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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

Sponsor: BiOneCure Therapeutics Inc. · Participants: 332 · Started: Mar 25, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05320588

Locations in the U.S.

TexasNEXT Oncology Austin, Austin
University of Texas MD Anderson Cancer Center, Houston
VirginiaNEXT 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.