On February 5, 2026 Curium Group reported 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).
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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.
Renaud Dehareng, CEO of Curium Group commented: "Conducting these registrational trials, in partnership with PeptiDream and PDRadiopharma, marks a significant milestone in our mission to expand access to cutting-edge radiopharmaceuticals to patients with prostate cancer across Asia. By combining Curium’s global development expertise with PDRadiopharma’s deep local knowledge and infrastructure, we are well-positioned to deliver transformative solutions to patients with prostate cancer in Japan."
Masato Murakami, President of PDRadiopharma & CMO of PeptiDream commented: "We are excited to initiate the development of 177Lu-PSMA-I&T in Japan. Introducing new treatment options is an important part of improving prostate cancer patient care. Together with 64Cu-PSMA-I&T, this program is expected to provide new options to visualize and treat prostate cancer more precisely, helping patients and their physicians make more informed decisions. In collaboration with Curium, PDRadiopharma is committed to bringing these radiopharmaceutical treatments to patients in Japan as safely and as quickly as possible."
About Prostate Cancer
Prostate cancer continues to be widely prevalent in Japan. Annually, there are approximately 90,000 – 100,000 new cases (*2), with patients with metastatic castration-resistant prostate cancer having an overall survival rate of approximately three years in clinical trial settings, and even shorter in the real-world, and there remains a significant unmet medical need for therapies.
*1: PSMA – prostate-specific membrane antigen which is highly expressed on prostate cancer cells
*2: National Cancer Center Japan
Clinical trial progress
Phase 3 ECLIPSE trial – 177Lu-PSMA-I&T, a PSMA-targeting ligand conjugated with the radioisotope Lutetium-177, has been tested by Curium in a global pivotal Phase 3 ECLIPSE trial (ClinicalTrials.gov identifier; NCT05204927). It reported that the primary endpoint was met, demonstrating a statistically significant and clinically meaningful benefit for patients with mCRPC.
Phase 3 trial SOLAR RECUR and SOLAR STAGE – 64Cu-PSMA-I&T trials are being conducted to diagnose biochemical recurrence of prostate cancer (SOLAR RECUR trial, ClinicalTrials.gov identifier NCT06235099) and for men newly diagnosed with unfavorable intermediate to very high-risk prostate cancer, electing to undergo surgery (SOLAR STAGE trial, ClinicalTrials.gov identifier NCT06235151). The first in human Phase 1/2 SOLAR trial met the co-primary endpoints of region-level correct localization rate and patient-level correct detection rate in patients with histologically-proven metastatic prostate cancer.
Partnership Details
Under the terms of the partnership, Curium and PDRadiopharma will jointly collaborate on clinical development activities of 177Lu-PSMA-I&T and 64Cu-PSMA-I&T in Japan, with PDRadiopharma leading regulatory filing, manufacturing, commercialization, and distribution activities in Japan. Curium will continue to lead global development of the two agents and support PDRadiopharma through technology transfer to support the set-up of manufacturing lines in Japan – including a high throughput Copper 64 manufacturing line based on Curium’s proprietary technology.
(Press release, PeptiDream, FEB 5, 2026, View Source [SID1234662465])