Study on the Effects of CT3001 in Patients with Advanced Solid Tumors

Sponsor: Crossignal Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06598007

Provider View

This clinical trial is testing a new drug, CT3001, to see if it is safe and effective for patients with advanced solid tumors, such as colorectal and pancreatic cancer, who have no other treatment options.

Patient Parameters

Program Overview

This study is exploring a new treatment called CT3001 for patients with advanced solid tumors, including colorectal and pancreatic cancer. The study is divided into two phases. Phase 1 will focus on finding the right dose and checking the safety of CT3001 in patients who have no other treatment options. Phase 2a will expand the study to see how well CT3001 works in patients with advanced colorectal or pancreatic cancer.

Description

The study aims to test a new drug, CT3001, for treating advanced solid tumors like colorectal and pancreatic cancer. Traditional treatments like surgery, chemotherapy, and radiation often have limitations, especially for advanced cases. CT3001 is a new type of treatment that targets specific proteins in cancer cells to help the body's immune system fight the cancer more effectively.

The study will take place in two phases. Phase 1 will involve a small group of patients to determine the safest dose of CT3001. Once the best dose is found, Phase 2a will involve more patients to see how well the drug works in treating colorectal and pancreatic cancers.

Participants will go through a screening process to ensure they meet the study criteria. They will then receive CT3001 in cycles, with regular monitoring to check for side effects and effectiveness. The study will also look at changes in specific cancer markers to assess the drug's impact.

The study will take place at multiple sites in the United States and China, with about 18 to 36 participants in Phase 1 and around 42 participants in Phase 2a.

Eligibility Criteria

Inclusion Criteria

  • Able to understand the study and willing to follow all procedures.
  • Aged 18 years or older.
  • Have advanced solid tumors that cannot be treated with standard therapies.
  • Have measurable disease that can be tracked.
  • Life expectancy of at least 3 months.
  • Good overall health with a performance status of 0 or 1.
  • Adequate blood, liver, and kidney function.
  • Willing to use effective contraception during the study and for 3 months after the last dose.

Exclusion Criteria

  • Currently receiving other cancer treatments.
  • Have used any investigational drugs recently.
  • Have severe or uncontrolled health conditions.
  • Pregnant or nursing women, or those planning to become pregnant.
  • Recent major surgery or significant injury.
  • Heart conditions that increase risk of complications.
  • Mental or geographical conditions that may interfere with the study.
  • Recent blood donation or significant blood loss.
  • Severe allergies or reactions to the study drug.
  • Recent vaccination with a live vaccine.
  • Use of certain medications that affect the study drug.
  • Positive test for hepatitis B, hepatitis C, or HIV, unless under control with treatment.

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