Curium Group, PeptiDream and PDRadiopharma Enroll First Patient to Registrational Clinical Trial of Lu-PSMA-I&T for Prostate Cancer in Japan

• A Registrational Phase 2 clinical trial has been initiated in Japan for patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).

Excerpt from the Press Release:

BOSTON, Feb. 04, 2026 (GLOBE NEWSWIRE) — Curium Group today announced that together with PeptiDream Inc. and PDRadiopharma Inc., the first patient has been dosed in the companies’ registrational clinical trial of ¹⁷⁷Lu-PSMA-I&T in Japan for patients with PSMA (*1)-positive metastatic castration-resistant prostate cancer (mCRPC).

¹⁷⁷Lu-PSMA-I&T is a radiotherapeutic agent targeting PSMA conjugated to a chelator radiolabeled with Lutetium-177. The multicenter, open-label, single-arm registrational Phase 2 trial will evaluate efficacy and safety of ¹⁷⁷Lu-PSMA-I&T. The trial will enroll patients who have been diagnosed with mCRPC and will be conducted as a registrational trial in Japan, utilizing the bridging data from Curium’s ongoing global clinical trials under the strategic collaboration between PDRadiopharma and Curium.

As announced on 15 October 2025, Curium Group, PeptiDream and PDRadiopharma initiated the clinical trial of ⁶⁴Cu-PSMA-I&T which is being assessed as a diagnostic PET imaging agent with patients who have been newly diagnosed with prostate cancer (please refer to “PeptiDream, PDRadiopharma and Curium Group Enroll First Patient to Registrational Clinical Trial of 64Cu-PSMA-I&T for Prostate Cancer in Japan”). ⁶⁴Cu-PSMA-I&T is also used in this trial to confirm PSMA positivity before the administration of ¹⁷⁷Lu-PSMA-I&T.

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