Study on BIO-106 Alone and with Pembrolizumab for Advanced Cancers

Sponsor: BiOneCure Therapeutics Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05320588

Provider View

This clinical trial is testing a new drug, BIO-106, both by itself and with another drug called pembrolizumab, to see if it is safe and effective for treating advanced cancers.

Patient Parameters

Program Overview

This study is the first time BIO-106 is being tested in humans. It aims to find the safest dose of BIO-106, both alone and with pembrolizumab, for treating advanced cancers. The study will also look at how well these treatments work in patients with advanced solid tumors who have limited treatment options.

Description

This clinical trial is divided into two phases. In Phase 1, researchers will determine the safest dose of BIO-106 that can be used alone or with pembrolizumab. This phase will help identify the right dose to use in Phase 2. In Phase 2, the study will evaluate how effective these treatments are in shrinking tumors in patients with advanced solid cancers that have not responded well to other treatments. The study is open-label, meaning both the researchers and participants know which treatment is being given. Participants will receive multiple doses of BIO-106, and their health will be closely monitored to assess the treatment's safety and effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced or metastatic solid tumor cancer.
  • Cancer must have worsened after standard treatments, or the patient cannot tolerate or is not suitable for standard treatments.
  • Have measurable cancer that can be tracked using standard criteria or have cancer in the bones only.
  • 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.

Exclusion Criteria

  • Have a history of severe allergic reactions to any of the study drugs, including pembrolizumab or similar drugs.
  • Have heart problems or a history of significant heart disease.
  • Have active infections like HIV, hepatitis B, hepatitis C, or COVID-19.
  • Have untreated cancer that has spread to the brain or spinal cord.
  • Other specific criteria may apply as defined by the study protocol.

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