A Study Testing TUB-040 Combined with Standard Cancer Drugs for Patients with High-Grade Epithelial Serous or Endometrioid Ovarian Cancer

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What is this study about?

This study involves patients with high-grade epithelial serous or endometrioid epithelial ovarian cancer, which are types of cancer that begin in the ovaries, fallopian tubes, or the lining of the abdomen. The study will test a new medication called TUB-040, which is given through a vein as an intravenous infusion. This medication will be used together with standard drugs that are commonly used to treat ovarian cancer. The purpose of this study is to find out if TUB-040 is safe and well-tolerated when combined with standard ovarian cancer treatments, and to determine the highest dose that can be given without causing serious side effects. The study will also look at how well this combination works in treating the cancer.

During the study, patients will receive TUB-040 along with standard chemotherapy drugs. The medication is designed to target specific features of cancer cells. Doctors will monitor patients closely to check for any unwanted effects or side effects that may occur during treatment. Blood tests and other medical evaluations will be done regularly to check how the body is responding to the treatment and to measure the levels of the medication in the blood. Scans will be performed to see if the tumors are getting smaller or if the cancer is staying stable. The study will also collect tumor tissue samples to examine certain markers in the cancer cells that might help predict how well the treatment will work.

The study will measure several outcomes including the number and severity of side effects that patients experience, how the medication moves through the body, and whether the body develops an immune response to the medication. Doctors will also assess how many patients respond to the treatment, how long it takes for the cancer to respond, how long the response lasts, and how long patients live without their cancer getting worse. Additional measurements will include changes in a blood marker called CA-125, which is often used to monitor ovarian cancer. Patients who join this study will have already received previous treatments for their ovarian cancer and their cancer will have come back or progressed after earlier therapy.

1 Screening and eligibility confirmation

Blood samples will be collected to check blood cell counts, liver function, kidney function, and other laboratory values. The kidney function will be measured using a calculation called glomerular filtration rate, which must be at least 60 milliliters per minute.

Tests will be performed to check for hepatitis B and hepatitis C infections. If hepatitis B surface antigen is detected, antiviral treatment must have been received for at least 4 weeks with undetectable viral load. If there is a history of hepatitis C infection, the viral load must be undetectable.

Imaging scans will be performed to confirm that the cancer can be measured according to standard criteria called RECIST version 1.1. At least one tumor must be measurable.

A tumor tissue sample will be required for laboratory analysis to determine biomarker expression. This can be either a stored tissue block or at least 6 freshly cut tissue sections from a previous biopsy. If no stored tissue is available, a new biopsy may need to be performed.

Physical examination and performance status assessment will be conducted. Performance status is rated on a scale from 0 to 1, where 0 means fully active and 1 means restricted in physically strenuous activity but able to carry out light work.

Any side effects from previous cancer treatments must have resolved to mild severity or less, except for hair loss, skin color changes, stable thyroid problems managed with hormone replacement, or low-dose steroid treatment.

2 Washout period from previous treatments

If previous anti-cancer medication was received, a waiting period of either five half-lives of that medication or 4 weeks, whichever is shorter, must be completed before starting the study treatment.

If radiation therapy was received, at least 2 weeks must have passed since the last radiation treatment.

If major surgery was performed, at least 4 weeks must have passed and recovery from surgery side effects to mild severity or less must have occurred.

3 First treatment cycle and dose-limiting toxicity monitoring

Treatment will begin with TUB-040, which is given as an intravenous infusion, meaning it is administered directly into a vein over a period of time.

TUB-040 will be given in combination with standard ovarian cancer medications. The specific dose of TUB-040 will be determined as part of the study to find the maximum tolerated dose.

During the first treatment cycle, close monitoring will occur to identify any dose-limiting toxicities, which are serious side effects that may require dose adjustment.

Blood samples will be collected at specific times to measure the levels of TUB-040, the antibody component, and the active drug component called exatecan in the bloodstream. This is called pharmacokinetics assessment.

4 Ongoing treatment cycles

Treatment with TUB-040 in combination with standard ovarian cancer drugs will continue in repeated cycles.

Regular blood tests will be performed to monitor blood cell counts, liver function, kidney function, and other laboratory values.

A blood test called CA-125 will be measured regularly to monitor cancer response according to specific criteria.

Physical examinations and assessments of how the body is functioning will be performed at regular intervals.

Blood samples will be collected periodically to test for anti-drug antibodies, which are immune responses the body may develop against TUB-040.

5 Tumor response assessment

Imaging scans will be performed at scheduled intervals to measure the size of tumors and assess whether they are shrinking, staying stable, or growing.

Tumor measurements will be evaluated according to RECIST version 1.1 criteria to determine the response to treatment.

The treating physician will assess the objective response rate, which is the proportion of patients whose tumors shrink by a certain amount.

Other measurements will include time to first response, which is how long it takes for the tumor to start shrinking, duration of response, which is how long the tumor shrinkage lasts, and progression-free survival, which is the length of time without the cancer getting worse.

6 Safety monitoring throughout the study

All side effects will be recorded and evaluated for severity throughout the study period. These are called treatment-emergent adverse events.

Any serious side effects that require hospitalization, are life-threatening, or result in significant disability will be classified as serious adverse events and will be closely monitored.

Laboratory test results showing abnormalities of grade 3 or higher, which indicates severe abnormalities, will be tracked and managed.

Regular assessments will be conducted to ensure safety and tolerability of the treatment combination.

7 End of treatment and follow-up

Treatment will continue until the cancer progresses, unacceptable side effects occur, or another reason for stopping treatment arises.

After the last dose of study medication, follow-up assessments will continue for a specified period.

Contraception must be continued for at least 6 months after the last dose of any study medication, whichever medication requires the longest contraception period.

Final safety assessments and tumor evaluations will be performed according to the study schedule.

Who Can Join the Study?

You must be a female who is 18 years of age or older at the time of your first screening visit
You must have an ECOG performance status of 0 or 1, which is a score that measures how well you can perform your daily activities, with 0 meaning you are fully active and 1 meaning you have some restrictions but can still do light work
You must have been diagnosed with advanced high-grade serous or endometrioid epithelial ovarian cancer, which are specific types of cancer that affect the ovaries, fallopian tubes, or the lining of the abdomen, confirmed by examining tissue under a microscope
Your cancer must have come back after previous treatment and you must have responded to your last treatment, but not progressed within 6 months (182 days) after your last dose of that treatment
You must have at least one tumor that can be measured on imaging scans, which may include a tumor in an area that was previously treated with radiation and has grown
Your cancer must have gotten worse on imaging scans during or after your most recent cancer treatment
You must have had 1 to 2 previous lines of treatment for your cancer and not progressed within 182 days after your last dose of that treatment
If you were previously found to have certain genetic changes in your cancer cells, you must have been treated with a PARP inhibitor, which is a type of cancer drug, if this treatment was available in your area at the time
Your blood cell counts must be adequate: platelet count at least 100,000 per cubic millimeter (without transfusions or growth factors in the past 4 weeks), hemoglobin at least 9.0 grams per deciliter (without transfusions or growth factors in the past 4 weeks), and absolute neutrophil count at least 1,500 per microliter (without growth factors in the past 4 weeks)
Your blood clotting tests must be normal or near normal, unless you are taking blood thinning medications for a medical reason, in which case your levels should be within the appropriate range
Your liver function must be adequate, with bilirubin levels no more than 1.5 times the upper limit of normal, and liver enzyme levels (AST and ALT) no more than 2.5 times the upper limit of normal, unless you have liver metastases, in which case up to 5 times the upper limit is acceptable
Your alkaline phosphatase level, which is an enzyme in your blood, must be less than 2.5 times the upper limit of normal, unless there is another reason for elevation such as cancer spread to the bones
Your kidney function must be adequate, with a glomerular filtration rate of at least 60 milliliters per minute, which measures how well your kidneys filter waste from your blood
You must be willing to provide a sample of your tumor tissue from a previous biopsy or surgery for research and testing purposes, or have a new biopsy performed if no previous sample is available
Any side effects from previous treatments or surgeries must have resolved to mild or no symptoms, except for hair loss, skin color changes, stable thyroid problems being treated with hormone replacement, or if you are taking 10 milligrams or less of prednisone daily
You may have been previously treated with certain types of cancer drugs including topoisomerase 1 inhibitors or antibody-drug conjugates, but not those that target the same protein as the study drug or use similar components
You must have completed a waiting period after your previous cancer treatments: at least 4 weeks or five half-lives (whichever is shorter) for chemotherapy, at least 2 weeks for radiation therapy, and at least 4 weeks for major surgery
If you have hepatitis B, you must have been on antiviral treatment for at least 4 weeks and have undetectable virus levels in your blood
If you have a history of hepatitis C, the virus must be undetectable in your blood at screening
If you are able to become pregnant and sexually active with a partner who has not been sterilized, you must use at least one highly effective birth control method from screening until at least 6 months after your last dose of study treatment
You must agree not to donate eggs and not to breastfeed while on study treatment and for 6 months after your last dose
You must be considered post-menopausal, which means you have had surgery to remove your ovaries or fallopian tubes or uterus, or have not had menstrual periods for 12 months without another medical reason
You must be able to understand the study, willing to sign the informed consent form, and able to follow all study procedures and requirements

Who Cannot Join the Study?

You cannot participate if you are male, as this study only includes female patients
You cannot participate if you are under 18 years old, as this study is only for adults
You cannot participate if you do not have high-grade epithelial serous or endometrioid epithelial ovarian cancer, which are specific types of ovarian cancer that grow in the tissue covering the ovary or in the lining inside the ovary

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Centre hospitalier universitaire de Liege	Liege	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium
Ctxxqeebg Urphblgmlixmkz Skjfcnyrd	Woluwe-Saint-Lambert	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	16.03.2026

Trial locations

Investigated drugs:

Tub-040

TUB-040 is an investigational medication being tested in this clinical trial. It is given in combination with standard ovarian cancer drugs to treat patients with high-grade epithelial serous or endometrioid epithelial ovarian cancer. The study aims to find out if this medication is safe and well-tolerated when used together with other cancer treatments, and to determine the appropriate dose that patients can receive without experiencing serious side effects.

High-grade Epithelial Serous Ovarian Cancer – This is a type of cancer that develops in the ovary from the epithelial cells that cover its surface, specifically the serous subtype. The cancer cells in this form are classified as high-grade, meaning they appear very abnormal under a microscope and tend to grow and spread more rapidly than low-grade forms. This cancer typically begins in the outer layer of the ovary and can spread to other parts of the pelvis and abdomen. As the disease progresses, cancer cells may accumulate fluid in the abdomen and spread to nearby organs. High-grade serous ovarian cancer is the most common subtype of epithelial ovarian cancer. The disease often advances silently in early stages, making it frequently detected at more advanced stages.

High-grade Endometrioid Epithelial Ovarian Cancer – This is a type of ovarian cancer that arises from epithelial cells and resembles the lining of the uterus under microscopic examination. The high-grade classification indicates that the cancer cells are poorly differentiated and have a more aggressive growth pattern. This form of ovarian cancer originates in the ovary but shares cellular characteristics with endometrial tissue. The cancer can grow within the ovary and extend to surrounding pelvic structures as it advances. Endometrioid ovarian cancer represents a smaller proportion of epithelial ovarian cancers compared to the serous type. The progression involves local spread initially, with potential for wider dissemination throughout the abdominal cavity.

Trial ID:

2025-524691-33-00

Protocol code:

NAPISTAR 1-02

Trial Phase:

Human Pharmacology (Phase I) – Other

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A Study Testing TUB-040 Combined with Standard Cancer Drugs for Patients with High-Grade Epithelial Serous or Endometrioid Ovarian Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?