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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate hematologic function at screening as determined by: White blood cell count (WBC) ≥ 3 × 10^9/L, Absolute neutrophil count ≥ 1.5 × 10^9/L (patient may not use granulocyte-colony stimulating factor (G-CSF) or granulocyte-macrophage colony stimulating factor (GM-CSF) to achieve these WBC and absolute neutrophil count levels), Platelet count ≥ 100 × 10^9/L, Hemoglobin (Hgb) ≥ 9.0 g/dL.
Adequate hepatic function at screening as determined by: Total bilirubin ≤ 1.5 mg/dL (or ≤ 2.0 mg/dL for patients with known Gilbert's syndrome or liver metastasis), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; ≤ 3 × ULN for patients with liver metastasis.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Study Summary
This trial is designed to test the safety and effectiveness of BNT152+153 in patients with various solid tumors. The trial will enroll patients who have no available standard therapy or are not candidates for such therapy. The trial will have two parts with adaptive design elements. Part 1 will test dose escalation for BNT153 and BNT152. Part 2 will start after the MTD/MAD have been established for BNT153 and OBD for BNT152. The trial will also implement biomarker expansion cohorts after BNT153 and/or BNT152 dose escalation is completed.
Who is the study for?
Adults with advanced solid tumors that can't be surgically removed or have spread, and who've run out of standard treatment options. They must have a certain level of blood clotting ability, organ function, and agree to use effective birth control. Those with brain metastases may qualify if stable and not requiring steroids.Check my eligibility
What is being tested?
The trial is testing BNT152+153 in patients with various solid tumors. It's an early-phase study to determine safe dosage levels (Part 1) and then find the best dose for future studies (Part 2). Patients will receive either BNT152 or BNT153 alone first, followed by a combination of both.See study design
What are the potential side effects?
Specific side effects are not listed but may include typical reactions to cancer drugs such as nausea, fatigue, risk of infection due to low blood counts, liver issues indicated by abnormal tests results, allergic reactions or other immune-related effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood tests meet the required levels for white blood cells, neutrophils, platelets, and hemoglobin.
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My liver is functioning well according to recent tests.
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My kidneys are functioning well enough for the trial.
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My cancer is advanced, cannot be surgically removed, and standard treatments are not suitable or effective for me.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 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 DLTs during the DLT evaluation period - BNT153
Occurrence of dose limiting toxicities (DLTs) during the DLT evaluation period - BNT152
Occurrence of dose reduction and discontinuation of investigational medicinal product (IMP) within a patient due to TEAE
+1 moreSecondary outcome measures
Disease control rate (DCR)
Duration of response (DOR)
Objective response rate (ORR)
Trial Design
6Treatment groups
Experimental Treatment
Group I: Part 2C - BNT152+153Experimental Treatment2 Interventions
Escalating dose levels up to RP2D
Group II: Part 2B - BNT152+153Experimental Treatment2 Interventions
Escalating dose levels up to RP2D
Group III: Part 2A - BNT152+153Experimental Treatment2 Interventions
Escalating dose levels up to RP2D
Group IV: Part 2 - BNT152+153 - biomarker cohortExperimental Treatment2 Interventions
Group V: Part 1 group B BNT152Experimental Treatment1 Intervention
Monotherapy dose escalation.
Group VI: Part 1 group A BNT153Experimental Treatment1 Intervention
Monotherapy dose escalation.
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Who is running the clinical trial?
BioNTech SELead Sponsor
64 Previous Clinical Trials
107,528 Total Patients Enrolled
BioNTech Responsible PersonStudy DirectorBioNTech SE
33 Previous Clinical Trials
9,614 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your white blood cell count needs to be at least 3 billion cells per liter.You are allergic to any part of the treatment being used in the trial.You have enough platelets in your blood, with a count of at least 100 billion per liter.My blood tests meet the required levels for white blood cells, neutrophils, platelets, and hemoglobin.My kidneys are functioning well enough for the trial.My brain metastases are stable, and I'm not on acute steroids.I am HIV positive with a CD4+ count below 350 and have had AIDS-related infections.I have not had major surgery in the last 4 weeks.I agree to have at least two biopsies from my tumor for the study.I am taking more than 10 mg of prednisone or a similar steroid daily for another health issue.My liver is functioning well according to recent tests.I have not had a stroke or mini-stroke in the last 6 months.Your blood clotting test results should be normal, unless you are taking medication to thin your blood and your test results are within the expected range.I haven't used any experimental drugs or devices in the last 28 days.I haven't had an IV infection treatment in the last 2 weeks.I need drainage for fluid build-up in my chest or abdomen.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 have had cancer before, but it has been in remission for at least 2 years or was a type with low risk of spreading.My blood clotting time is within the normal range, or I am on blood thinners with levels in the therapeutic range.You have a disease that can be measured or evaluated using a specific medical guideline called RECIST1.1.My white blood cell count is healthy without using specific medications.My side effects from previous treatments are mild, except for possible nerve pain and hair loss.I agree to use effective birth control and not donate sperm during and 6 months after the trial.I haven't had cancer treatments like chemotherapy or immunotherapy close to starting this trial.My cancer is advanced, cannot be surgically removed, and standard treatments are not suitable or effective for me.I do not have an active immune disorder or need immunosuppressants, except for minor conditions.I am unable to give consent for medical procedures.I am fully active or can carry out light work.I have hepatitis B but am under treatment or have a low viral load.I don't have active hepatitis C or I've successfully completed treatment for it.I am 18 years old or older.You must read and sign a form that explains what the trial involves and agree to participate before any tests or procedures are done.I have an autoimmune disease like lupus or MS, but not well-controlled type 1 diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2C - BNT152+153
- Group 2: Part 2A - BNT152+153
- Group 3: Part 2B - BNT152+153
- Group 4: Part 2 - BNT152+153 - biomarker cohort
- Group 5: Part 1 group A BNT153
- Group 6: Part 1 group B BNT152
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.
Are there any openings in this trial for individuals to participate right now?
"As per clinicaltrials.gov, this medical trial has been open to participants since June 8th 2021 and the latest update was on November 22nd 2022."
Answered by AI
Is BNT153 usage associated with any possible adverse effects?
"The safety of BNT153 is rated as a 1 on our assessment scale due to the limited information available in Phase 1 trials. This implies that there is only minimal data demonstrating its efficacy and security."
Answered by AI
What is the uppermost limit of participants in this experiment?
"This clinical trial necessitates 112 candidates that meet the requirements to take part. Participants can join from several sites such as Sarah Cannon Research Institute at Tennessee Oncology in Nashville, and NEXT Oncology in San Antonio, Texas."
Answered by AI
What is the ultimate objective of this scientific experiment?
"The primary goal of this study is to measure the incidence of DLTs during a 24 month evaluation period. Secondary objectives include assessing patient Duration of Response, Disease Control Rate and Objective Response Rate."
Answered by AI
In what areas is this clinical experiment accessible?
"Currently, there are 6 clinics that are running this clinical trial. Participants have the option of selecting a clinic in Nashville, San Antonio and New Haven or any one of the other 3 locations to ease travel-related burdens."
Answered by AI
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