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Study of ACP-017 and Pembrolizumab for Patients with Advanced or Metastatic Cancer

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 people with advanced or spreading forms of cancer. The study is testing a new treatment called TransCon TLR7/8 Agonist, which is given as an injection directly into the tumor. This treatment is being tested alone and in combination with another medication called pembrolizumab, which is also known by the brand name KEYTRUDA. Pembrolizumab is given through an infusion into a vein. The purpose of the study is to understand how safe these treatments are and to find the best dose to use in future studies.

Participants in the study will receive either the TransCon TLR7/8 Agonist alone or together with pembrolizumab. The study will observe how the body responds to these treatments and will monitor any side effects. The study will also look at how well the treatments work in shrinking or controlling the cancer. The study is divided into different parts, with some participants receiving the treatment before surgery to see if it helps reduce the cancer.

The study will continue for several years, with regular check-ups and assessments to track the progress of the participants. The goal is to gather information that could lead to new treatment options for people with advanced cancer. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and well-being.

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 assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, performance status, and previous treatments.

    Participants must have a confirmed diagnosis of a solid tumor that cannot be treated with surgery or radiotherapy.

  2. Step 2

    Treatment plan

    The treatment involves the use of TransCon TLR7/8 Agonist and pembrolizumab. TransCon TLR7/8 Agonist is administered as a suspension for injection directly into the tumor.

    Pembrolizumab is given as an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.

  3. Step 3

    Dose escalation

    The study begins with a dose escalation phase to determine the safest and most effective dose of the medications.

    Participants receive increasing doses of the medications under close monitoring to assess any side effects.

  4. Step 4

    Dose expansion

    Once the optimal dose is identified, the dose expansion phase begins. This phase involves more participants receiving the established dose to further evaluate its effects.

    The focus is on understanding the treatment's impact on tumor size and progression.

  5. Step 5

    Regular monitoring

    Throughout the trial, regular monitoring is conducted to track the participant's health and response to treatment.

    This includes physical exams, blood tests, and imaging studies to assess tumor response.

  6. Step 6

    Completion and follow-up

    Upon completion of the treatment phase, participants enter a follow-up period to monitor long-term effects and overall survival.

    The study is estimated to conclude by June 2026, with ongoing assessments to ensure participant safety and gather comprehensive data.

Who can join the trial?

15 criteria

  • Must be at least 18 years old.
  • Must have an ECOG performance status of 0, 1, or 2. This is a scale that measures how well you can perform daily activities.
  • If previously treated with certain antibodies like anti-PD-1, anti-PDL1, or anti CTLA 4, there must be at least 4 weeks since the last dose and evidence of disease progression.
  • For certain head and neck cancers, must have a confirmed diagnosis and known HPV status. HPV is a virus that can affect cancer development.
  • For other HPV-associated cancers like anal, vulvar, cervical, penile, or vaginal cancers, must have a confirmed diagnosis and known HPV status.
  • For melanoma, must have a confirmed diagnosis and no prior radiotherapy or systemic therapy for melanoma.
  • For cutaneous squamous cell carcinoma, must have a confirmed diagnosis of locally advanced cancer.
  • If previously treated with an immune checkpoint inhibitor, any side effects must be resolved to a mild level or back to baseline.
  • Participants who can have children and are sexually active must agree to use effective birth control methods.
  • Must have a confirmed diagnosis of a solid tumor that cannot be treated with surgery or radiotherapy, except for certain groups in the study.
  • Must have progressed on or cannot tolerate standard treatment options, except for certain groups in the study.
  • Must have at least 2 measurable lesions, unless specified otherwise.
  • Must be willing to undergo biopsies, which are procedures to take small samples of tissue for testing.
  • Must have adequate organ function as shown by tests within 28 days before starting the study.
  • Must have a life expectancy of more than 12 weeks, as determined by the study doctor.

Who cannot join the trial?

7 criteria

  • Patients who have a different type of illness other than cancer cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not able to safely tolerate the study treatment cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have a serious infection or other serious medical condition cannot participate.
  • Patients who have previously received certain treatments that might interfere with the study cannot participate.
  • Patients who are unable to follow the study procedures or attend study visits cannot participate.
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Investigated drugs

  • TransCon TLR7/8 Agonist

    is an experimental medication being studied for its potential to treat advanced or metastatic solid tumors. It works by stimulating the immune system to recognize and attack cancer cells. This medication is being tested alone and in combination with another drug to determine its safety and the best dose to use in future studies.

  • Pembrolizumab

    is a medication that helps the immune system fight cancer. It is already used to treat various types of cancer by blocking a specific protein that prevents the immune system from attacking cancer cells. In this trial, pembrolizumab is being used in combination with TransCon TLR7/8 Agonist to see if the combination is more effective in treating solid tumors.

What is already known about the treatment

  • TransCon TLR7/8 Agonist

    This medication is administered through injection and is currently being studied in clinical trials for its potential use in treating cancer. It is in the early stages of research, specifically in Phase 1/2 trials, where its safety and optimal dosing are being evaluated. The main therapeutic indication is for locally advanced or metastatic solid tumor malignancies. At the molecular level, it works by activating the TLR7 and TLR8 receptors, which are part of the immune system, to enhance the body's immune response against cancer cells. It is classified as an immunotherapy agent.

  • Pembrolizumab

    This medication is administered via intravenous infusion and is an established treatment in oncology, widely documented in medical literature. It is primarily used for various types of cancer, including melanoma and lung cancer. Pembrolizumab works by blocking the PD-1 pathway, a mechanism that tumors use to evade the immune system, thereby allowing the immune system to better attack cancer cells. It belongs to the class of drugs known as immune checkpoint inhibitors.

Investigated diseases

Cancer – Cancer is a group of diseases characterized by the uncontrolled growth and spread of abnormal cells. It can develop in almost any organ or tissue, such as the lung, colon, breast, skin, bones, or nerve tissue. As cancer progresses, it can invade nearby parts of the body and spread to other areas through the blood and lymph systems. The progression of cancer varies depending on the type and location, with some cancers growing slowly and others rapidly. Symptoms can include lumps, abnormal bleeding, prolonged cough, unexplained weight loss, and changes in bowel movements. The exact cause of cancer is often unknown, but risk factors include genetic predisposition, lifestyle choices, and environmental exposures.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-517150-10-00Protocol codeTCTLR-101Estimated enrolment196 patientsSponsorAscendis Pharma Oncology Division A/S

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