Testing the Safety and Effects of TUB-030 in Patients with Advanced Head and Neck Cancer or Non-Small-Cell Lung Cancer

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What is this study about?

This study is looking at patients with advanced solid tumors, which are cancers that have spread or cannot be removed by surgery. The study focuses on several specific types of cancer including head and neck squamous cell carcinomas, non-small-cell lung cancer, triple-negative breast cancer, and colorectal cancer. The treatment being tested is called TUB-030, which is a new cancer medicine given through a vein as an intravenous infusion. This medicine is an antibody-drug conjugate, which means it combines a targeted antibody with a cancer-fighting drug to deliver treatment directly to cancer cells.

The purpose of this study is to find out if TUB-030 is safe and well-tolerated by patients, to determine the right dose to use in future studies, and to see if the medicine has any effect on the cancer. The study will also look at how the body processes the medicine by measuring drug levels in the blood at different times. The study has different phases, starting with dose escalation where small groups of patients receive increasing doses to find the maximum safe dose, followed by a dose optimization phase where the most promising dose is tested in larger groups of patients with specific cancer types.

During the study, patients will receive TUB-030 in treatment cycles that last three weeks. The study team will regularly check for side effects, monitor how the cancer responds to treatment using imaging scans, and collect blood samples to measure drug levels and check for immune responses to the medicine. Patients will need to have tissue samples from their tumor available for testing to help understand how the treatment works. The study will continue until the cancer gets worse, side effects become too severe, or the patient and doctor decide to stop treatment.

1 Treatment with TUB-030

Treatment will be administered with TUB-030, which is an investigational cancer medication given through intravenous infusion (directly into a vein).

The medication will be given in treatment cycles, with each cycle lasting 3 weeks.

The specific dose will be determined based on the phase of the study in which participation occurs. During the dose escalation phase, different dose levels are being tested to find the most appropriate dose.

Treatment will continue as long as the disease does not progress and the medication is tolerated without unacceptable side effects.

2 Regular monitoring visits

Throughout the study, regular visits to the study site will be required for monitoring and assessments.

During these visits, physical examinations will be performed and questions about any symptoms or side effects will be asked.

Blood samples will be collected regularly to monitor blood cell counts, liver function (tests measuring how well the liver is working), kidney function (tests measuring how well the kidneys are working), and other laboratory values.

The frequency of these visits will be highest during the first treatment cycle and may decrease in subsequent cycles if the treatment is well tolerated.

3 Imaging scans to assess disease status

Regular imaging scans will be performed to evaluate how the tumor is responding to treatment.

These scans will be done according to RECIST v1.1 criteria, which is a standardized method for measuring tumor size and determining whether the disease is responding, staying stable, or progressing.

The first scan should be performed within 4 weeks before starting treatment.

Subsequent scans will be performed at regular intervals during treatment to track changes in the tumor.

4 Pharmacokinetic assessments

Pharmacokinetic assessments involve taking blood samples at specific times to measure the levels of the study medication in the bloodstream.

These samples help determine how the body processes the medication, including how quickly it is absorbed, distributed, and eliminated.

Blood samples will be collected at designated time points during treatment cycles, particularly during the early cycles.

5 Safety monitoring during the first cycle

The first treatment cycle of 3 weeks is particularly important for safety monitoring.

During this period, close attention will be paid to any side effects or adverse reactions to identify dose-limiting toxicities (serious side effects that may require dose adjustment or discontinuation).

If significant side effects occur during this period, the dose may need to be adjusted or treatment may need to be paused or stopped.

6 Antibody testing

Blood samples will be collected to test for anti-drug antibodies, which are proteins the immune system might produce in response to the study medication.

These tests help determine whether the body is developing an immune response to the medication, which could affect how well it works or cause side effects.

This testing will be performed at specific time points throughout the study.

7 Ongoing treatment and follow-up

Treatment with TUB-030 will continue in 3-week cycles for as long as the disease remains controlled and side effects remain manageable.

The study team will continuously evaluate the response to treatment and overall health status.

If the disease progresses or unacceptable side effects occur, treatment will be discontinued and transition to follow-up will occur.

8 End of treatment and follow-up period

When treatment with TUB-030 ends, a follow-up period will begin.

During this period, continued monitoring for any delayed side effects and disease status will occur.

Follow-up visits and assessments will be scheduled according to the study protocol to ensure ongoing safety monitoring.

Who Can Join the Study?

General Requirements:

You must be 18 years of age or older at the time you sign the consent form
You must be male, or female who is not pregnant and not breastfeeding
Your performance status score must be 0 or 1 on the ECOG scale, which measures how the disease affects your daily living abilities, where 0 means you are fully active and 1 means you have some restrictions but can do light work
Your doctor must expect that you will live more than 12 weeks based on your disease
You must be able and willing to understand and sign the consent form, and follow all study requirements
You must have stored tumor tissue samples available from a previous biopsy, or be willing to provide new tissue samples for testing of specific markers in your tumor

Blood Test Requirements:

Your platelet count must be at least 100,000 per cubic millimeter without recent transfusions or medications to boost platelets in the past 2 weeks
Your hemoglobin level must be at least 8.0 grams per deciliter without recent transfusions or medications to boost red blood cells in the past 2 weeks
Your absolute neutrophil count, which measures infection-fighting white blood cells, must be at least 1,500 per microliter without recent medications to boost white blood cells in the past 2 weeks
Your blood clotting tests must be normal or only slightly elevated, unless you are taking blood thinning medication for a medical reason

Liver and Kidney Function Requirements:

Your total bilirubin level, which measures liver function, must be no more than 1.5 times the upper normal limit, or less than 3 times if you have Gilbert’s Syndrome
Your liver enzyme levels called AST and ALT must be no more than 2.5 times the upper normal limit, or less than 5 times if cancer has spread to your liver
Your kidney filtration rate must be at least 60 milliliters per minute, which shows your kidneys are working adequately

Contraception Requirements for Women:

If you are a woman who can become pregnant and are sexually active with a partner who has not been sterilized, you must use at least one highly effective birth control method starting from screening and continuing until 5 half-lives plus 6 months after your last dose of study drug
Complete abstinence from sexual activity is acceptable only if this is your usual lifestyle throughout the study and the required time after

Contraception Requirements for Men:

If you are a male patient who is sexually active with a woman who can become pregnant, you must use an effective barrier method of birth control without interruption until 5 half-lives plus 6 months after your last dose of study drug
Your female partner who can become pregnant should also use one highly effective barrier method of birth control at the same time
You must not donate sperm during the study and for 6 months after your last dose of study drug

Viral Infection Requirements:

If you test positive for hepatitis B surface antigen, you are eligible if you have been taking antiviral medication for at least 4 weeks and the virus is undetectable in your blood
If you have a history of hepatitis C infection, you are eligible if the virus is undetectable in your blood at screening
If you are infected with HIV, you must be on antiretroviral therapy with a CD4 count above 350 cells per cubic millimeter, have an undetectable viral load for at least 12 weeks, and have been on a stable medication regimen for at least 4 weeks

Cancer Type and Treatment History – Dose Escalation Phase:

You must have advanced or metastatic cancer that has not responded to standard treatment, or you cannot tolerate standard treatment, or your doctor believes no standard treatment is appropriate for you
Your cancer diagnosis must be confirmed by tissue examination and be a type likely to express a specific marker, including head and neck squamous cell carcinoma or non-small-cell lung cancer

Head and Neck Cancer Specific Requirements:

You must have head and neck cancer that cannot be removed by surgery, has come back locally, or has spread to other parts of the body
Your cancer must have started in specific areas of the mouth and throat, and your HPV and other marker status must be known and documented
Your cancer must have gotten worse on at least one prior standard treatment, or you cannot tolerate standard treatment, and your doctor believes no standard treatment is appropriate
You must have received no more than a specific maximum number of prior treatment lines for advanced or metastatic disease

Lung Cancer Specific Requirements:

You must have non-small-cell lung cancer confirmed by tissue examination of specific types including adenocarcinoma, squamous cell carcinoma, large cell carcinoma, or poorly differentiated cancer
If your cancer does not have actionable gene alterations, which are genetic changes that can be treated with approved targeted drugs, you must have received at least one line of platinum-based chemotherapy and immunotherapy, with no more than a specific maximum number of prior treatment lines
If your cancer has actionable gene alterations, you must have received at least one line of targeted therapy and at least one line of platinum-based chemotherapy, with no more than a specific maximum number of prior treatment lines
If your cancer came back after curative chemotherapy-based treatment and your doctor determines you are not a good candidate for repeated chemotherapy, you may be eligible

Prior Treatment Requirements:

If you received previous anti-cancer treatment including chemotherapy or investigational drugs, your last dose must have been at least 4 weeks before starting the study drug, or 6 weeks for certain medications, or 5 half-lives, whichever is shorter
Any side effects from prior treatment, radiation, or surgery must have improved to grade 1 or less, with exceptions for skin color changes, stable thyroid problems controlled with hormone replacement, stable immune-related side effects requiring low-dose steroids, or nerve problems of grade 2 or less

Brain Metastases and Radiation Requirements:

If you have cancer that has spread to your brain, your disease must be stable after radiation therapy before you can enroll
If you received targeted radiation to the brain, at least 7 days must have passed since your last dose, or at least 14 days if you received whole brain radiation
If you received radiation to areas outside the brain affecting a large portion of your bone marrow, at least 28 days must have passed since your last dose
If you received palliative radiation affecting a smaller portion of your bone marrow, at least 14 days must have passed since your last dose

Measurable Disease Requirement:

You must have disease that can be measured on imaging scans according to RECIST version 1.1 criteria, which are standard rules for measuring tumors, confirmed less than 4 weeks before starting treatment
A tumor in a previously radiated area is allowed if it has grown after radiation according to these measurement criteria

Who Cannot Join the Study?

The study information does not list specific reasons why patients cannot participate in this clinical trial
If you are interested in this study, the research team will review your complete medical history to determine if you are eligible to participate
General factors that often prevent participation in cancer studies may include having certain other medical conditions, taking specific medications, or having recent treatments, but these specific exclusion reasons are not provided in the available study information

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital Clinic De Barcelona	Barcelona	Spain
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti	Bucharest	Romania
Itysmbxj Cwexu	Paris	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	01.11.2025
Romania	Recruiting	01.11.2025
Spain	Not yet recruiting	01.11.2025

Trial locations

Investigated drugs:

TUB-030

TUB-030 is an experimental cancer treatment that is being tested for the first time in humans. It is an antibody-drug conjugate, which means it combines a targeted antibody with a chemotherapy drug. The antibody part is designed to find and attach to a specific protein called 5T4 that is found on cancer cells. Once attached, it delivers the chemotherapy drug directly to the cancer cells. This medication is being studied in patients with advanced solid tumors to see if it is safe, how well it is tolerated by the body, and whether it can help fight cancer.

Investigated diseases:

Head and Neck Squamous Cell Carcinoma – This is a type of cancer that develops in the moist tissues lining the mouth, nose, and throat. The disease begins when flat, thin cells called squamous cells start growing abnormally and form tumors. These cancerous growths can occur in various locations including the lips, inside of the mouth, throat, voice box, and nasal passages. As the disease advances, the tumor grows larger and may spread to nearby lymph nodes in the neck. In metastatic cases, cancer cells break away from the original tumor and travel through the bloodstream or lymphatic system to form new tumors in distant parts of the body. The progression from localized to advanced or metastatic stages represents a more widespread form of the disease.

Non-Small Cell Lung Cancer – This is the most common type of lung cancer, accounting for the majority of all lung cancer cases. The disease starts when cells in the lung begin to grow out of control and form a mass or tumor. Unlike small cell lung cancer, this type grows and spreads more slowly in its early stages. As the cancer progresses, it can invade nearby tissues and spread to lymph nodes in the chest. In advanced stages, the cancer may metastasize, meaning it spreads to other parts of the body such as the bones, liver, brain, or other lung. The disease can continue to grow and affect multiple organs if it reaches the metastatic stage.

Trial ID:

2025-522517-35-00

Protocol code:

5-STAR 1-01

NCT ID:

NCT06657222

Trial Phase:

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

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Testing the Safety and Effects of TUB-030 in Patients with Advanced Head and Neck Cancer or Non-Small-Cell Lung Cancer

What is this study about?

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