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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed solid tumor that is metastatic or of advanced unresectable stage and for whom there is no available standard therapy likely to confer clinical benefit, or patient who is not a candidate for such available therapy. If there is no contraindication, patients should have exhausted all SoC therapies before entering the trial, if possible
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 6 months
Awards & highlights
Study Summary
This trial is designed to study the safety and effectiveness of an experimental drug, BNT151, for treating various solid tumors. The trial will enroll patients who have no other available treatment options and who have either metastatic or advanced unresectable stage tumors. The trial will have three parts, with the first part being a dose escalation phase to study safety and the second and third parts being expansion cohorts to study effectiveness.
Who is the study for?
Adults with advanced solid tumors that can't be surgically removed and have no other effective standard treatments available. Participants must be over 18, not pregnant or breastfeeding, willing to use contraception, and able to provide biopsies if in the US. They should have a good performance status (able to carry out daily activities) and adequate organ function.Check my eligibility
What is being tested?
BNT151 is being tested both alone and combined with standard cancer treatments in patients with various solid tumors. The trial has three parts: dose escalation for BNT151 alone, dose escalation for BNT151 plus standard care, and an expansion phase at the best dose found.See study design
What are the potential side effects?
Specific side effects of BNT151 are not listed but may include typical reactions seen with cancer therapies such as fatigue, nausea, inflammation at injection sites, allergic reactions or changes in blood counts leading to increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced, cannot be surgically removed, and standard treatments are not likely to help.
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I can carry out all my daily activities without help.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Occurrence of dose limiting toxicities (DLTs) within a patient during the DLT evaluation period in Part 1.
Occurrence of dose reduction and discontinuation of investigational medicinal product (IMP) within a patient due to TEAE.
Occurrence of treatment emergent adverse event (TEAE) within a patient including Grade ≥3, serious, fatal TEAE by relationship.
Secondary outcome measures
Disease control rate (DCR) is defined as the proportion of patients in whom a CR or PR or stable disease (SD) (per RECIST 1.1, SD assessed at least 6 weeks after first dose) is observed as best overall response.
Duration of response (DOR) is defined as the time from first objective response (CR or PR per RECIST 1.1) to first occurrence of objective tumor progression (Progressive disease (PD) per RECIST 1.1) or death from any cause, whichever occurs first.
Objective response rate (ORR) is defined as the proportion of patients in whom a complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors [RECIST 1.1]) is observed as best overall response.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Part 1: BNT151Experimental Treatment1 Intervention
Monotherapy dose escalation in patients with advanced solid malignancies until the maximum tolerated dose (MTD) and/or RP2D
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Who is running the clinical trial?
BioNTech SELead Sponsor
64 Previous Clinical Trials
109,097 Total Patients Enrolled
BioNTech Responsible PersonStudy DirectorBioNTech SE
33 Previous Clinical Trials
9,672 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an active hepatitis C infection or have been cured of it with undetectable viral levels.I have no health issues that prevent me from taking combination cancer therapies.I am a man who will use birth control and not donate sperm during and 6 months after the trial.I have not had major surgery in the last 4 weeks.I have or had an autoimmune disease but don't need strong immune system drugs now, except for minor conditions.I agree to have at least one biopsy before treatment and, if possible, during treatment.My liver is functioning well.I can and will attend all required trial visits.I am a woman who can have children and have a negative pregnancy test, or I cannot have children due to menopause or sterilization.I am taking more than 10 mg of prednisone or its equivalent daily for another health issue.My side effects from previous treatments are mild or gone.I am HIV positive with a low CD4 count and have had AIDS-related infections.My kidney function meets the study's requirements.I haven't had IV anti-infective therapy in the last 2 weeks.I haven't had certain cancer treatments or live vaccines recently.I have brain metastases but have been treated, show no major symptoms, and am not on acute steroids.I had a stroke or mini-stroke in the last 6 months.I have hepatitis B but am under treatment or have a low viral load.I need drainage for fluid build-up in my chest or abdomen.I have had another cancer, but it has been in remission for at least 2 years or was a type with low risk of spreading.My cancer is advanced, cannot be surgically removed, and standard treatments are not likely to help.I can carry out all my daily activities without help.I agree to use effective birth control during and 6 months after the trial.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1: BNT151
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.
How many participants has this clinical research enrolled?
"Affirmative, clinicaltrials.gov records confirm that this experiment is currently recruiting participants. It was initially launched on January 26th 2021 and the latest update was November 11th 2022. 84 patients need to be recruited from 4 distinct sites."
Answered by AI
Are there any open enrollment opportunities for this research project?
"Affirmative, the details listed on clinicaltrials.gov validate that this research is currently looking for participants. The trial was initially made available to the public on January 26th 2021 and has been updated as recent as November 11th 2022. A total of 84 patients are sought from 4 different medical hubs."
Answered by AI
How many participating healthcare facilities are currently involved in this experiment?
"This study is recruiting in 4 locations which include NEXT Oncology (San Antonio), University of Texas MD Anderson Cancer Center (Houston), Sarah Cannon Research Institute at Tennessee Oncology (Nashville). Additionally, there are four further sites that are enrolling patients."
Answered by AI
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