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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histological or cytological documentation of a solid tumor that is metastatic or unresectable via a pathology report.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose until 60 days after last dose
Awards & highlights
Study Summary
This trial is testing a new drug, BNT142, for safety and how well it works in patients with tumors that have a protein called Claudin 6.
Who is the study for?
This trial is for adults with solid tumors that are CLDN6-positive, metastatic or cannot be surgically removed. They must have tried all standard treatments without success and not received certain therapies within specific time frames before the trial. Pregnant or breastfeeding individuals, those with new brain metastases, or on high-dose steroids are excluded.Check my eligibility
What is being tested?
The clinical trial is testing BNT142 in patients with advanced CLDN6-positive tumors. It's an early-phase study to determine safe dosage levels and initial effectiveness while monitoring how the body processes the drug across multiple centers.See study design
What are the potential side effects?
While specific side effects of BNT142 aren't listed here, common ones from similar trials may include fatigue, nausea, immune-related reactions, infusion site discomfort, and potential impacts on blood counts leading to increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has spread or cannot be removed by surgery, confirmed by a pathology report.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose to 60 days after the last dose of bnt142
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose to 60 days after the last dose of bnt142
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 reductions and discontinuation of BNT142 due to TEAEs
Occurrence of treatment emergent adverse events (TEAEs) including Grade ≥3, serious, or fatal TEAEs by causal relationship to study treatment
Part 1: Occurrence of dose-limiting toxicities (DLTs) during the DLT evaluation period (Cycle 1, i.e., 21 days after the first dose) during the dose escalation
+1 moreSecondary outcome measures
Disease control rate (DCR)
Duration of response (DOR)
Part 1: ORR
+8 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: BNT142Experimental Treatment1 Intervention
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Who is running the clinical trial?
BioNTech SELead Sponsor
64 Previous Clinical Trials
107,368 Total Patients Enrolled
BioNTech Responsible PersonStudy DirectorBioNTech SE
33 Previous Clinical Trials
9,454 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major surgery in the last 4 weeks.My tumor is CLDN6 positive based on a specific tissue test.I am not pregnant, breastfeeding, nor planning to become pregnant soon.My cancer has spread or cannot be removed by surgery, confirmed by a pathology report.I have advanced cancer and standard treatments haven't worked or aren't suitable for me.I haven't had cancer treatments like radiotherapy or chemotherapy in the last 3 weeks or more.I am taking more than 10 mg of prednisone daily for a condition other than hormone replacement.I haven't had IV anti-infective therapy in the last 2 weeks.I have mostly recovered from side effects of previous treatments, except for minor issues like hair loss.My brain metastases are stable, and I'm not on acute steroids.I have been treated with a CLDN6 targeting antibody before.
Research Study Groups:
This trial has the following groups:- Group 1: BNT142
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.
In what locations can this research be accessed?
"Currently, patients can choose from 5 recruitment sites to participate in this trial. These include Cedars-Sinai Medical Center (Los Angeles), South Texas Accelerated Research Therapeutics (START) - San Antonio, and University of Pennsylvania (Philadelphia)."
Answered by AI
Is the enrollment process for this clinical trial open at present?
"Data hosted on clinicaltrials.gov attests to the fact that this medical experiment is presently recruiting subjects. This project was initially submitted on March 28th 2022, and its information has since been updated on September 30th 2022."
Answered by AI
How extensive is the participant base for this research endeavor?
"This clinical trial requires 216 individuals that meet the specified qualifications. Potential participants can be found in Cedars-Sinai Medical Center of Los Angeles, California and South Texas Accelerated Research Therapeutics (START) - San Antonio located in Pennsylvania."
Answered by AI
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