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Monoclonal Antibodies
BNT141 for Stomach Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by BioNTech SE
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of bnt141 treatment until the second safety follow-up visit (60 ± 7 days after last dose), up to 30 weeks.
Awards & highlights
No Placebo-Only Group
Summary
This trial tests BNT141, a new drug for treating advanced cancers with high levels of the Claudin 18.2 protein. It targets patients whose cancers do not respond to standard treatments. The drug works by attacking cancer cells with this specific protein, aiming to stop their growth.
Eligible Conditions
- Stomach Cancer
- Bile Duct Cancer
- Biliary Tract Cancer
- Solid Tumors
- Gastroesophageal Junction Adenocarcinoma
- Esophageal Cancer
- Pancreatic Cancer
- Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of bnt141 treatment until the second safety follow-up visit (60 ± 7 days after last dose), up to 30 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of bnt141 treatment until the second safety follow-up visit (60 ± 7 days after last dose), up to 30 weeks.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Occurrence of Dose Reductions and Discontinuation of BNT141 Due to TEAEs
Occurrence of Dose-limiting Toxicities (DLTs) Within a Patient During the DLT Evaluation Period
Occurrence of Treatment-emergent Adverse Events (TEAEs) Within a Patient Including Grade ≥ 3, Serious, Fatal TEAE by Relationship
Secondary study objectives
Disease Control Rate (DCR)
Duration of Response (DoR)
Objective Response Rate (ORR)
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Part 2 - predefined expansion cohortsExperimental Treatment3 Interventions
BNT141 in combination with nab-paclitaxel and gemcitabine
Group II: Part 1B - BNT141 in combination with nab-paclitaxel and gemcitabineExperimental Treatment3 Interventions
BNT141 was planned to be administered Q3W. Nab-paclitaxel and gemcitabine was planned to be administered on three days of each 28-day cycle.
Group III: Part 1A - BNT141 monotherapy escalationExperimental Treatment1 Intervention
Administration once every three weeks (Q3W)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nab-paclitaxel
2014
Completed Phase 3
~1950
Gemcitabine
2017
Completed Phase 3
~1920
Find a Location
Who is running the clinical trial?
BioNTech SELead Sponsor
71 Previous Clinical Trials
111,146 Total Patients Enrolled
BioNTech Responsible PersonStudy DirectorBioNTech SE
36 Previous Clinical Trials
9,975 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a type of cancer that has spread to other parts of the body and cannot be completely removed by surgery.You have received treatment with a certain type of medication that targets CLDN18.2, except for a specific one called BNT141.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2 - predefined expansion cohorts
- Group 2: Part 1A - BNT141 monotherapy escalation
- Group 3: Part 1B - BNT141 in combination with nab-paclitaxel and gemcitabine
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.
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