Study on CBP-1019 for Patients with Advanced Solid Tumors

Sponsor: Coherent Biopharma (Hefei) Co., Ltd.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05830097

Provider View

This clinical trial is testing a new drug, CBP-1019, to see if it is safe and effective for treating advanced solid tumors in adults. The study aims to find the best dose for future research.

Patient Parameters

Program Overview

The main goal of this study is to evaluate the safety and potential effectiveness of a new drug called CBP-1019 in adults with advanced solid tumors. Researchers want to determine the best dose to use in future studies. The trial is divided into two parts: the first part focuses on finding a safe dose, while the second part looks at how well the drug works in specific types of tumors.

Description

This study is divided into two phases: Phase Ia and Phase Ib/II. In Phase Ia, researchers will test different doses of CBP-1019 to find the safest and most tolerable dose for patients with advanced solid tumors who have not responded to standard treatments. This phase will help determine the maximum dose that can be safely given and the recommended dose for the next phase. Patients will be monitored for any side effects over a 28-day period.

In Phase Ib/II, patients will receive the recommended dose of CBP-1019 every two weeks. Researchers will evaluate how well the drug works by measuring the response of the tumors, how long patients remain free of disease progression, and other factors. The study will also explore the relationship between tumor response and specific receptors. Safety information will continue to be collected during this phase.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent before any study procedures.
  • Men or women aged 18 years or older.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Expected to live at least 3 more months, according to the study doctor.
  • Must have a confirmed diagnosis of advanced solid tumor, such as lung, pancreatic, colorectal, esophageal, or breast cancer.
  • Tumor tissue must be available for specific receptor testing, especially for certain dose levels.
  • Must have received prior standard treatment for their cancer type or be unable to tolerate or benefit from standard treatment.
  • Must show disease progression after the last anti-tumor treatment.
  • Must have at least one measurable tumor, with specific conditions for certain dose levels.
  • Must have adequate bone marrow and organ function, as shown by specific blood test results.
  • Women of childbearing potential and men with partners of childbearing potential must use effective contraception during the study and for a specified period after the last dose of CBP-1019.

Exclusion Criteria

  • Known allergy to CBP-1019 or its components.
  • Have another active cancer within the last 5 years, except for certain early-stage cancers considered cured.
  • Have untreated or unstable brain metastases or cancer in the brain lining.
  • Have uncontrolled fluid buildup around the lungs, heart, or abdomen.
  • Have not completed the required waiting period after previous cancer treatments.
  • Have unresolved side effects from previous cancer treatments, except for hair loss and fatigue.
  • Have a fever over 38.5°C without a known cause.
  • Have active hepatitis B infection with high viral load.
  • Have severe heart failure or significant vascular diseases.
  • Have had active gastrointestinal ulcers or related issues within the last 6 months.
  • Have a history of autoimmune disease, immune deficiency, or organ transplant.

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