FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18 lat lub więcej
- •Nowotwór nie nadający się do leczenia z zamiarem wyleczenia
- •Pacjent wyczerpał standardowe leczenie dostępne dla tej choroby
- •Widoczne guzy w badaniach obrazowych (co najmniej jeden wcześniej nie napromieniowany)
- •Dobry stan ogólny (ECOG 0-1)
- •Spodziewana długość życia ponad 12 tygodni
- •Chęć pobrania tkanki do badań naukowych
- •Wola wykonania badań pulmologicznych i tomografii płuc
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 17, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (16)
The University of Alabama
Birmingham, United States
Mount Sinai
New York, United States
Christ Hospital
Cincinnati, United States
Ohio State University
Columbus, United States
OU Health Stephenson Cancer Center
Oklahoma City, United States
Next Oncology Dallas
Irving, United States
START Mountain Region
West Valley City, United States
Next Oncology Virginia
Fairfax, United States
UZ Leuven
Leuven, Belgium
Charité Universitätsmedizin Berlin
Berlin, Germany
University Hospital Cologne Department of Internal Medicine I
Cologne, Germany
Arensia Exploratory Medicine
Cluj-Napoca, Romania
Clínica universidad de Navarra
Madrid, Spain
NEXT Oncology Madrid
Madrid, Spain
Arensia Exploratory Medicine
Kyiv, Ukraine
Guy's Hospital
London, United Kingdom
Trial contact
Tubulis Clinical Trial Inquiries
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/18/2026.
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