🚀 We’re excited to announce that Global Clinical Trials (GCT) has been selected to take over and lead a new early-stage oncology clinical study following a competitive CRO evaluation and selection process. To enrich the Sponsor’s decision, we shared contacts and references from previous and existing international clients which are readily available for unbiased evaluation of GCT performance.
The study is a Phase 1b, open-label, dose-escalation trial evaluating the safety, tolerability, and pharmacokinetics of IMP in patients with advanced mTOR-sensitive solid tumors. The outcomes of this trial will be critical in defining the optimal dose and shaping further product development. We sincerely thank the Sponsor for their trust and look forward to building a strong, long-term partnership potentially bringing us towards global Phase 3 study and improving outcomes for patients in need.
As early as preparing for the bid-defense, GCT BD and Operational Teams created a step-by-step action item plan with detailed timelines to ensure accurate delegation of responsibilities and seamless CRO transition upon Work Order signature. Our teams are already fully engaged, with pre-study and transition activities actively underway. We are proud of reaching the first milestone – completing the regulatory submission for CRO change – in less than 14 business days, 2 weeks ahead of schedule.
GCT depot has been selected for a wide range of logistics activities for the project, including IMP storage at +2+8°C, ancillary supplies and biosamples management.