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Study of JK06 for Patients with Advanced or Metastatic Cancer

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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 JK06, which is a type of medication known as an antibody-drug conjugate (ADC). This medication is given to patients through an infusion into a vein, which means it is delivered directly into the bloodstream. The study aims to understand how safe and tolerable this treatment is for patients, as well as to determine the best dose to use in future studies.

The trial will include patients with various types of advanced cancers, such as non-small cell lung cancer, renal cell carcinoma, urothelial bladder cancer, head and neck squamous cell cancer, breast cancer, gastric or gastroesophageal adenocarcinoma, epithelial ovarian cancer, cervical cancer, endometrial adenocarcinoma, prostate cancer, and soft tissue sarcoma. The study will be conducted in two phases. The first phase will focus on finding the right dose of JK06 by gradually increasing the amount given to patients. The second phase will involve giving the selected dose to more patients to further evaluate its effects.

Throughout the study, patients will receive the treatment every three weeks and will be monitored closely for any side effects or changes in their condition. The goal is to gather information that will help in developing JK06 as a potential treatment option for people with these types of advanced cancers. The study is expected to continue until 2028, with recruitment starting in 2024.

The research process

The trial runs in 4 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 a series of initial assessments to confirm eligibility. This includes a review of medical history, physical examination, and necessary laboratory tests.

    A fresh tumor biopsy may be required for certain patients, depending on the phase of the study they are entering.

  2. Step 2

    Treatment phase

    The patient will receive the study medication, JK06, which is a 5T4 antibody drug conjugate. This medication is administered as a solution for infusion through an intravenous route.

    The administration schedule is every three weeks (Q3W). The dosage may vary as the study progresses through different phases, such as dose escalation and dose expansion.

  3. Step 3

    Monitoring and follow-up

    Throughout the study, the patient will attend regular clinic visits for monitoring. This includes assessments of safety, tolerability, and any side effects experienced.

    Additional tests may be conducted to evaluate the effectiveness of the treatment, such as imaging studies to measure tumor response.

  4. Step 4

    End of treatment

    After completing the treatment phase, the patient will undergo a final evaluation to assess the overall impact of the study medication.

    Follow-up visits may be scheduled to monitor long-term effects and gather additional data for the study.

Who can join the trial?

15 criteria

  • Must be at least 18 years old.
  • Must agree to a fresh tumor biopsy before treatment if 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 acceptable if it is the chosen method of birth control.
  • Men with partners who can have children must use effective barrier contraception during the study and for 90 days after stopping the study. They should also ensure their partners use contraception.
  • 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.
  • Use of hormones for breast cancer or other conditions is allowed. Certain medications for bone health are also permitted.
  • 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 and has spread or is advanced. Must have tried standard treatments or be unable to receive them.
  • For the expansion phase, must have specific types of cancer and have tried certain treatments. Must have no more than a specified number of 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.
  • Must have acceptable laboratory test results, including specific levels of albumin, platelets, hemoglobin, and other blood components.
  • Must provide a sample of a previous tumor, if available.

Who cannot join the trial?

10 criteria

  • Patients who have had another type of cancer treatment recently may not be eligible.
  • Individuals with certain other health conditions that could interfere with the study may be excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • People who have allergies to the study medication or its ingredients may be excluded.
  • Individuals who are unable to follow the study procedures or attend required visits may not be eligible.
  • Patients who are participating in another clinical trial at the same time may be excluded.
  • Individuals with a history of certain heart conditions may not be eligible.
  • Patients with uncontrolled infections or other serious illnesses may be excluded.
  • People who have had a recent surgery or are planning to have surgery during the study period may not be eligible.
  • Individuals with a history of substance abuse that could interfere with the study may be excluded.
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Investigated drugs

JK06 is an experimental medication being studied for its potential to treat patients with advanced or metastatic cancer that cannot be surgically removed. It is a type of drug known as an antibody-drug conjugate, which means it combines an antibody with a drug to specifically target and attack cancer cells. The study aims to determine the safety and tolerability of JK06 when given to patients through an intravenous infusion every three weeks. The trial will also explore the most effective dose of JK06 for further research.

What is already known about the treatment

JK06 – This medication is administered intravenously and is currently being studied in clinical trials for its safety and effectiveness in treating patients with unresectable, locally advanced, or metastatic cancer. It is in the early stages of research, specifically in Phase 1/2 trials, and is not yet widely recognized in medical literature. The main therapeutic indication for JK06 is to target and treat advanced forms of cancer that cannot be surgically removed. At the molecular level, JK06 is a 5T4 antibody-drug conjugate, which means it combines an antibody that specifically targets the 5T4 protein on cancer cells with a drug that can kill these cells. This medication falls under the pharmacological classification of antibody-drug conjugates, which are designed to deliver cytotoxic agents directly to cancer cells, minimizing damage to normal cells.

Investigated diseases

Unresectable, Locally Advanced or Metastatic Cancer – This term refers to cancer that cannot be removed through surgery due to its location or extent. "Locally advanced" indicates that the cancer has spread to nearby tissues or lymph nodes but not to distant parts of the body. "Metastatic" means the cancer has spread to distant organs or tissues. These cancers often grow and spread more aggressively, making them challenging to manage. The progression can vary widely depending on the type of cancer and its location. Treatment typically focuses on controlling the growth and spread of the cancer rather than curing it.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-512421-92-00Protocol codeJK06.1.01Estimated enrolment707 patientsSponsorSalubris Biotherapeutics Inc.

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