Study on CBX-12 for Patients with Advanced or Metastatic Solid Tumors

Sponsor: Cybrexa Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04902872

Provider View

This clinical trial is testing a new drug, CBX-12, to see if it is safe and effective for treating advanced or metastatic solid tumors that have not responded to previous treatments.

Patient Parameters

Program Overview

This study is the first time CBX-12 is being tested in humans. It is a Phase 1/2 trial that will take place at multiple centers. The study aims to find the safest dose of CBX-12 and understand how the body processes the drug in patients with advanced or metastatic solid tumors that have not responded to other treatments.

Description

In Phase 1 of the study, researchers will test different dosing schedules of CBX-12 to determine the safest and most effective way to administer the drug. Participants will receive CBX-12 in one of several schedules: daily for 5 days every 3 weeks, daily for 3 days every 3 weeks, once a week, or once every 3 weeks. After each group of participants completes their treatment, a team of researchers will review the safety data to decide on the best dose for Phase 2.

Once the best dose is determined, Phase 2 will begin, where more participants will receive CBX-12 to further evaluate its effectiveness and safety.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of an advanced or metastatic solid tumor that has worsened after at least one previous treatment or for which no approved treatment exists.
  • Have measurable disease according to specific medical criteria.
  • Provide a tumor sample from a biopsy taken during the screening period and after the most recent treatment.
  • Agree to have another biopsy during treatment if it is safe to do so.

Exclusion Criteria

  • Have received chemotherapy, biologic agents, investigational drugs, or radiation therapy within 3 weeks before starting CBX-12. This period may be reduced to 2 weeks for certain types of radiation or investigational drugs with approval.
  • Have taken small-molecule kinase inhibitors or hormonal agents within 14 days before starting CBX-12.
  • Are currently receiving any other cancer treatments or investigational drugs.
  • Have significant other medical conditions.
  • Have primary brain tumors or active cancer spread to the brain or spinal cord. Patients with stable brain metastases may participate with approval.

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