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A study of DT-7012 alone and in combination with pembrolizumab in patients with advanced solid tumors

Verified siteInvestigationalNo placebo
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What is this trial about?

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

This study is looking at cancer, specifically certain types of advanced solid tumors. A solid tumor is a mass of cancer cells that forms in body tissues or organs. The treatment being tested is DT-7012, which is an experimental medication. The study will test DT-7012 on its own and also in combination with pembrolizumab, which is an immune checkpoint inhibitor. An immune checkpoint inhibitor is a type of medication that helps the body's immune system recognize and fight cancer cells more effectively. The purpose of this study is to find the highest dose of DT-7012 that can be given safely and to assess how safe and well-tolerated it is when given alone and when combined with pembrolizumab.

The study is divided into different parts called cohorts, which are groups of participants. Some participants will receive DT-7012 alone to help determine the best dose, while others will receive it together with pembrolizumab. The medication will be given through intravenous infusion, which means it will be delivered directly into a vein through a needle. Throughout the study, doctors will monitor participants for any side effects or unwanted reactions to the treatment. They will also check how the medication moves through the body and how long it stays in the bloodstream.

In addition to safety monitoring, the study will evaluate whether the treatment has any effect on the cancer. This includes checking if tumors shrink, stay the same size, or stop growing for a period of time. The study will involve multiple visits where participants will undergo various tests and examinations to track their health and the response of their cancer to the treatment. This is an early phase study designed to gather important information about how DT-7012 works in people with advanced solid tumors.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment period with DT-7012

    Your treatment will begin with DT-7012, which is an investigational medication being tested in this clinical trial.

    The medication will be administered through intravenous infusion, which means it will be delivered directly into your vein through a drip.

    The medication is provided as a concentrate for solution for infusion, which will be prepared and given to you by medical staff.

    The specific dose you receive will be determined based on the study phase you are enrolled in. The trial is designed to find the maximum safe dose that can be given.

  2. Step 2

    Monitoring for side effects during dose observation period

    During the initial treatment period, you will be closely monitored for any dose-limiting toxicities, which are side effects that are serious enough to require a dose adjustment or treatment pause.

    The medical team will track any treatment-emergent adverse events, which are any health problems that occur after your treatment starts.

    Special attention will be given to adverse events of special interest, which are specific side effects that are particularly important to monitor in this trial.

    Any serious adverse events or side effects that might lead to stopping treatment will be carefully documented and managed.

  3. Step 3

    Blood sample collection for drug level measurement

    Blood samples will be collected at specific times to measure how the medication moves through your body.

    These samples will help determine the maximum concentration of the drug in your blood and the time it takes to reach that maximum level.

    This information, known as pharmacokinetics, helps understand how your body processes the medication.

  4. Step 4

    Tumor response assessment

    Your tumor will be assessed using imaging scans to determine how it responds to treatment.

    The medical team will measure whether your tumor shrinks, stays the same size, or grows.

    This assessment will determine the overall response rate, which indicates whether the treatment is working.

    The disease control rate will also be measured, which includes cases where the tumor shrinks or remains stable.

    If your tumor responds to treatment, the duration of response will be tracked to see how long the benefit lasts.

    If your disease remains stable, the duration of stable disease will be recorded.

  5. Step 5

    Combination treatment phase with pembrolizumab

    Depending on which part of the trial you are enrolled in, you may receive DT-7012 in combination with pembrolizumab.

    Pembrolizumab is an immune checkpoint inhibitor, which is a type of medication that helps your immune system fight cancer cells.

    If you receive combination treatment, both medications will be administered, and you will continue to be monitored for safety and effectiveness.

    The combination treatment phase will follow similar monitoring procedures as the single medication phase.

  6. Step 6

    Ongoing safety monitoring and assessments

    Throughout the trial, continuous monitoring will occur to track your safety and how well the treatment is working.

    Any side effects or health changes will be documented and managed appropriately.

    Regular assessments will be performed to evaluate your overall condition and treatment response.

    Treatment may be adjusted or discontinued based on how you respond or if significant side effects occur.

Who can join the trial?

4 criteria

  • You must have a confirmed solid tumour, which is a type of cancer that forms a mass or lump, confirmed through a biopsy, which means a small sample of tissue was taken and examined under a microscope
  • You must be at least 18 years old or older at the time you sign the consent form to participate in the study
  • You must have evidence of your cancer visible on imaging tests such as scans. For some parts of the study, your cancer needs to be measurable, which means the doctors can track its size using these scans
  • You must have an ECOG performance status of 0 or 1. This is a score that measures how well you can perform daily activities. A score of 0 means you are fully active and able to do all activities without restriction. A score of 1 means you cannot do heavy physical work but can do light activities and take care of yourself

Who cannot join the trial?

3 criteria

  • The study materials do not provide specific exclusion criteria information at this time
  • If you are interested in this clinical trial, the research team will need to review your complete medical history to determine if you can participate
  • General factors that typically prevent participation in cancer clinical trials may include having certain other medical conditions, taking specific medications, or having recent treatments, but the exact criteria for this study are not listed in the available information
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Investigated drugs

  • DT-7012

    is an investigational medication being studied in this trial. It is being tested both on its own and when given together with another cancer treatment. The purpose is to find the right dose and to see how safe it is for people with advanced solid tumors.

  • Pembrolizumab

    is a type of cancer treatment called an immune checkpoint inhibitor. It works by helping your body's own immune system recognize and fight cancer cells. In this trial, it is being used in combination with DT-7012 to see how well the two medications work together.

What is already known about the treatment

  • DT-7012

    DT-7012 is an experimental cancer treatment currently being studied in early-phase clinical trials for patients with advanced solid tumors. This medication is being tested both alone and in combination with pembrolizumab, which is a type of immune checkpoint inhibitor that helps the body's immune system fight cancer cells. The trial is designed to find the safest and most effective dose of DT-7012 and to evaluate how well it works when given together with immunotherapy. While the exact way DT-7012 works at the cellular level is still being investigated, it represents a potential new option for treating various types of cancer that have spread or are difficult to treat with standard therapies.

  • Pembrolizumab

    Pembrolizumab is an approved cancer medication given through an intravenous infusion (directly into a vein) that is widely used to treat various types of cancer. It belongs to a class of drugs called immune checkpoint inhibitors, specifically targeting a protein called PD-1 on immune cells, which allows the body's own immune system to recognize and attack cancer cells more effectively. This medication works by blocking the interaction between PD-1 and its binding partners, essentially removing the "brakes" that prevent immune cells from fighting tumors. Pembrolizumab is currently approved for treating several cancer types and is being studied in this trial in combination with DT-7012 to potentially improve treatment outcomes for patients with advanced solid tumors.

Investigated diseases

Cancer – Cancer is a group of diseases characterized by the uncontrolled growth and spread of abnormal cells in the body. Normal cells grow, divide, and die in an orderly way, but cancer cells continue to grow and divide without stopping. These abnormal cells can form lumps or masses called tumors, which can invade nearby tissues. Some cancer cells can break away from the original tumor and travel through the blood or lymph system to other parts of the body, a process called metastasis. Not all tumors are cancerous; benign tumors do not spread to other parts of the body. The progression of cancer varies depending on the type and location, but generally involves stages from early localized growth to advanced spread throughout the body.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2025-523758-15-00Protocol codeDT-7012-CLI-001Estimated enrolment125 patientsSponsorDomain Therapeutics Australia Pty Limited

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