Testing BIO-106 with pembrolizumab in patients with advanced cancers
A Phase 1/2 Study of BIO-106 As Monotherapy or In Combination With Pembrolizumab in Patients With Advanced Cancers (StarBridge-1)
This study is testing a new treatment called BIO-106, both alone and with pembrolizumab, to see if it can help people with advanced cancers that haven't responded to other therapies.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 332 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | BiOneCure Therapeutics Inc. Industry-sponsored |
| Drugs / interventions | pembrolizumab |
| Locations | 3 sites (Austin, Texas and 2 other locations) |
| Trial ID | NCT05320588 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with advanced solid tumors who have experienced disease progression after standard treatment or cannot tolerate standard therapies.
Not a fit: Patients with severe hypersensitivity to the study drugs or those with active infections or untreated CNS involvement may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced cancers that have limited existing therapies.
How similar studies have performed: Other studies using similar immunotherapy combinations have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Austin, Texas and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.