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Study of JK08, Pembrolizumab, and Lenvatinib for Patients with Advanced or Metastatic Cancer

Fast replyRegistered drugNo placebo
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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 for patients with unresectable locally advanced or metastatic cancer. The treatment being tested is called JK08, which is an IL-15 antibody fusion protein that targets CTLA-4. This study will explore the use of JK08 both on its own and in combination with other treatments. The trial will also involve the use of Keytruda (known as pembrolizumab) and Lenvima (known as lenvatinib) in certain combinations. Keytruda is a medication used for various types of cancer, and Lenvima is a type of medication known as a receptor tyrosine kinase inhibitor, which helps to block certain proteins that promote cancer cell growth.

The purpose of this study is to understand the safety and tolerability of JK08, as well as to determine the best dose for patients. The study will begin with a phase where different doses of JK08 are tested to find the maximum dose that patients can tolerate. After this, the study will expand to include more patients to further evaluate the optimal dose. Patients participating in the study will receive JK08 through subcutaneous use, which means it is injected under the skin. Some patients may also receive Keytruda through infusion, which is a method of delivering medication directly into the bloodstream, or Lenvima in the form of hard capsules taken orally.

This trial is open to patients with various types of advanced cancers, including non-small cell lung cancer, small cell lung cancer, melanoma, renal cell carcinoma, urothelial cancer, head and neck squamous cell cancer, breast cancer, gastric cancer, esophageal cancer, pancreatic cancer, liver cancer, colorectal cancer, ovarian cancer, cervical cancer, endometrial cancer, and thyroid cancer. The study aims to provide new insights into the treatment of these cancers and potentially offer new therapeutic options for patients who have limited treatment choices.

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

    Joining the study

    Upon joining the study, the patient will undergo an initial assessment to confirm eligibility. This includes a review of medical history, current health status, and any previous treatments for cancer.

    The patient must provide informed consent, agreeing to participate in the study and comply with its procedures.

  2. Step 2

    Treatment phase 1: jk08 administration

    The patient will receive JK08, an experimental drug, administered subcutaneously (under the skin) once a week. The purpose is to determine the safest and most effective dose.

    Regular monitoring will occur to assess the patient's response to the treatment and any side effects.

  3. Step 3

    Treatment phase 2: combination therapy

    Depending on the specific cancer type, the patient may receive additional medications in combination with JK08.

    For some patients, Pembrolizumab (KEYTRUDA) will be administered as a solution for infusion. The dosage and frequency will be determined based on the patient's response and tolerance.

    Other patients may receive Lenvatinib (LENVIMA) in the form of oral capsules. The dosage will be adjusted according to the patient's needs and treatment plan.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, the patient will have regular clinic visits for monitoring. This includes blood tests, imaging studies, and assessments of overall health and treatment response.

    The patient will be observed for any side effects or adverse reactions to the medications.

  5. Step 5

    End of study

    The study is expected to conclude by February 2026. At the end of the study, the patient's overall response to the treatment will be evaluated.

    The patient will receive guidance on any further treatment options or follow-up care needed after the study.

Who can join the trial?

15 criteria

  • Must be at least 18 years old.
  • Must agree to have a fresh tumor biopsy before and during treatment, except for certain groups where it's not required.
  • Women who can have children must have a negative pregnancy test before starting the study and use two forms of effective birth control during the study and for 90 days after the last dose. Abstinence is also an option if it's the chosen method.
  • Men with partners who can have children must use effective barrier birth control during the study and for 90 days after stopping the study drug. They can also choose abstinence if it's their preferred method.
  • If cancer has spread to the brain, it must have been treated and not causing symptoms for at least 14 days. No ongoing treatment for brain disease is allowed.
  • Must be willing and able to attend clinic visits and follow study procedures.
  • Can use hormones for breast cancer or other conditions like diabetes. Certain medications for bone health are also allowed.
  • Must sign a consent form and be willing to follow study procedures and visit schedules.
  • For the initial phase, must have a specific type of cancer that cannot be removed by surgery or has spread, and have tried standard treatments without success or cannot have them for medical reasons.
  • For the expansion phase, must have specific types of cancer and meet certain conditions related to previous treatments.
  • Must have a performance status of 0 or 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
  • Must have a life expectancy of at least 12 weeks.
  • Must have measurable disease as determined by specific imaging tests like CT or MRI.
  • Must have acceptable lab test results, including certain levels of albumin, platelets, hemoglobin, and other blood components.
  • Must provide a sample of a previous tumor, either as a tissue block or a series of slides.
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Investigated drugs

JK08 is an experimental medication being studied for its potential to treat advanced or metastatic cancer. It is a fusion protein that combines an antibody with IL-15, a molecule that can help stimulate the immune system. This medication is designed to target CTLA-4, a protein that can suppress the immune response against cancer cells. The study aims to determine the safety and effectiveness of JK08 when given alone or in combination with other treatments.

What is already known about the treatment

JK08 – JK08 is administered as a subcutaneous injection, typically on a weekly schedule. It is currently being studied in clinical trials, specifically in a Phase 1/2 study, to assess its safety and effectiveness in treating patients with unresectable locally advanced or metastatic cancer. The main therapeutic indication for JK08 is its potential use in cancer treatment, particularly for cases that cannot be surgically removed. At the molecular level, JK08 is an IL-15 antibody fusion protein that targets CTLA-4, a protein involved in regulating the immune system, potentially enhancing the body's ability to fight cancer cells. It falls under the pharmacological classification of immunotherapy agents, which are designed to boost the immune response against cancer.

Investigated diseases

Unresectable Locally Advanced or Metastatic Cancer – This type of cancer refers to tumors that cannot be surgically removed due to their location or extent of spread. "Locally advanced" means the cancer has grown beyond the original site but has not yet spread to distant parts of the body. "Metastatic" indicates that the cancer has spread to other organs or tissues. These cancers can affect various parts of the body and may cause symptoms depending on their location and size. The progression of the disease can vary widely, with some tumors growing slowly and others spreading rapidly. The focus is often on managing symptoms and slowing the progression of the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-511750-53-00Protocol codeJK08.1.01Estimated enrolment263 patientsSponsorSalubris Biotherapeutics Inc.

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