Selvion Receives Phase 3 IND Approval for Prostate Cancer Treatment 177Lu-DGUL

Phase 3 Clinical Trial Approved in Korea for Metastatic Castration-Resistant Prostate Cancer
Pivotal Multicenter Study to Enroll 150 Patients
Randomized 1:1 Assignment to Experimental and Control Groups

Selvion, a company specializing in radiopharmaceuticals, announced on the 29th that it has received approval from the Ministry of Food and Drug Safety for its Phase 3 clinical trial plan (IND) of 177Lu-DGUL (Forquebotide Satetetraxetan) for patients with metastatic castration-resistant prostate cancer (mCRPC).

Selvion applied for approval of the Phase 3 clinical trial plan in June. With this approval, the company plans to officially begin the Phase 3 clinical trial at multiple institutions nationwide. This pivotal trial aims to evaluate the efficacy and safety of 177Lu-DGUL and to confirm its therapeutic effects based on results obtained from previous clinical development stages.

Selvyup company logo image. Selbion

177Lu-DGUL is a radiopharmaceutical candidate targeting the prostate-specific membrane antigen (PSMA). Selvion is advancing clinical development to provide a new treatment option for patients with metastatic castration-resistant prostate cancer.

The clinical trial will enroll a total of 150 participants, who will be randomly assigned in a 1:1 ratio to either the experimental group or the control group. The experimental group will receive a combination of best supportive care/standard of care (BSC/SoC) with 177Lu-DGUL, while the control group will receive BSC/SoC alone. The study will compare the efficacy and safety between the two groups to evaluate the therapeutic effects of 177Lu-DGUL.

A representative from Selvion stated, "This approval of the Phase 3 clinical trial plan is an important step toward clearly establishing the clinical value of 177Lu-DGUL. We will do our utmost to conduct future clinical trials without delay, systematically verify its efficacy and safety, and provide a new treatment option for patients with metastatic castration-resistant prostate cancer."

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