FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC
NCT ID: NCT06303505
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
200 participants
INTERVENTIONAL
2024-06-12
2027-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
TUB-040 is given IV every 3 weeks until the disease progresses or the patient has to stop due to side effects.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Platinum resistant ovarian cancer
TUB-040
A complete treatment cycle is defined as 21 calendar days. TUB-040 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle
Non small cell lung cancer-adenocarcinoma
TUB-040
A complete treatment cycle is defined as 21 calendar days. TUB-040 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TUB-040
A complete treatment cycle is defined as 21 calendar days. TUB-040 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Disease not amenable to curative intent treatment.
3. Patients have exhausted the standard of care treatment (SoC) with expected survival benefit and are not denied SoC with expected survival benefit by participating in the trial.
4. Radiologically measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, that includes at least 1 lesion not previously irradiated.
5. Eastern Cooperative Oncology Group (ECOG) 0-1.
6. Have a life expectancy of more than 12 weeks for disease-related mortality, as evaluated by the INV.
7. Patients must be willing to sign an archival tissue release form for research purposes and determination of biomarker (eg NaPi2b) expression.
8. Patients must be willing to undergo a non-contrast high resolution computed tomography (HRCT) of the thorax scan and pulmonary function testing (PFT) at screening.
9. Adequate organ function
10. Resolution of all acute toxic effects of prior therapy or surgical procedures to ≤grade 1 (except alopecia, hyperpigmentation, or discoloration (incl. vitiligo) of the skin and nails, stable immune-related toxicity such as hypothyroidism on hormone replacement, adrenal insufficiency on ≤10 mg daily prednisone \[or equivalent\], chronic grade 2 peripheral sensory neuropathy after prior taxane therapy).
11. Patients of childbearing potential (FCBP) who are sexually active with a non-sterilized partner must use at least one highly effective method of contraception from the time of screening and must agree to continue using such precautions until the end of exposure, plus 5 half-lives and 6 months add-on in the case of patients assigned female at birth. Abstinence is acceptable only as true abstinence when this is in line with the preferred and usual lifestyle of the patient for the duration of the study treatment and the above-referred period after the end of the exposure. Periodic abstinence (e.g., calendar ovulation, symptothermal, post-ovulation methods), the rhythm method, and the withdrawal method are not acceptable methods of contraception.
12. In the opinion of the investigator, the patient must be able to understand, give written informed consent, and comply with all study-related procedures, medication use, and evaluations.
13. The patient must not have a history of non-compliance with medical regimens or be considered potentially unreliable and/or uncooperative.
14. The patient must be willing to sign and date the informed consent form (ICF)
Exclusion Criteria
2. History of hypersensitivity to exatecan or excipients of the TUB-040 formulation, including ADCs with deruxtecan, exatecan or camptothecan as a payload.
3. Disease that is refractory to topoisomerase-I inhibitors, defined as progression during or within 6 months of the last infusion.
4. Patients are not allowed to participate in interventional clinical studies either concurrently or within the previous 28 days or within 5 half-lives of any investigational pharmacologic agents or imaging materials, including dyes, investigational surgical techniques, or devices.
5. Patients with spinal cord compression or active central nervous system disease.
6. Prior radiotherapy \<2 weeks from trial inclusion.
7. Major surgery within 21 days prior to signing the ICF, unless the patient is recovered at that time.
8. Has a history of non-infectious ILD/pneumonitis/radiation pneumonitis that required steroids or has current ILD/pneumonitis.
9. Has an oxygen saturation of \<93% on room air at rest.
10. Has a forced vital capacity of \<60% and diffusing capacity of the lung for carbon monoxide \<70%.
11. Has a QTcF \>470 ms
12. History of nephrotic syndrome
13. Active corneal disease, or history of corneal disease within 12 months prior to enrollment.
14. Active, uncontrolled impairment of the urogenital, renal, hepatobiliary, cardiovascular, gastrointestinal, neurologic, or hematopoietic systems which, in the opinion of the investigator, would predispose the patient to the development of complications from the administration of protocol therapy.
15. History of another malignancy with ongoing treatment or not yet free from disease for 2 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or other malignancy with a similar expected curative outcome.
16. Documented other concurrent non-malignant comorbidities such as unstable or uncontrolled pectoral angina, myocardial infarction during the last 6 months, valvular heart disease that requires treatment, acute myocarditis, or congestive heart failure (CHF) (New York Heart Association III or IV).
17. Any concurrent chemotherapy, radiotherapy (except for local radiation therapy of lesions that may cause imminent complications), immunotherapy, or corticoid therapy.
18. Live vaccines within 30 days prior to study entry.
19. Patients with acute or chronic infections such as:
1. Patients who are HBsAg positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks and have an undetectable HBV viral load prior to randomization.
2. Patients with a history of HCV infection are eligible if HCV viral load is undetectable at screening.
3. HIV infected patients must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease
4. Any other known unresolved and active bacterial, viral, fungal, mycobacterial, or other infection at screening.
5. History of severe and recurrent infections per INV judgment.
6. History of progressive multifocal leukoencephalopathy
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tubulis GmbH
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Guenter Fingerle-Rowson, MD, PhD
Role: STUDY_DIRECTOR
Tubulis GmbH
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mount Sinai
New York, New York, United States
Christ Hospital
Cincinnati, Ohio, United States
Ohio State University
Columbus, Ohio, United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Next Oncology Dallas
Irving, Texas, United States
Next Oncology Virginia
Fairfax, Virginia, 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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Mount Sinai Research Center
Role: primary
Christ Hospital Research Center
Role: primary
Ohio State University Research Center
Role: primary
OU Health Stephenson Cancer Research Center
Role: primary
Role: primary
Next Hospital Research Center
Role: primary
Leuven Clinical Research Center
Role: primary
Charité Universitätsmedizin Berlin Research Center
Role: primary
Cologne Hospital Research Center
Role: primary
Arensia Research Center
Role: primary
Clínica universidad de Navarra Research Center
Role: primary
NEXT Oncology Madrid Research Center
Role: primary
Arensia Research Center
Role: primary
Guy's Hospital Research Center
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-511074-80
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NAPISTAR 1-01
Identifier Type: -
Identifier Source: org_study_id