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BIO-106 + Pembrolizumab for Advanced Cancer
Phase 1 & 2
Recruiting
Research Sponsored by BiOneCure Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients histologically or cytologically documented, locally advanced or metastatic solid tumor
Measurable disease as determined by RECIST v.1.1 or bone only disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new cancer drug, BIO-106, as a possible treatment for advanced cancer. This drug will be tested alone and in combination with another cancer drug, pembrolizumab.
Who is the study for?
This trial is for adults with advanced cancers that have worsened after standard treatment or those who can't handle or aren't allowed to get standard care. They should be able to perform daily activities with ease or with some limitation (ECOG status 0-1) and must have measurable cancer growth. People with HIV, hepatitis B/C, severe allergies to the drugs being tested, significant heart issues, active COVID-19, or untreated brain tumors cannot join.Check my eligibility
What is being tested?
The study is testing BIO-106 alone and combined with pembrolizumab in patients whose cancers have progressed significantly. Pembrolizumab is an established cancer drug while BIO-106 is new; their effects together are unknown and this first-in-human trial aims to discover how well they work against advanced solid tumors.See study design
What are the potential side effects?
Pembrolizumab may cause immune system reactions affecting organs, fatigue, skin rash, diarrhea among others. BIO-106's side effects are not fully known yet due to its experimental nature but could include similar immune-related conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced or has spread and was confirmed by a lab test.
Select...
My cancer can be measured by scans or is only in my bones.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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)
Incidence and nature of dose-limiting toxicities (DLTs) - (Phase 1)
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1)
+1 moreSecondary outcome measures
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 1)
Incidence of adverse event of special interest (AESI) - (Phase 2)
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2)
+3 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Group I: Single agent BIO-106Experimental Treatment1 Intervention
Escalating doses followed by expansion targeting advanced cancers
Group II: Combination BIO-106 plus pembrolizumabExperimental Treatment2 Interventions
Escalating doses followed by expansion targeting advanced cancers
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
BiOneCure Therapeutics Inc.Lead Sponsor
BiOneCure Clinical DevelopmentStudy DirectorBiOneCure Therapeutics Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have HIV, active hepatitis B, or hepatitis C.I have heart problems or a history of serious heart disease.I have not received treatment for tumors or cancer spread to my brain or spinal cord.I am currently infected with COVID-19.My cancer is advanced or has spread and was confirmed by a lab test.My cancer can be measured by scans or is only in my bones.I am fully active or can carry out light work.My cancer has worsened after standard treatment or I can't undergo standard treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Combination BIO-106 plus pembrolizumab
- Group 2: Single agent BIO-106
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What goals does this research hope to achieve?
"The primary goal of this long-term study is to document the rate of adverse events and serious adverse events during Phase 1. Additionally, researchers will be looking at anti-tumor activity, defined by objective response rate, disease control rate, duration of response, progression-free survival, and overall survival. These outcomes will also be measured during Phase 2 which is further broken down into an escalation period and expansion period."
Answered by AI
Are people still being signed up for this experiment?
"Yes, this study is still recruiting patients. The listing on clinicaltrials.gov shows that it was first posted on March 25th, 2022 and updated as recently as July 15th, 2022."
Answered by AI
How many individuals are being given this opportunity to participate in this clinical trial?
"That is correct. According to the information available on clinicaltrials.gov, this research is still looking for patients to enroll. The original posting was March 25th, 2022 and there have been updates as recently as July 15th, 2022. They are currently hoping to enroll 332 individuals from 3 different locations."
Answered by AI
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