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

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.

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.

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.

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.

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.

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.

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.