08:46 AM EDT, 05/30/2024 (MT Newswires) -- Celcuity ( CELC ) said Thursday it plans to launch a phase 3 clinical trial to evaluate gedatolisib in combination with other drugs as a first-line treatment for patients with HR+/HER2- advanced breast cancer who are resistant to endocrine therapy.

The combination includes either ribociclib or palbociclib, both cyclin-dependent kinase inhibitors, along with fulvestrant. About 638 patients at up to 200 clinical sites worldwide will be involved in the open-label, randomized trial, with enrollment set to begin in Q2 2025, according to the company. The primary endpoint is progression-free survival as assessed by an independent review body.

In connection with the study, the oncology-focused clinical-stage biotech said it amended its debt financing agreement with an affiliate of Innovatus Capital Partners to receive an additional term loan of $61.7 million for a total debt outstanding of $100 million.

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