NCT05320588 · BiOneCure Therapeutics Inc.
A Study in Patients With Advanced Cancers
What this study is about
A first-in-human study using BIO-106 as a single agent and in combination with pembrolizumab in advanced cancers.
View original scientific description
A first-in-human study using BIO-106 as a single agent and in combination with pembrolizumab in advanced cancers.
Interventions
DRUG
BIO-106
BIO-106 is a novel antibody-drug conjugate (ADC) that targets the human trophoblast cell surface antigen 2 (Trop-2)
DRUG
Pembrolizumab
Programmed death receptor-1 (PD 1)-blocking antibody
Primary outcome measures
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1)
Time frame: 1 year
Escalation period
Incidence and nature of dose-limiting toxicities (DLTs) - (Phase 1)
Time frame: up to 21 days
Escalation period
Maximum tolerable dose (MTD) or a tolerated dose below MTD - (Phase 1)
Time frame: 1 year
Escalation period
Anti-tumor activity by objective response rate (ORR), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) - (Phase 2)
Time frame: 2 years
Expansion period
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 defin
Where
- Austin, Texas
- Houston, Texas
- Fairfax, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 19, 2022 · Source of record for eligibility and locations