We are pleased to announce that Global Clinical Trials (GCT) has been officially approved by the regulatory authorities as the CRO of record for a Phase Ib oncology clinical trial sponsored by SAPU Nano (US) LLC, a clinical-stage biotechnology company committed to pushing boundaries in cancer treatment research.
This achievement is particularly noteworthy as the study was transferred to GCT from another CRO, requiring an accelerated transition and seamless execution to maintain project timelines. Through close collaboration with the sponsor’s Chief Executive Officer Dr. Vuong Trieu and leadership team, as well as regulatory authorities, GCT secured CRO transition approval approximately three weeks ahead of the planned timeline. “We are proud to have achieved this important milestone alongside SAPU Nano,” said Dr. Eugene Selivra, Chief Executive Officer of Global Clinical Trials. “Securing regulatory approval ahead of schedule demonstrates the strength of our project team and our commitment to delivering efficient trial execution. We look forward to supporting the successful advancement of this promising oncology program.” SAPU Nano Chief Executive Officer Dr. Vuong Trieu added, “This milestone advances our international development strategy for Sapu003 and reinforces the value of working with a CRO partner that brings deep regional regulatory expertise. We look forward to building on this momentum as the program expands across multiple geographies.”
The study is a Phase 1b, open-label, dose-escalation trial evaluating Sapu003, an innovative intravenous formulation of Everolimus (Afinitor(R)), in patients with advanced mTOR-sensitive solid tumors. The trial represents an important step in advancing targeted cancer therapies and may help expand treatment options for patients through improved drug delivery and pharmacological performance.
The regulatory green light represents a critical milestone that enables the next phase of study start-up activities, including import license submission, Local Ethics Committee (LEC) approvals, and other key steps required for successful site initiation.
We are proud of our regulatory and clinical operations teams for delivering this important milestone ahead of schedule and supporting our sponsor’s oncology program. We look forward to advancing this study and contributing to the development of new treatment options for patients with advanced solid tumors.
About SAPU Nano
SAPU Nano is a clinical-stage biotechnology company developing Deciparticle™ nanomedicine therapeutics designed to optimize delivery of hydrophobic oncology agents and peptide-based drugs. The company operates an integrated ISO-5 cGMP manufacturing facility in San Diego supporting rapid advancement from formulation to clinical trial supply, with programs advancing across solid tumors and rare pediatric diseases. For more information, visit www.sapunano.com