Study on TransCon TLR7/8 Agonist With or Without Pembrolizumab for Advanced or Metastatic Solid Tumors

Sponsor: Ascendis Pharma Oncology Division A/S

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04799054

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This clinical trial is testing a new drug, TransCon TLR7/8 Agonist, alone or with pembrolizumab, to see if it is safe and effective for treating advanced or metastatic solid tumors. The study aims to find the best dose for future research.

Patient Parameters

Program Overview

TransCon TLR7/8 Agonist is an experimental drug being tested for treating advanced or metastatic solid tumors. This study will explore how well the drug works on its own or when combined with pembrolizumab. Participants will receive injections directly into the tumor every cycle. The main goals are to check the safety and find the best dose of TransCon TLR7/8 Agonist, either alone or with pembrolizumab.

Description

Toll-like receptors (TLRs) are proteins that help the immune system recognize and fight off harmful invaders. TransCon TLR7/8 Agonist is designed to be a long-lasting drug that targets these receptors to boost the immune response against tumors. It aims to keep high levels of the active ingredient, resiquimod, in the tumor area to fight cancer cells while minimizing side effects. This drug is expected to enhance the immune system's ability to attack cancer cells and work well with other treatments like pembrolizumab.

Eligibility Criteria

Inclusion Criteria

  • Must be at least 18 years old.
  • Have a confirmed diagnosis of advanced or metastatic solid tumors that cannot be cured with surgery or radiation.
  • Have tried standard treatments without success or have no standard treatment options available.
  • Have at least two measurable tumors.
  • Willing to have biopsies done.
  • Have good organ function based on recent tests.
  • Expected to live for more than 12 weeks.
  • Have a performance status score of 0, 1, or 2, indicating good overall health.
  • If previously treated with certain immune therapies, must wait at least 4 weeks since the last dose and show disease progression.
  • Any side effects from previous immune therapies must be resolved to a mild level.
  • Must agree to use effective birth control if of childbearing potential.

Exclusion Criteria

  • Previously treated with a TLR agonist (except for unrelated topical treatments).
  • Have had another active cancer in the last 2 years.
  • Have active autoimmune diseases, unless well controlled with hormone replacement.
  • Currently on systemic immunosuppressive treatment, unless on a low-dose steroid taper.
  • Women who are pregnant or breastfeeding.
  • Have had a live vaccine within 4 weeks before joining the study.
  • Have symptoms of cancer spread to the brain.
  • Have a bleeding disorder that increases risk from injections or biopsies.
  • Allergic to any part of TransCon TLR7/8 Agonist or pembrolizumab.
  • Have an uncontrolled infection.
  • Have had other cancer treatments within 4 weeks before starting the study.
  • Have significant heart disease or risk factors for heart rhythm problems.
  • Taking medications that affect heart rhythm within 14 days before joining the study.
  • Positive for HIV or have active hepatitis B or C.

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