Celcuity has dosed the first subject in the Phase Ib/II CELC-G-201 clinical trial of gedatolisib plus Nubeqa (darolutamide) to treat metastatic castration-resistant prostate cancer (mCRPC).

The trial will assess gedatolisib plus darolutamide in up to 54 participants with mCRPC who have progressed after androgen receptor inhibitor treatment.

During the Phase Ib segment, 36 participants will be randomly assigned to receive 600mg of darolutamide with either 120mg or 180mg of gedatolisib.

An additional 12 participants will be enrolled for the Phase II part to evaluate the recommended Phase II dose (RP2D) of gedatolisib.

Assessing the safety and tolerability of the gedatolisib-darolutamide combination and determining the RP2D of gedatolisib are the primary objectives of the Phase Ib portion.

Measuring radiographic progression-free survival (rPFS) at six months in patients who received treatment at RP2D is the primary goal of the Phase II portion.

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A lead therapeutic candidate of Celcuity, gedatolisib is a reversible dual inhibitor that selectively acts on all Class 1 PI3K isoforms and mTORC1/2.

In August last year, Celcuity signed a clinical trial partnership and supply agreement with Bayer. The latter agreed to provide Nubeqa (darolutamide) to Celcuity at no cost for the Phase Ib/II trial.

Celcuity chief medical officer Igor Gorbatchevsky said: “We are excited to begin enrolling patients in our 201 trial and advancing towards our ultimate goal of providing a transformative therapeutic option for patients with prostate cancer.

“A significant unmet need remains for patients with metastatic castration-resistant prostate cancer who have become resistant to a next-generation androgen receptor inhibitor.”

Celcuity develops targeted therapies to treat multiple solid tumour indications.

Apart from the CELC-G-201 trial, gedatolisib is being assessed in the Phase III VIKTORIA-1 clinical trial along with fulvestrant with or without palbociclib in HR+/HER2- advanced breast cancer patients.

The CELsignia companion diagnostic platform of the company can assess live patient tumour cells to detect new groups of cancer patients who could benefit from priorly approved treatments.