Actively Recruiting
FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC
Led by Tubulis GmbH · Updated on 2026-03-03
250
Participants Needed
15
Research Sites
181 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or non-pregnant, non-breastfeeding female aged 18 years or older at consent
- Disease not treatable with curative intent
- Exhausted standard of care treatments with expected survival benefit
- Measurable disease by RECIST 1.1 with at least 1 lesion not previously irradiated
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Life expectancy greater than 12 weeks
- Willing to sign tissue release form for biomarker research
- Willing to undergo non-contrast high-resolution CT of the thorax and pulmonary function testing at screening
- Adequate organ function
- Resolution of acute toxic effects from prior therapies to grade 1 or less (except certain stable conditions)
- Sexually active females of childbearing potential must use highly effective contraception or true abstinence during and after treatment
- Able to understand and comply with study procedures and provide written informed consent
- No history of non-compliance or unreliability
- Willing to sign informed consent form
You will not qualify if you...
- Pregnant, breastfeeding, or positive pregnancy test at screening
- Hypersensitivity to exatecan, TUB-040 components, or related ADCs
- Disease resistant to topoisomerase-I inhibitors (progression during or within 6 months of last infusion)
- Participation in other interventional clinical studies within 28 days or five half-lives of investigational agents
- Spinal cord compression or active central nervous system disease
- Radiotherapy within 2 weeks prior to trial inclusion
- Major surgery within 21 days prior to consent unless recovered
- History or current interstitial lung disease, pneumonitis, or radiation pneumonitis requiring steroids
- Oxygen saturation below 93% on room air at rest
- Forced vital capacity below 60% or lung diffusion capacity below 70%
- QTcF interval over 470 ms
- History of nephrotic syndrome
- Active or recent corneal disease within 12 months
- Uncontrolled severe impairments of major organ systems that increase treatment risk
- Other malignancies not disease-free or treated within past 2 years (exceptions apply)
- Unstable or uncontrolled heart disease or recent myocardial infarction
- Concurrent chemotherapy, radiotherapy (except local), immunotherapy, or corticosteroids
- Live vaccines within 30 days prior to study entry
- Active infections not controlled or severe/recurrent infections or history of progressive multifocal leukoencephalopathy
- HIV infection not well controlled on therapy or active unresolved infection(s)
AI-Screening
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Trial Site Locations
Total: 15 locations
1
The University of Alabama
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Mount Sinai
New York, New York, United States, 10011
Actively Recruiting
3
Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
4
Ohio State University
Columbus, Ohio, United States, 43210#
Actively Recruiting
5
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
6
Next Oncology Dallas
Irving, Texas, United States, 75039
Actively Recruiting
7
Next Oncology Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
8
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
9
Charité Universitätsmedizin Berlin
Berlin, Germany, 10117
Actively Recruiting
10
University Hospital Cologne Department of Internal Medicine I
Cologne, Germany, 50937
Actively Recruiting
11
Arensia Exploratory Medicine
Cluj-Napoca, Romania
Actively Recruiting
12
Clínica universidad de Navarra
Madrid, Spain, 28027
Actively Recruiting
13
NEXT Oncology Madrid
Madrid, Spain, 28223
Actively Recruiting
14
Arensia Exploratory Medicine
Kyiv, Ukraine
Actively Recruiting
15
Guy's Hospital
London, United Kingdom, SE1 9RT
Actively Recruiting
Research Team
T
Tubulis Clinical Trial Inquiries
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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