Study on the Effectiveness of Tigilanol Tiglate Injections for Soft Tissue Sarcoma

Sponsor: QBiotics Group Limited

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05755113

Provider View

This clinical trial is testing a new treatment called tigilanol tiglate, which is injected directly into tumors, to see if it can help treat advanced or spreading soft tissue sarcoma in the arms, legs, or body wall.

Patient Parameters

Program Overview

The purpose of this study is to find out if injecting a drug called tigilanol tiglate directly into tumors can help destroy them in patients with advanced or metastatic soft tissue sarcoma. The study will also look at how safe and tolerable the treatment is, and how the body processes the drug after injection. Researchers will explore how the treatment affects the tumor environment, the immune response, and the likelihood of the cancer returning.

Description

The main goal of this study is to see if tigilanol tiglate injections can effectively destroy tumors in patients with advanced soft tissue sarcoma. Researchers will also assess the safety and tolerability of these injections and how the drug is absorbed and processed by the body. Additionally, the study will explore how the treatment affects the tumor's surroundings, the body's immune response, and the chances of the cancer coming back.

Eligibility Criteria

Inclusion Criteria

  • Must be willing and able to provide written consent and follow study requirements.
  • Must be 18 years or older.
  • Must have advanced or metastatic soft tissue sarcoma in the body wall or limbs that can be injected directly, confirmed by medical tests. Tumors on the scalp may also be considered.
  • Must have a performance status score of 2 or less, indicating they are able to carry out light work.
  • Must have a life expectancy of more than 12 weeks.
  • Must have adequate kidney and liver function as determined by the study doctor.
  • Women who can become pregnant must have a negative pregnancy test before starting the study, agree to use effective birth control during the study and for 30 days after, and must not be breastfeeding.
  • Men with partners who can become pregnant must agree to use effective birth control during the study and for 30 days after, and must not donate sperm during this time.

Exclusion Criteria

  • Planning to receive other treatments or radiation to the tumors intended for injection within 28 days before starting the study or during the study.
  • Have a tumor for injection that is too close to major blood vessels.
  • Have received other experimental treatments or devices without a 28-day break before starting the study.
  • Have received other cancer treatments without a 28-day break before starting the study.
  • Have had major surgery within 28 days before starting the study or expect to need major surgery during the study.
  • Have active brain cancer or cancer in the brain's lining, unless previously treated and stable.
  • Have bleeding disorders or are on blood thinners that make injections unsafe.
  • Have severe allergies to tigilanol tiglate or similar substances.
  • Are not suitable for the study due to other medical or psychiatric conditions, as determined by the study doctor.

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