 mg, 35 mg, 50mg, and 65 mg. Treatment cycles will be 21 days, with an initial dose of 1 to 5 times a week. ATG-016 will be administered orally.
In order to participate in the study, patients must be 18 years of age or older, have a life expectancy of at least 12 weeks, an ECOG performance status of 0 or 1, and have at least 1 measurable lesion. Additionally, in order to participate in phase 2, patients must have a confirmed diagnosis of penile squamous cell carcinoma or nasopharyngeal carcinoma.
Patients with central nervous system metastases, a history of bone or organ transplantation, prior ATG-016 administration, have received radiation within 28 days of the study, have a history of HIV, another primary malignancy, active bleeding within 6 months, or clinically significant cardiovascular disease are not eligible to participate.
"The opening of the REACH trial is a very important milestone for Antengene. As the second study of ATG-016 to be conducted in mainland China, it highlights our approach of running our own, complementary, additional studies in China on partnered products," said Jay Mei, MD, PhD, founder and chief executive officer of Antengene, in a press release. "Furthermore, this study underscores Antengene's commitment to focusing our clinical development efforts on diseases that are particularly prevalent in China versus the United States.”