Study on TAK-500 With or Without Pembrolizumab for Adults with Advanced or Metastatic Solid Tumors

Sponsor: Takeda

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05070247

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, TAK-500, given alone or with pembrolizumab, in adults with certain advanced or metastatic solid tumors. Participants may receive the treatment for up to a year, with the possibility of continuing if they benefit from it.

Patient Parameters

Program Overview

The study is exploring a new treatment called TAK-500, which is being tested alone and in combination with another drug, pembrolizumab, in adults with certain advanced or metastatic solid tumors. The main goals are to see if TAK-500 is safe and to understand its effects on tumors. Participants may receive TAK-500 for up to one year, and they can continue if they are benefiting from the treatment and their doctor approves.

Description

This study is testing a new drug called TAK-500, both by itself and with pembrolizumab, in adults with advanced or metastatic solid tumors. The study will be conducted in two phases: Dose Escalation and Dose Expansion. About 313 participants will be involved, with 82 in the Dose Escalation Phase and 231 in the Dose Expansion Phase. The Dose Escalation Phase will help determine the best dose of TAK-500 to use in the Dose Expansion Phase. Participants will be divided into different groups to receive either TAK-500 alone or with pembrolizumab, depending on their specific type of cancer and previous treatments. The study will take place at multiple locations worldwide. Participants who show clinical benefits may continue treatment beyond one year if approved by the study sponsor.

Eligibility Criteria

Inclusion Criteria

  • Adults with a performance status of 0 to 1, meaning they are fully active or have some restrictions in physically strenuous activity but are ambulatory.
  • Have certain types of advanced or metastatic solid tumors, such as gastroesophageal adenocarcinoma, pancreatic adenocarcinoma, liver cancer, non-small cell lung cancer, head and neck cancer, mesothelioma, triple-negative breast cancer, kidney cancer, and nasopharyngeal cancer.
  • Have tried standard treatments that did not work or were intolerant to them.
  • Have at least one measurable tumor that can be tracked using standard criteria.
  • Have adequate blood cell counts and organ function, including liver and kidney function.
  • Have a heart function of more than 50% as measured by specific tests.
  • For liver cancer patients, have a Child-Pugh score of 7 or less.
  • Have recovered from any significant side effects of previous treatments to a mild level.
  • Have not received certain types of cancer treatments within a specified time before starting the study.

Exclusion Criteria

  • Have had serious heart problems, such as heart failure or heart attack, within the last 6 months.
  • Have a prolonged QT interval on an ECG.
  • Have low blood pressure requiring intervention.
  • Have low oxygen levels in the blood.
  • Have used certain immune system drugs within the last 6 months.
  • Have active lung diseases or severe lung conditions.
  • Have active hepatitis B or C infections.
  • Have a history of liver-related brain issues.
  • Have significant fluid buildup in the abdomen requiring drainage.
  • Have received other cancer treatments or investigational drugs recently.
  • Have used radiation therapy recently, especially to the lungs.
  • Are using systemic steroids or immunosuppressive therapy, with some exceptions.
  • Have had a stem cell or organ transplant.
  • For those in the TAK-500 and pembrolizumab group, have a known intolerance to pembrolizumab or similar drugs.

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