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A Study in Patients With Advanced Cancers
RecruitingPhase 1/2
A Phase 1/2 Study of BIO-106 As Monotherapy or In Combination With Pembrolizumab in Patients With Advanced Cancers (StarBridge-1)
Who can join
Ages 18 and older · All sexes
Full eligibility 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.
About the study
A first-in-human study using BIO-106 as a single agent and in combination with pembrolizumab in advanced cancers.
What is being tested
- BIO-106 (drug)
- Pembrolizumab (drug)
Sponsor: BiOneCure Therapeutics Inc. · Participants: 332 · Started: Mar 25, 2022
Contact the study team
- BiOneCure Therapeutics Inc. · Phone: (240) 912-9101
Official record on ClinicalTrials.gov — NCT05320588
Locations in the U.S.
| Texas | NEXT Oncology Austin, Austin University of Texas MD Anderson Cancer Center, Houston |
| Virginia | NEXT Oncology Virginia, Fairfax |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.