No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
332 (estimated)
Sponsor
BiOneCure Therapeutics Inc. · Industry
Who this trial is looking for
This trial is looking for patients with advanced cancers who have tried standard treatments without success. Participants will receive the study drug BIO-106, either alone or with another treatment called pembrolizumab.
Are You a Good Fit for This Trial?
You may be able to join if
I have a confirmed diagnosis of an advanced solid tumor
My cancer has worsened after standard treatments
I have measurable disease as assessed by imaging
My performance status is ECOG 0 or 1
You may not be able to join if
I have a severe allergy to any ingredient in the study drugs
I have significant heart problems
I have HIV or active hepatitis B or C
I have an active SARS-CoV-2 infection
I have untreated brain tumors or metastases
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
A first-in-human study using BIO-106 as a single agent and in combination with pembrolizumab in advanced cancers.
Trial Locations
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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 st…
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.
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