First-in-Human Study of STX-478 Alone and with Other Cancer Treatments for Advanced Solid Tumors

Sponsor: Scorpion Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05768139

Provider View

This clinical trial is testing a new drug, STX-478, to see if it is safe and effective in treating advanced solid tumors, including certain types of breast cancer. The study will look at STX-478 alone and in combination with other cancer treatments.

Patient Parameters

Program Overview

This study is exploring a new treatment called STX-478 for people with advanced solid tumors that have a specific genetic mutation (PI3Kα). The trial is divided into three parts: the first part tests STX-478 by itself, the second part combines it with another drug called fulvestrant for hormone receptor-positive breast cancer, and the third part adds a CDK4/6 inhibitor (Ribociclib or Palbociclib) to the combination. Each part of the study includes a 28-day period to check participants' health before starting the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have an advanced solid tumor that cannot be removed by surgery and has spread or is locally advanced.
  • Have a recent or new tumor sample available for testing.
  • Have a tumor with a specific PI3Kα mutation.
  • Be 18 years or older.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate organ function as determined by specific medical tests.

Exclusion Criteria

  • Have had a different type of cancer within the last 2 years.
  • Have cancer that has spread to the brain or spine and is causing symptoms.
  • Have a tumor with certain other genetic mutations.
  • Have uncontrolled diabetes or type 1 diabetes.
  • Have previously been treated with certain cancer drugs, except in specific cases.
  • Have received any cancer treatment within 14 days or longer, depending on the drug's half-life, before starting the study treatment.
  • Have side effects from previous cancer treatments that have not improved, except for hair loss and nerve damage.
  • Have had radiation therapy within 14 days before starting the study treatment.
  • For certain study groups, have had previous treatments for metastatic breast cancer or specific hormone therapies, unless used as part of early treatment.

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