Study on the Safety and Tolerability of TUB-040 for Patients with Platinum-Resistant Ovarian Cancer or Relapsed/Refractory Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying two types of cancer: platinum-resistant high-grade ovarian cancer and relapsed/refractory adenocarcinoma non-small cell lung cancer. The treatment being tested is a new medication called TUB-040, which is delivered through an intravenous infusion. The purpose of the study is to investigate the safety and tolerability of this new treatment in patients whose cancer has not responded to standard therapies.

The study will be conducted in two phases. In the first phase, different doses of TUB-040 will be tested to determine the safest and most effective dose. This phase will help identify any side effects and how the body processes the medication. In the second phase, the focus will be on optimizing the dose and further assessing the safety and preliminary effectiveness of TUB-040 in treating the cancers.

Participants in the study will receive the medication through an intravenous infusion, and their health will be closely monitored throughout the trial. The study aims to gather important information that could lead to new treatment options for patients with these challenging types of cancer. Some participants may receive a placebo as part of the study design. The trial is expected to continue until early 2027, with recruitment starting in mid-2024.

1 Joining the study

Upon joining the study, the patient will be required to provide written informed consent. This involves understanding and agreeing to comply with all study-related procedures, medication use, and evaluations.

The patient must meet specific criteria, such as having a confirmed diagnosis of either platinum-resistant high-grade ovarian cancer or relapsed/refractory adenocarcinoma non-small cell lung cancer.

2 Screening and baseline assessments

The patient will undergo various assessments to confirm eligibility, including a review of medical history, physical examination, and laboratory tests to ensure adequate organ function.

A non-contrast high-resolution CT scan of the thorax and pulmonary function testing will be conducted.

3 Phase I: Dose escalation

The patient will receive the investigational drug TUB-040 through an intravenous infusion. The purpose is to determine the safety and tolerability of the drug and to identify the maximum tolerated dose.

The frequency and duration of administration will be determined based on the patient’s response and any side effects experienced.

4 Phase IIa: Dose optimization

In this phase, the patient will continue to receive TUB-040 at the identified dose for optimization. The focus will be on assessing the safety and preliminary effectiveness of the drug.

The patient’s response to the treatment will be monitored, and adjustments to the dosage may be made as necessary.

5 Monitoring and follow-up

Throughout the trial, the patient will be closely monitored for any adverse effects or changes in their condition. Regular assessments will be conducted to evaluate the patient’s response to the treatment.

The patient will be required to attend follow-up visits as scheduled to ensure ongoing safety and to collect data on the drug’s effectiveness.

Who Can Join the Study?

Patients with ovarian cancer: Must have a confirmed diagnosis of high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
All patients: Must be able to understand, give written consent, and follow all study procedures and evaluations.
All patients: Must not have a history of not following medical instructions or be considered unreliable or uncooperative.
Patients with ovarian cancer: Must have platinum-resistant disease, meaning the cancer did not respond to platinum-based treatments as expected.
All patients: Must be willing to sign and date the informed consent form.
Patients with ovarian cancer: Must have received no more than 5 lines of platinum-based therapy and 2 lines of non-platinum-based therapy.
Patients with lung cancer: Must have a confirmed diagnosis of non-small cell lung cancer of the adenocarcinoma subtype.
Patients with lung cancer: Must have had the cancer progress after previous treatments, including platinum-based therapy or a checkpoint inhibitor if needed.
Patients with lung cancer: Must not be eligible for other standard treatments for specific genetic mutations or alterations.
All patients: Must be male or a non-pregnant, non-breastfeeding female aged 18 years or older.
All patients: Must have a disease that cannot be cured with current treatments.
All patients: Must have a measurable disease according to specific medical criteria.
All patients: Must have tried all standard treatments with expected benefits and not be denied these treatments by joining the trial.
All patients: Previous treatment with certain cancer drugs is allowed.
All patients: Must have stable brain metastases after treatment with no progression in MRI scans.
All patients: Must have a good performance status, meaning they can carry out daily activities with little or no assistance.
All patients: Must have a life expectancy of more than 12 weeks.
All patients: Must be willing to provide a tissue sample for research purposes.
All patients: Must be willing to undergo specific scans and lung function tests during screening.
All patients: Must have adequate organ function based on specific medical tests.
All patients: Must have resolved any side effects from previous treatments to a mild level, except for certain conditions like hair loss or skin changes.
All patients: Those who can have children must use effective birth control methods during the study and for a period after the study ends.

Who Cannot Join the Study?

Patients with other types of cancer that are not specified in the study.
Patients who are currently receiving treatment that might interfere with the study medication.
Patients with severe health conditions that could make participation unsafe.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients with known allergies to the study medication or its ingredients.
Patients who are unable to follow the study procedures or attend required visits.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Udjiixbbbk Htulamer Csnmbos	Cologne	Germany
Hbxiycny Vlqm dfrmerwk	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	15.08.2024
Germany	Recruiting	15.08.2024
Romania	Recruiting	15.08.2024
Spain	Recruiting	15.08.2024

Trial locations

Investigated drugs:

Tub-040

TUB-040 is an experimental medication being studied for its potential to treat certain types of cancer. It is an antibody-drug conjugate, which means it combines an antibody with a drug to specifically target and attack cancer cells. This medication is being tested in patients with platinum-resistant high-grade ovarian cancer and relapsed or refractory adenocarcinoma non-small cell lung cancer. The study aims to determine how safe and tolerable TUB-040 is for patients, as well as to find the most effective dose for future treatments.

Investigated diseases:

Platinum-resistant high-grade ovarian cancer – This type of ovarian cancer does not respond to platinum-based chemotherapy, which is a common treatment for ovarian cancer. It is characterized by the recurrence or progression of the disease within six months after completing platinum-based therapy. The cancer cells are high-grade, meaning they are more aggressive and tend to grow and spread more quickly. This condition often presents with symptoms such as abdominal pain, bloating, and changes in bowel habits. The progression of the disease can lead to the spread of cancer to other parts of the body. Management focuses on controlling symptoms and slowing the progression of the disease.

Relapsed/refractory adenocarcinoma non-small cell lung cancer – This form of lung cancer is characterized by the recurrence or persistence of the disease despite initial treatment. Adenocarcinoma is a type of non-small cell lung cancer that originates in the glandular cells of the lung. It is the most common type of lung cancer in non-smokers and tends to grow more slowly than other types. Symptoms may include a persistent cough, chest pain, and shortness of breath. The disease can progress by spreading to other parts of the body, such as the bones or brain. The focus is on managing symptoms and attempting to control the spread of the cancer.

Trial ID:

2024-511074-80-01

Protocol code:

NAPISTAR 1-01

NCT ID:

NCT06303505

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study on the Safety and Tolerability of TUB-040 for Patients with Platinum-Resistant Ovarian Cancer or Relapsed/Refractory Non-Small Cell Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?