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Monoclonal Antibody
BI-1206 + Pembrolizumab for Advanced Cancer
Phase 1 & 2
Recruiting
Led By Carneiro, PhD
Research Sponsored by BioInvent International AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has an ECOG performance status of 0-1.
Has a histologically confirmed advanced solid tumor. Subjects must have received at least 2 doses of an approved anti-PD-1/L1 mAb, and have documented progression on or within 12 weeks from the last dose of anti-PD-1/L1 mAb.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 year
Awards & highlights
Study Summary
This trial is testing a new drug, BI-1206, in combination with pembrolizumab (a current cancer drug) to treat advanced solid tumors.
Who is the study for?
Adults with advanced solid tumors who've had at least two doses of anti-PD-1/L1 therapy and disease progression within 12 weeks after the last dose. They must have measurable disease, a life expectancy over 12 weeks, good organ function, and be able to consent. Exclusions include active brain metastases, severe pneumonitis history, high steroid needs, pregnancy or breastfeeding women, recent major surgery recovery patients, high medical risk due to systemic diseases including infections or graft versus host disease.Check my eligibility
What is being tested?
The trial is testing BI-1206 in combination with Pembrolizumab for those whose tumors progressed after anti-PD-1/L1 treatment. It's a Phase 1/2a study focusing on safety and effectiveness across different cohorts based on tumor type and previous treatments.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system such as inflammation in various organs (like lungs), infusion-related reactions which can occur during drug administration; fatigue; digestive issues; blood disorders that affect cell counts; increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My advanced cancer progressed despite receiving at least 2 doses of anti-PD-1/L1 treatment.
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My organ functions are within normal ranges according to recent tests.
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I have received prior anti-PD-1/PD-L1 therapy for my cancer.
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I am 18 years old or older.
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I cannot or choose not to receive standard cancer treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determining the MTD of BI-1206 at the same dose level experiencing a BI-1206 or pembrolizumab-related or possibly related dose-limiting toxicity (DLT)
Documenting AEs and SAEs and determining causality in relation to BI-1206 IV or SC and/or pembrolizumab
Secondary outcome measures
Evaluation of ADA response to BI-1206 IV or SC
Evaluation of PK parameters for BI-1206 IV and SC.
Measurement of CD32b receptor occupancy on B cells.
Other outcome measures
Assessment of best disease responses according to Immunological Response Evaluation Criteria in Solid Tumors (iRECIST).
Evaluate BI-1206 IV or SC and pembrolizumab tumor penetrance in biopsies
Measurement of duration of objective response and objective response rate
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: BI-1206 + Pembrolizumab 25mg/mL (MK-3475)Experimental Treatment1 Intervention
BI-1206 administrated either IV or SC + Pembrolizumab 200mg administered IV every third week as a fixed dose will be used.
Find a Location
Who is running the clinical trial?
BioInvent International ABLead Sponsor
17 Previous Clinical Trials
1,647 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,581 Total Patients Enrolled
Carneiro, PhDPrincipal InvestigatorLund University Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have metastatic melanoma and have been treated with anti-PD-1 therapy, and if applicable, BRAF-targeted therapy.I need more than 10 mg of prednisolone or a similar medication daily.I can safely have a biopsy before starting BI-1206 treatment.I have AL amyloidosis affecting my heart or kidneys.I've had severe side effects from previous immune therapy.I am fully active or can carry out light work.I have chronic graft versus host disease.I have not received a live vaccine in the last 30 days.You have a condition where your immune system mistakenly attacks your own body.I am a woman who can become pregnant, am currently pregnant, or am breastfeeding.I have HIV or a history of hepatitis B or C, or tested positive for them.I haven't had chemotherapy, radiotherapy, or immunotherapy within the required washout periods before starting BI-1206.I am a man whose partner can become pregnant and I've recently had major surgery.You are allergic to pembrolizumab or BI-1206 or any of the ingredients in these drugs.I have had active tuberculosis in the past.I have serious heart problems that are not under control.I have not taken immunosuppressive drugs in the last 7 days.My advanced cancer progressed despite receiving at least 2 doses of anti-PD-1/L1 treatment.I am at high risk due to a severe infection being treated with antibiotics, antifungals, or antivirals.I haven't been in a drug study or used a study device in the last 4 weeks.I have NSCLC with specific treatment history based on my tumor's PD-L1 status or genetic changes.I have had or currently have lung inflammation treated with steroids.I have received an organ or tissue transplant from another person.My organ functions are within normal ranges according to recent tests.I have received prior anti-PD-1/PD-L1 therapy for my cancer.I have cancer that has spread to my brain or spinal cord.I am 18 years old or older.I still have side effects from cancer treatment that are not mild.I have been diagnosed with more than one type of cancer.I cannot or choose not to receive standard cancer treatments.
Research Study Groups:
This trial has the following groups:- Group 1: BI-1206 + Pembrolizumab 25mg/mL (MK-3475)
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.
Is this experiment currently open for enrollment?
"Affirmative. Clinicaltrials.gov evidences this trial's active recruitment status, which began on June 29th 2020 and was recently updated in December 2021. The researchers need 90 individuals to be enrolled across 4 sites."
Answered by AI
What are the key goals of this research endeavor?
"This 42-day experiment aims to analyse the safety and efficacy of BI-1206 in combination with pembrolizumab. Secondary objectives include examining ADA response, tracking pharmacokinetic parameters, and measuring CD32b receptor occupancy on B cells."
Answered by AI
Are there numerous healthcare facilities performing this research within the state's confines?
"Recruitment for this medical trial is taking place at a variety of locations, such as Sarah Cannon Research Institute in Denver, NEXT Oncology in San Antonio and Stephenson Cancer Center in Oklahoma City; four additional sites are also participating."
Answered by AI
Are there any additional investigations that have been undertaken on Pembrolizumab 25 MG/ML(MK-3475)?
"At the present time, 961 studies investigating Pembrolizumab 25 MG/ML(MK-3475) are taking place. Of those trials, 122 have reached Phase 3 and 35731 sites across various locations are running research for this remedy. Notably, a majority of these studies can be found in Houston, Texas."
Answered by AI
What is the population size of this research endeavor?
"Affirmative. According to the information posted online on clinicaltrials.gov, this research is actively looking for volunteers and was first published in late June 2020. As of December 2021, 90 participants are needed at 4 trial sites."
Answered by AI
In what medical situations is Pembrolizumab 25 MG/ML(MK-3475) prescribed?
"Pembrolizumab 25 MG/ML(MK-3475) is often used to treat aggressive tumors. It can also be effective at managing microsatellite instability high, unresectable melanoma and disease progression after chemotherapy."
Answered by AI
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