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Context Therapeutics, Menarini Group Collaborate on Phase I/II Breast Cancer Combo Trial

NEW YORK – Context Therapeutics and the Menarini Group on Tuesday announced a clinical trial collaboration to study Context's onapristone with Menarini's elacestrant in estrogen receptor (ER)-positive, progesterone receptor (PR)-positive, HER2-negative metastatic breast cancer.

The combination of onapristone, a progesterone receptor antagonist, and elacestrant, an estrogen receptor degrader, will be studied in the Phase Ib/II ELONA trial. The trial will enroll metastatic breast cancer patients who have been previously treated with a CDK4/6 inhibitor.

The trial will be sponsored by Context, and Menarini Group will provide elacestrant at no cost. Context expects to begin the trial in the fourth quarter of this year.

Context, based in Philadelphia, is also studying onapristone, or ONA-XR, in combination with letrozole and Pfizer's Ibrance (palbociclib) in first-line ER-positive, PR-positive, HER2-negative metastatic breast cancer; in combination with endocrine therapy as a second-line treatment for the same patient population; and in PR-positive ovarian and endometrial cancer.

Elacestrant is also being studied by Menarini Group, and its partner Radius Health, as a monotherapy in a Phase III trial for ER-positive, HER2-negative advanced or metastatic breast cancer patients. In June, Menarini and Radius submitted a new drug application to the US Food and Drug Administration for elacestrant as a treatment for patients with ER-positive, HER2-negative advanced or metastatic breast cancer.