Study on LYT-200 Alone and in Combination with Chemotherapy or Tislelizumab for Advanced or Metastatic Solid Tumors

Sponsor: PureTech

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04666688

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, LYT-200, alone and in combination with chemotherapy or Tislelizumab, in patients with advanced or metastatic solid tumors.

Patient Parameters

Program Overview

This study is exploring a new treatment called LYT-200, which is being tested alone and in combination with other treatments like chemotherapy or Tislelizumab. The study aims to find out how safe and effective these treatments are for patients with advanced or metastatic solid tumors. The trial is divided into two parts: the first part focuses on finding the right dose, and the second part expands the study to more patients to further evaluate the treatment's effects.

Description

The study is divided into two phases. In the first phase, researchers will determine the safest dose of LYT-200, both alone and in combination with chemotherapy or Tislelizumab. This involves gradually increasing the dose to find the highest amount that can be given without causing severe side effects. In the second phase, the study will expand to include more patients to better understand how well the treatment works.

Participants will be monitored closely for any side effects and the effectiveness of the treatment. The study will involve regular health checks, blood tests, and imaging scans to track the progress of the cancer and the patient's overall health.

The goal is to find a new treatment option for patients with advanced or metastatic solid tumors who have limited options available.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and able to understand and sign a consent form.
  • Have advanced or metastatic cancer that cannot be removed by surgery.
  • No limit on previous cancer treatments received.
  • For certain cancer types, previous immunotherapy is allowed if it showed stable disease for at least 4 months.
  • Must have a life expectancy of more than 3 months.
  • Must be in good overall health with a performance status of 0 or 1.
  • Must be willing to undergo biopsies before and after treatment.
  • Must have measurable disease according to specific criteria.
  • Must have adequate blood cell counts and organ function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
  • Must have stopped previous cancer treatments at least 4 weeks before starting the study drug.
  • Must not have received a gemcitabine-containing regimen before.

Exclusion Criteria

  • Unable or unwilling to follow study requirements.
  • Have cancer of unknown origin.
  • Have active, uncontrolled bleeding or bleeding disorders.
  • Pregnant or breastfeeding women.
  • Participating in another clinical trial or receiving other investigational treatments.
  • Have active infections or other serious medical conditions that could interfere with the study.
  • Have a history of severe allergic reactions to similar drugs.
  • Have significant heart or lung diseases.
  • Have active autoimmune disorders requiring treatment.
  • Have severe pain or high calcium levels that are not controlled.
  • Have received an organ transplant or are undergoing dialysis.

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