Progress in SECuRE Trial: First Patient Receives Treatment in Phase II Expansion

SECuRE Trial Update

The SECuRE trial has marked an important milestone with the treatment of its first participant in the Cohort Expansion Phase (Phase II). This trial, focused on improving treatment outcomes for prostate cancer patients, has seen the administration of an 8 GBq dose of 67Cu-SAR-bisPSMA. The introduction of this new phase follows a successful Dose Escalation Phase and a recommendation from the Safety Review Committee (SRC).

Background of the SECuRE Trial

The SECuRE trial (NCT04868604) explores the use of 67Cu-SAR-bisPSMA, a radiopharmaceutical developed by Clarity Pharmaceuticals, to treat patients with metastatic castration-resistant prostate cancer (mCRPC). The trial aims to determine the safety and efficacy of this targeted therapy by selecting participants exhibiting PSMA-expressing lesions. With a multi-centre, single-arm approach involving approximately 54 patients across the US and Australia, the SECuRE trial is positioned as a beacon of hope for many facing prostate cancer.

Key Developments

The first patient treated received not just the 8 GBq dose of 67Cu-SAR-bisPSMA, but also enzalutamide, an androgen receptor pathway inhibitor. This combination therapy is part of a recent protocol amendment approved to include additional participants, increasing the cohort size from 14 to 24. These amendments reflect the trial's adaptability to integrate findings from related studies, such as the promising results seen in the Enza-p trial conducted by key opinion leaders in prostate cancer treatment.

Prior to this phase, Clarity Pharmaceuticals enhanced the formulation of 67Cu-SAR-bisPSMA, enabling improved stability at room temperature—a crucial factor for large-scale production and distribution.

Positive Safety Profile

The treatment inspiration stems from the favorable safety profile and encouraging efficacy observed during the earlier dosing phases. In the Dose Escalation Phase, significant reductions in prostate-specific antigen (PSA) levels were demonstrated: 92% of pre-chemotherapy participants experienced over a 35% drop in PSA levels, while over 61% recorded a drop greater than 50%. Such efficacy is noteworthy, especially considering the trial's patients often enter with considerable disease burden.

Future Aspirations

Dr. Alan Taylor, Executive Chairperson at Clarity, expressed optimism about the SECuRE trial's trajectory. He emphasizes that these advancements not only aim to bring 67Cu-SAR-bisPSMA to earlier lines of prostate cancer therapy but also explore the benefits of combination therapy that leverages existing insights and research advancements.

The SECuRE trial advocates for improved treatment outcomes, targeting pre-chemotherapy settings where significant benefits have already been observed. The trial continues to work closely with medical experts, ensuring that it incorporates the latest findings into its protocol to maximize clinical trial success and enhance patient outcomes.

Conclusion

With the SECuRE trial now advancing into the Cohort Expansion Phase, there remains an air of anticipation within the medical community. The commitment to providing timely treatment options, robust data collection, and the efficiency of improved formulation sets the foundation for Clarity Pharmaceuticals' ongoing efforts in the fight against prostate cancer. As the trial progresses, it not only marks a significant achievement for Clarity but also offers hope for many patients worldwide facing the challenges of this prevalent disease. For more updates on the SECuRE trial, stay tuned to developments from Clarity Pharmaceuticals.