Cellavon announced that it has received approval from the Ministry of Food and Drug Safety (MFDS) for its domestic Phase 3 clinical trial plan for 'Lutetium(177Lu) DGUL (Pocubotide Satetracetan)', a treatment for metastatic castration-resistant prostate cancer.

Cellavon submitted the clinical trial plan on June 30 and received approval notification on September 28. The Phase 3 trial will be conducted at multiple institutions in Korea, including Seoul National University Hospital, enrolling 150 patients with metastatic castration-resistant prostate cancer.

The trial is designed as a multicenter, prospective, open-label, randomized, parallel-controlled study. A total of 150 subjects will be randomly assigned 1:1 to an experimental group and a control group, comparing the efficacy and safety of the experimental group receiving 177Lu-DGUL in addition to best supportive care/standard of care (BSC/SoC) against the control group receiving BSC/SoC alone.

177Lu-DGUL will be administered four times at six-week intervals, and patients who meet pre-defined criteria for additional dosing may receive up to six administrations. Control group patients may also switch to 177Lu-DGUL combination therapy after confirmed radiological disease progression, subject to separate consent and eligibility confirmation procedures.

The primary endpoint is comparison of radiographic progression-free survival (rPFS) between the two treatment groups. In addition, tumor response, health-related quality of life, and changes in prostate-specific antigen (PSA) will be assessed, while safety will be evaluated through adverse events, physical examinations, and laboratory tests.

The clinical trial period is approximately 36 months from the Institutional Review Board (IRB) approval date, with an expected completion date of January 31, 2030. However, the trial period and completion date may change depending on subject enrollment status.

Meanwhile, Cellavon explained in a regulatory filing that the probability of a clinical trial drug ultimately receiving drug approval is statistically known to be around 10%. The company stated that the clinical trial and product approval process may yield results below expectations, and that it may accordingly change or abandon its commercialization plans.