NAPISTAR 1-01
Research type
Research Study
Full title
A multicenter, first-in-human, dose escalation and optimization phase I/IIa study to investigate safety, tolerability, pharmacokinetics, and efficacy of the NaPi2b antibody-drug conjugate TUB-040 in patients with platinum-resistant high-grade ovarian cancer (PROC) or relapsed/refractory adenocarcinoma non-small cell lung cancer (NSCLC).
IRAS ID
1009697
Contact name
Mary Ann Lumiqued
Contact email
Sponsor organisation
Tubulis GmbH
ISRCTN Number
NA
Clinicaltrials.gov Identifier
Research summary
This study is known as first-in human study using new drug (TUB-040) in two phases for patients with either advanced ovarian or non-small cell lung cancer. Patients with these tumors have abnormally high levels of a certain protein (called NAPi2b) on the surface of their tumor cells. TUB-040 is a dual-action medicine: one part (the antibody) aims to find all cells that have this protein on their surface, and the second part (the payload) aims to kill the cancer cells after it has been transferred inside the cell. It is hoped that TUB-040 will target the tumor more specifically and cause less damage to healthy cells than some other cancer treatments. There will be 8-15 sites involved across UK, Spain, Belgium, Germany and USA. The study is planned to run for 2 years.
This study will proceed in two phases:
Phase 1: Finding the Safe Dose - Dose Escalation Phase: This way, they find the highest dose that mostly everyone can tolerate comfortably, always prioritizing at patient's safety. Patients with ovarian cancer will start the treatment first and then non-small cell lung cancer will start the next.
Phase 2: Fine-Tuning for Optimal Results – Dose Optimization: Based on the results of the dose escalation phase, patient's are randomly allocated by computer to receive one of two or more promising doses of TUB-040.
During the whole treatment, patients will have to visit the site at the time of screening and also for the intravenous injection with TUB-040 every 3 weeks until disease is progressed or improved. The patients may have the slow progression of cancer or chances to again achieve long lasting tumour remission but it has not been proven yet. The patient will receive individual and close monitoring by the doctor beyond the usual care. The study doctor will talk to the patients regularly about whether it is best to carry on getting the study treatment or stop. A dose escalation board (DEB) will oversee the study and make sure it’s conducted safely.REC name
South Central - Berkshire Research Ethics Committee
REC reference
24/SC/0266
Date of REC Opinion
20 Sep 2024
REC opinion
Further Information Favourable Opinion