FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC
Recruiting now · Phase 1/Phase 2
Conditions studied: Ovarian Cancer, Non-small Cell Lung Cancer
In brief
The purpose of this multicentric, open label trial (NAPISTAR 1-01) is to evaluate the safety/tolerability, pharmacokinetics and preliminary efficacy of TUB-040 and to find the best dose of TUB-040 in patients with ovarian cancer and Non Small Cell Lung Cancer. TUB-040 is an antibody-drug-conjugate which delivers a topoisomerase I inhibitor to tumor cells which overexpress the target NaPi2b. The study consists of two parts: In dose escalation, ovarian cancer patients and lung cancer patients receive increasing doses of TUB-040 until the maximal tolerated dose is found. In dose optimization, at least two doses are compared with each other to determine which dose is optimal for patients. TUB-040 is given IV every 3 weeks until the disease progresses or the patient has to stop due to side effects.
Key facts
- Study ID
- NCT06303505
- Run by
- Tubulis GmbH
- People needed
- 250
- Starts
- 2024-06-12
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-05-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- The University of Alabama — Birmingham, Alabama, United States (enrolling)
- Mount Sinai — New York, New York, United States (enrolling)
- Christ Hospital — Cincinnati, Ohio, United States (enrolling)
- Ohio State University — Columbus, Ohio, United States (enrolling)
- OU Health Stephenson Cancer Center — Oklahoma City, Oklahoma, United States (enrolling)
- Next Oncology Dallas — Irving, Texas, United States (enrolling)
- Next Oncology Virginia — Fairfax, Virginia, United States (enrolling)
- UZ Leuven — Leuven, Belgium, Belgium (enrolling)
- Charité Universitätsmedizin Berlin — Berlin, Germany (enrolling)
- University Hospital Cologne Department of Internal Medicine I — Cologne, Germany (enrolling)
- Arensia Exploratory Medicine — Cluj-Napoca, Romania (enrolling)
- Clínica universidad de Navarra — Madrid, Spain (enrolling)
- NEXT Oncology Madrid — Madrid, Spain (enrolling)
- Arensia Exploratory Medicine — Kyiv, Ukraine (enrolling)
- Guy's Hospital — London, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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