Study of SKB264 for Patients with Advanced Solid Tumors Not Responding to Standard Treatments

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What is this study about?

This clinical trial is focused on studying a new treatment called SKB264 for patients with advanced and hard-to-treat cancers, specifically those with metastatic or locally advanced unresectable solid tumors. These are cancers that have spread to other parts of the body or cannot be removed through surgery and have not responded well to standard treatments. The purpose of the study is to evaluate how well SKB264 works when given as a single treatment through an intravenous infusion, which means it is administered directly into the bloodstream.

During the study, participants will receive SKB264 and will be monitored for their response to the treatment. The study will look at how many patients experience a reduction in their cancer size or complete disappearance of the cancer. The study will also monitor for any side effects or adverse reactions to the treatment. The treatment period is expected to last up to 74 weeks, and participants will have regular check-ups and assessments to track their progress and any changes in their condition.

In addition to SKB264, the study will also involve other medications that may be used to manage symptoms or side effects. These include cimetidine, roxatidine, famotidine, ranitidine hydrochloride, nizatidine, and combinations like famotidine, calcium carbonate, and magnesium hydroxide. The study aims to provide valuable information on the effectiveness and safety of SKB264 for patients with these challenging cancer types.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

Eligibility criteria include having a solid tumor that is not responding to standard treatments and meeting specific health requirements such as adequate kidney function and blood cell counts.

2 treatment administration

The treatment involves the administration of SKB264, a medication given through an intravenous infusion.

The dosage and frequency of administration are determined based on the recommended dose levels (RDEs) established during the study.

3 monitoring and evaluation

Regular monitoring is conducted to evaluate the response to the treatment. This includes imaging tests like CT or MRI to measure tumor size.

The primary goal is to assess the objective response rate, which includes complete or partial reduction in tumor size.

4 safety assessments

Safety assessments are performed to monitor for any adverse effects of the treatment. This includes regular blood tests and health evaluations.

The study tracks both common and serious adverse events to ensure patient safety.

5 study completion

The study is expected to continue until November 2025, with regular follow-ups to assess long-term outcomes and overall survival.

Upon completion, final evaluations are conducted to summarize the treatment’s effectiveness and safety.

Who Can Join the Study?

Patients must be able to provide documented voluntary informed consent, meaning they agree to participate after understanding the study.
Creatinine clearance must be at least 30 mL/min. This is a measure of how well the kidneys are working.
If female patients can have children or male patients have partners who can have children, they must agree to use a highly effective form of birth control during the study.
Patients must have recovered from any side effects from previous treatments, except for hair loss and skin color changes. If they have hormone-related side effects, they can join if they are stable and have no symptoms.
Patients should be expected to live for at least 3 more months.
Patients must have an ECOG Performance Status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
Patients must be 18 years or older.
Patients must have cancer that is confirmed by a lab test and cannot be cured, is locally advanced, has come back, or has spread to other parts of the body.
Patients must have a tumor that can be measured by a CT or MRI scan.
Patients should have a solid tumor that cannot be removed by surgery and does not respond to standard treatments.
Patients must have a certain level of blood cells: neutrophil count of at least 1.5 billion per liter, platelet count of at least 100 billion per liter, and hemoglobin of at least 9 grams per deciliter without recent blood treatments.
Blood clotting tests must be within a certain range: INR and aPTT should be no more than 1.5 times the upper limit of normal.
Liver function tests must be within a certain range: total bilirubin should be no more than 1.5 times the upper limit of normal, except for patients with Gilbert disease, and AST and ALT should be no more than 2.5 times the upper limit of normal, except for patients with liver metastases where it can be up to 5 times the upper limit.

Who Cannot Join the Study?

Patients who have not tried all available standard treatments for their cancer.
Patients with tumors that can be surgically removed.
Patients who are not experiencing tumor growth after standard treatments.
Patients who are not within the specified age range for the study.
Patients who are not able to receive the treatment through an IV (intravenous) method.
Patients who are not part of the specified clinical trial group.
Patients who are not considered part of the vulnerable population selected for the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Universita Degli Studi Di Brescia	Brescia	Italy
Ifadvcnr Ruqtdkveu Pyn Lw Siaeaa Djr Tulvzu Djbk Aprljcj Igbr Sqcdnu	Meldola	Italy
Awgiimd Oltdguwmwrx Ugcpqyfrabpkn Scrmjr	Siena	Italy
Hjtfdvlw Vdhc dmqujyos	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	17.06.2024
Spain	Not recruiting	17.06.2024

Trial locations

Investigated drugs:

SKB264 is an investigational medication being studied for its potential to treat patients with advanced solid tumors that cannot be surgically removed and have not responded to standard treatments. This medication is administered intravenously, meaning it is given directly into a vein. The study aims to assess how well SKB264 can shrink or eliminate these tumors, focusing on its ability to achieve either a complete or partial response in patients.

Investigated diseases:

Neoplasm malignant

Metastatic or Locally Advanced Unresectable Solid Tumors – These are cancers that have spread from their original site to other parts of the body or are too advanced to be removed surgically. They can occur in various organs and tissues, forming solid masses. As the disease progresses, the tumors may grow larger and spread to nearby or distant organs. This progression can lead to a range of symptoms depending on the location and size of the tumors. The condition is typically diagnosed when standard therapies have failed to control the tumor growth. The focus is often on managing symptoms and slowing the progression of the disease.

Trial ID:

2023-508700-38-00

Protocol code:

KL264-01

NCT ID:

NCT04152499

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of SKB264 for Patients with Advanced Solid Tumors Not Responding to Standard Treatments

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?