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news.Nektar Therapeutics have dosed first patient in a new Phase 1 dose-escalation clinical study to evaluate its oncology compound, NKTR-102, in combination with 5-fluorouracil (5-FU)/leucovorin in refractory solid tumor cancers.
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Nektar said that the study is being conducted at University Hospitals Case Medical Center of the Case Comprehensive Cancer Center in Cleveland, Ohio.
NKTR-102 is a novel topoisomerase I inhibitor-polymer conjugate with a sustained exposure profile and a macromolecular structure that targets tumor tissue through the enhanced permeation and retention (EPR) effect.
The Phase 1 study of NKTR-102 is expected to assess the safety, pharmacokinetics and anti-tumor activity of the anti-cancer agent when given in combination with standard doses of 5-FU/leucovorin.
Lorianne Masuoka, senior vice president and chief medical officer of Nektar, said: “The dosing of the first patients in this combination study marks another important milestone in the strategic development of NKTR-102.
“The new Phase 1 study complements our continuing Phase 2 study in second-line colorectal cancer which is evaluating NKTR-102 as a single-agent as compared to irinotecan in patients possessing the KRAS gene mutation.
“Based upon the markedly enhanced activity of NKTR-102 over irinotecan in preclinical models of gastrointestinal cancer and its notable activity in Phase 2 clinical testing in breast and ovarian cancers, we believe NKTR-102 is a promising new anti-cancer agent that has the potential to provide an important treatment option for patients with the deadliest forms of colon and rectal cancers.”