Open-Label Study of SPH4336 for Advanced Liposarcomas

Sponsor: Shanghai Pharma Biotherapeutics USA Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05580588

Provider View

This clinical trial is testing a new drug, SPH4336, to see if it is safe and effective in treating patients with advanced liposarcomas, a type of cancer. The study will also look at how the drug is processed in the body.

Patient Parameters

Program Overview

This study is testing a new cancer treatment called SPH4336, which is a type of drug that blocks certain enzymes to stop cancer cells from growing. The trial is open-label, meaning all participants will know they are receiving the drug, and it will take place at multiple locations. The main goals are to check the safety of SPH4336, understand how it behaves in the body, and see if it can help shrink tumors in patients with specific types of liposarcomas.

Description

This clinical trial is for patients with a type of cancer called liposarcoma, which affects fat cells. The study is testing a drug called SPH4336, which is taken as a tablet once a day. The drug works by blocking certain enzymes that help cancer cells grow. The trial will start with a safety phase involving the first 10 participants to ensure the drug is safe. If more than 2 people experience serious side effects, the study will be stopped.

Participants will have their tumors checked every 6 weeks for the first 36 weeks, and then every 12 weeks after that, to see if the drug is working. Blood samples will be taken to understand how the drug is processed in the body. Participants will need to provide a sample of their tumor tissue before starting the treatment to confirm the type of cancer and check for specific markers. The first 10 participants will also have a second tumor sample taken after starting the treatment to see how the drug affects the cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a confirmed diagnosis of advanced liposarcoma.
  • Must have a good overall health status (ECOG score of 0 or 1).
  • Must not have had more than 3 previous treatments for their cancer.
  • Must show signs that the cancer is getting worse, such as new tumors or growth of existing tumors.
  • Must have measurable cancer that can be tracked.
  • Must have certain blood counts and organ functions within normal limits.
  • Must agree to use effective birth control during the study and for 3 months after.
  • Must be willing to provide a tumor sample before starting the study and, for the first 10 participants, another sample after starting the treatment.

Exclusion Criteria

  • Have previously been treated with a similar type of drug (CDK4/6 inhibitor).
  • Have a tumor that does not have the specific marker needed for the study.
  • Have had recent cancer treatments or major surgery.
  • Need certain medications that could interfere with the study drug.
  • Have cancer that has spread to the brain or spinal cord, unless treated and stable.
  • Have another type of cancer unless it has been in remission for at least 2 years.
  • Have active infections or certain viral infections like HIV or hepatitis.
  • Have serious heart problems or other medical conditions that could pose a risk.
  • Are pregnant or breastfeeding.
  • Have digestive issues that could affect how the drug is absorbed.

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