Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
332 participants
INTERVENTIONAL
2022-03-25
2027-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Oral MBQ-167 in Participants With Advanced Breast Cancer
NCT06075810
A Study to Test BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) and BI 765179 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Cancer
NCT04958239
A Study of EBC-129 in Advanced Solid Tumours
NCT05701527
A Study to Test How BI 765063 and BI 770371 Are Taken up in Tumours of People With Different Types of Advanced Cancer Who Are Also Taking Ezabenlimab
NCT05068102
A Trial of BI 765063 Monotherapy and in Combination With BI 754091 in Patients With Advanced Solid Tumours
NCT03990233
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Single agent BIO-106
Escalating doses followed by expansion targeting advanced cancers
BIO-106
BIO-106 is a novel antibody-drug conjugate (ADC) that targets the human trophoblast cell surface antigen 2 (Trop-2)
Combination BIO-106 plus pembrolizumab
Escalating doses followed by expansion targeting advanced cancers
BIO-106
BIO-106 is a novel antibody-drug conjugate (ADC) that targets the human trophoblast cell surface antigen 2 (Trop-2)
Pembrolizumab
Programmed death receptor-1 (PD 1)-blocking antibody
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BIO-106
BIO-106 is a novel antibody-drug conjugate (ADC) that targets the human trophoblast cell surface antigen 2 (Trop-2)
Pembrolizumab
Programmed death receptor-1 (PD 1)-blocking antibody
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
BiOneCure Therapeutics Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
BiOneCure Clinical Development
Role: STUDY_DIRECTOR
BiOneCure Therapeutics Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
NEXT Oncology Austin
Austin, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
NEXT Oncology Virginia
Fairfax, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
StarBridge-1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.