Fusion has dosed the first patient with FPI-2265 under P-II part of the P-II/III (AlphaBreak) study for metastatic castration-resistant prostate cancer (mCRPC). The company anticipates the completion of patient recruitment (n=~60) in the P-II part by the end of 2024
The P-II/III (AlphaBreak) study assesses the safety & efficacy of FPI-2265 in mCRPC patients who previously received 177Lu-PSMA radiotherapy. The P-II part aims at assessing 2 alternative dosing regimens’ safety & efficacy vs previous dosing of 100 kBq/kg Q8W.
The company further plans to enroll ~500 participants and the initiation of P-III global registration part of the study in 2025 post-determination of recommended P-III dosing regimen from the P-II part
Ref: AstraZeneca | Image: AstraZeneca
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