Taivex announced that T-1101 has received approval from the U.S. Food and Drug Administration (FDA) to advance to Phase II clinical trials. This trial will further evaluate the safety and efficacy of T-1101 in patients with neuroendocrine tumors (NET), laying a solid foundation for future regulatory submissions.
T-1101 is the first-in-class oral small-molecule inhibitor targeting Hec1/Nek2, developed to treat advanced, refractory solid tumors and provide patients with an innovative therapeutic option.
In Phase I clinical trials, T-1101 demonstrated promising safety and preliminary efficacy results, strengthening confidence in its further development. The Phase II trial will be conducted at multiple clinical research centers worldwide.
Taivex will continue to work closely with clinical trial partners and regulatory authorities to ensure the successful progress of the trial and remain committed to offering innovative treatment options for cancer patients.