Testing BIO-106 with pembrolizumab in patients with advanced cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, first-in-human study evaluating the safety and efficacy of BIO-106, both as a standalone treatment and in combination with pembrolizumab, for patients with advanced solid tumors. The study is divided into two phases: Phase 1 focuses on determining the maximum tolerated dose of BIO-106, while Phase 2 assesses the preliminary effectiveness of the treatment regimens. Patients with locally advanced or metastatic solid tumors that have progressed after standard treatments are eligible for participation.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Patients histologically or cytologically documented, locally advanced or metastatic solid tumor.
* Disease progression confirmed by imaging or other objective evidence after having received standard treatment; or patients with refractory solid tumors who cannot tolerate standard treatment or have contraindications to standard treatment.
* Measurable disease as determined by RECIST v.1.1 or bone only disease.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Key Exclusion Criteria:

* History of severe hypersensitivity to any ingredient of the study drug(s), including pembrolizumab or other monoclonal antibody.

Impaired cardiac function or history of clinically significant cardiac disease

* Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
* Active SARS-CoV-2 infection.
* Untreated central nervous system (CNS), epidural tumor or metastasis, or brain metastasis.

Other protocol defined inclusion/exclusion criteria may apply.

Where it's running

• NEXT Oncology Austin
  Austin, Texas, United States Recruiting
• University of Texas MD Anderson Cancer Center
  Houston, Texas, United States Recruiting
• NEXT Oncology Virginia
  Fairfax, Virginia, United States Recruiting

Study contacts

• Study coordinator: BiOneCure Therapeutics Inc.
• Email: Starbridge-1@bionecure.com
• Phone: (240) 912-9101

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.