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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

13 criteria

  • 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 trial?

7 criteria

  • 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.
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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.

What is already known about the treatment

SKB264 – This medication is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials for its effectiveness in treating metastatic or locally advanced solid tumors that cannot be surgically removed and have not responded to standard treatments. The main therapeutic indication is for patients with these specific types of tumors. SKB264 works at the molecular level by targeting and inhibiting specific pathways that cancer cells use to grow and spread. It is classified pharmacologically as an investigational drug, as it is still under study to determine its safety and efficacy.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508700-38-00Protocol codeKL264-01Estimated enrolment1 261 patientsSponsorSichuan Kelun-Biotech Biopharmaceutical Co. Ltd.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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