Danish biotech company Adcendo announced on Wednesday that it has received approval from the US Food & Drug Administration (FDA) for its IND application for a Phase I study assessing ADCE-T02 in patients with advanced solid tumours.
Adcendo is conducting a first-in-human Phase I multicentre, open-label, dose escalation study of ADCE-T02, named Tiffany-01, as a monotherapy in patients with advanced solid tumours.
The primary objectives of the study are to determine the maximum tolerated dose and recommended Phase II dose and schedule of ADCE-T02 monotherapy, in addition to assessing ADCE-T02 safety and tolerability. Secondary objectives are to characterise the pharmacokinetics and to evaluate the preliminary efficacy of ADCE-T02.
The study is currently recruiting in Australia and will start recruiting in the United States in the next few months.
Australia declines approval for BioArctic and Eisai's Alzheimer's drug lecanemab
AstraZeneca's Imfinzi recommended for EU approval in resectable NSCLC treatment
Fapon Biopharma's FP008 IND application receives US FDA approval
AbbVie receives positive CHMP opinion for upadacitinib in giant cell arteritis
Avobis Bio LLC receives Fast Track designation from FDA for AVB-114
US FDA grants Priority Review to Sobi's sBLA for Gamifant in Still's disease-related MAS
Adcendo's ADCE-T02 Phase I study IND application receives US FDA approval
LSPedia secures MMCAP Infuse DSCSA Compliance contract
FDA accepts Telix Pharmaceuticals' BLA for Zircaix and grants Priority Review
Sterotherapeutics launches Phase 2 clinical trial of ST-002 for Cushing's Syndrome