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Study of ASP1570 Alone or with Pembrolizumab for Adults with Advanced Solid Tumors

Verified siteRegistered 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 treatments for advanced solid tumors, which are types of cancer that have spread and are difficult to remove surgically. The study will explore the effects of a new medication called ASP1570, both when used alone and in combination with another drug called pembrolizumab, which is also known by its brand name, Keytruda. These treatments aim to assess their safety and how well they are tolerated by patients.

The purpose of the study is to determine the best dosage and treatment plan for ASP1570, whether it is used by itself or alongside pembrolizumab. Participants in the study will receive either the new medication or a combination of the new medication and pembrolizumab. Some participants may receive a placebo, which is a substance with no active medication. The study will monitor participants over time to observe any changes in their health, including side effects and how their tumors respond to the treatment.

Throughout the study, participants will undergo regular health checks, including blood tests and other assessments, to ensure their safety and to gather information on how the treatments are working. The study is expected to continue until the end of 2027, with recruitment starting in 2024. This research is important for understanding how these treatments can help people with advanced solid tumors and to find the most effective way to use them.

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

    Initial treatment phase

    The study begins with the administration of ASP1570 as a tablet. This medication is taken orally. The specific dosage and frequency will be determined by the study team based on individual needs and responses.

    During this phase, regular monitoring of health status is conducted through laboratory tests and physical examinations to ensure safety and tolerability.

  2. Step 2

    Combination treatment phase

    If eligible, the treatment may include a combination of ASP1570 and pembrolizumab. Pembrolizumab is administered as an intravenous infusion. The frequency and duration of this combination therapy will be determined by the study team.

    Regular assessments are performed to monitor the body's response to the combination therapy, including changes in laboratory tests and vital signs.

  3. Step 3

    Monitoring and follow-up

    Throughout the study, participants undergo regular evaluations to assess the effectiveness of the treatment. This includes imaging tests to measure tumor response and blood tests to monitor overall health.

    Participants are required to report any side effects or changes in health to the study team promptly.

  4. Step 4

    End of treatment

    Upon completion of the treatment phase, a final assessment is conducted to evaluate the overall response to the therapy.

    Participants may be required to attend follow-up visits to monitor long-term effects and gather additional data for the study.

Who can join the trial?

18 criteria

  • The participant must provide written consent to join the study, which is approved by an ethics committee.
  • The participant must be an adult according to local laws.
  • The participant must have a type of cancer called locally-advanced or metastatic solid tumor, confirmed by medical records or a biopsy.
  • The participant must have at least one measurable tumor, as determined by specific medical criteria.
  • The participant must have tried standard treatments and either not responded, is not eligible for them, or has chosen not to continue with them.
  • The participant must have a performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
  • The participant's last cancer treatment must have been at least 21 days before starting the study treatment.
  • If the participant had radiation therapy, it must have been completed at least 2 weeks before starting the study treatment.
  • Any side effects from previous treatments must have improved to a mild level or returned to the participant's normal state at least 14 days before starting the study treatment.
  • The participant must have adequate organ function, as shown by specific blood test results.
  • The participant must not have a blood clotting time that is too long and should not be on blood-thinning medication.
  • Female participants must not be pregnant and must agree to use birth control during the study and for a specified time after the study ends.
  • Female participants must agree not to breastfeed during the study and for a specified time after the study ends.
  • Female participants must agree not to donate eggs during the study and for a specified time after the study ends.
  • Male participants with female partners who can become pregnant must agree to use birth control during the study and for a specified time after the study ends.
  • Male participants must agree not to donate sperm during the study and for a specified time after the study ends.
  • Male participants with pregnant partners must agree to remain abstinent or use a condom during the study and for a specified time after the study ends.
  • The participant must agree not to join another study while participating in this one.
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Investigated drugs

  • ASP1570

    is an investigational medication being studied for its potential to treat advanced or metastatic solid tumors. It is being tested both as a standalone treatment and in combination with another medication to assess its safety and how well it is tolerated by patients.

  • Pembrolizumab

    is a medication that helps the immune system fight cancer. It is used in this study in combination with ASP1570 to see if the two medications together can be more effective in treating solid tumors. Pembrolizumab is already used in the treatment of various types of cancer.

What is already known about the treatment

  • ASP1570

    This medication is administered intravenously and is currently being studied in clinical trials for its safety and effectiveness in treating advanced solid tumors. It is in the early stages of research, with limited information available in medical literature. ASP1570 is being investigated for its potential to inhibit tumor growth by targeting specific pathways involved in cancer cell survival. It falls under the pharmacological classification of investigational cancer therapies.

  • Pembrolizumab

    This medication is administered intravenously and is widely used in medicine for treating various types of cancer, including advanced solid tumors. It is well-documented in medical literature and is approved for use in several countries. Pembrolizumab works by blocking a protein called PD-1, which helps the immune system recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor.

Investigated diseases

Advanced Solid Tumors – Advanced solid tumors refer to a group of cancers that form solid masses in various organs or tissues and have progressed to a more severe stage. These tumors can occur in different parts of the body, such as the lungs, liver, or pancreas, and are characterized by their ability to grow and spread to other areas. As the disease advances, the tumors may invade nearby tissues and organs, potentially leading to a range of symptoms depending on their location. The progression of advanced solid tumors often involves the growth of the primary tumor and the potential for metastasis, where cancer cells spread to distant sites. This stage of cancer is typically more challenging to manage due to the complexity and extent of tumor spread.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-505084-37-00Protocol code1570-CL-0101Estimated enrolment310 patientsSponsorAstellas Pharma Global Development Inc.

sourced from the EU Clinical Trials Register and site verification

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