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Tests treatment safety and results for Ovarian Cancer
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
ClinicalTrials.gov ID: NCT06303505
What this study is testing
What is TUB-040?
TUB-040 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- (for all patients)
- Male or non-pregnant, non-breastfeeding female, age 18 years or older at the date of consent.
- Disease not amenable to curative intent treatment.
- Patients have exhausted the standard of care treatment (SoC) with expected survival benefit and are not denied SoC with expected survival benefit by...
- Radiologically measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, that includes at least 1 lesion not previously...
You likely can't join if
- (for all patients)
- The patient is pregnant, lactating or breastfeeding or has a positive serum pregnancy test during the screening period.
- History of hypersensitivity to exatecan or excipients of the TUB-040 formulation, including ADCs with deruxtecan, exatecan or camptothecan as a...
- Disease that is refractory to topoisomerase-I inhibitors, defined as progression during or within 6 months of the last infusion.
- Patients are not allowed to participate in treatment clinical studies either concurrently or within the previous 28 days or within 5 half-lives of...
- Patients with spinal cord compression or active central nervous system disease.
See the full eligibility criteria
- (for all patients)
- Male or non-pregnant, non-breastfeeding female, age 18 years or older at the date of consent.
- Disease not amenable to curative intent treatment.
- 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.
- Radiologically measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, that includes at least 1 lesion not previously irradiated.
- Eastern Cooperative Oncology Group (ECOG) 0-1.
- Have a life expectancy of more than 12 weeks for disease-related mortality, as evaluated by the INV.
- Patients must be willing to sign an archival tissue release form for research purposes and determination of biomarker (eg NaPi2b) expression.
- 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.
- Adequate organ function
- 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...
- 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...
- 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.
- The patient must not have a history of non-compliance with medical regimens or be considered potentially unreliable and/or uncooperative.
- The patient must be willing to sign and date the informed consent form (ICF)
- (for all patients)
- The patient is pregnant, lactating or breastfeeding or has a positive serum pregnancy test during the screening period.
- History of hypersensitivity to exatecan or excipients of the TUB-040 formulation, including ADCs with deruxtecan, exatecan or camptothecan as a payload.
- Disease that is refractory to topoisomerase-I inhibitors, defined as progression during or within 6 months of the last infusion.
- Patients are not allowed to participate in treatment clinical studies either concurrently or within the previous 28 days or within 5 half-lives of any investigational pharmacologic agents or imaging materials, including...
- Patients with spinal cord compression or active central nervous system disease.
- Prior radiotherapy \<2 weeks from trial inclusion.
- Major surgery within 21 days prior to signing the ICF, unless the patient is recovered at that time.
- Has a history of non-infectious ILD/pneumonitis/radiation pneumonitis that required steroids or has current ILD/pneumonitis.
- Has an oxygen saturation of \<93% on room air at rest.
- Has a forced vital capacity of \<60% and diffusing capacity of the lung for carbon monoxide \<70%.
- Has a QTcF \>470 ms
- History of nephrotic syndrome
- Active corneal disease, or history of corneal disease within 12 months prior to enrollment.
- 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...
- 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...
- 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...
- Any concurrent chemotherapy, radiotherapy (except for local radiation therapy of lesions that may cause imminent complications), immunotherapy, or corticoid therapy.
- Live vaccines within 30 days prior to study entry.
- Patients with acute or chronic infections such as:
- 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.
- Patients with a history of HCV infection are eligible if HCV viral load is undetectable at screening.
- HIV infected patients must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease
- Any other known unresolved and active bacterial, viral, fungal, mycobacterial, or other infection at screening.
- History of severe and recurrent infections per INV judgment.
- History of progressive multifocal leukoencephalopathy
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Irving, Texas, United States
- Fairfax, Virginia, United States
- Leuven, Belgium, Belgium
- Berlin, Germany
- Cologne, Germany
- Cluj-Napoca, Romania
- Madrid, Spain
- Kyiv, Ukraine
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; New York, New York, United States; Cincinnati, Ohio, United States; Columbus, Ohio, United States; Oklahoma City, Oklahoma, United States; Irving, Texas, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.