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Monoclonal Antibodies

BNT141 for Esophageal 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
Metastatic or unresectable solid tumor
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights

Study Summary

This trial is designed to find the best dose of BNT141 for treating patients with CLDN18.2-positive tumors who have no other treatment options. The trial will first test BNT141 alone and then in combination with nab-paclitaxel and gemcitabine. The trial will be conducted in three parts, with the third part to be added at a later stage.

Eligible Conditions
  • Esophageal Cancer
  • Pancreatic Cancer
  • Gastroesophageal Junction Adenocarcinoma
  • Stomach Cancer
  • Cancer
  • Solid Tumors
  • Biliary Tract Cancer
  • Bile Duct Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a type of cancer that has spread to other parts of the body and cannot be completely removed by surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

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 BNT141 due to TEAEs throughout the study and up to 60 days after last subject last treatment
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 outcome measures
BNT141 - Disease control rate (DCR)
BNT141 - Duration of response (DOR)
BNT141 - Objective response rate (ORR)
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part 1B - BNT141 in combination with nab-paclitaxel and gemcitabineExperimental Treatment3 Interventions
BNT141 will be administered once every three weeks (Q3W). Nab-paclitaxel and gemcitabine will be administered on three days of each 28-day cycle.
Group II: 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
Gemcitabine
2017
Completed Phase 3
~2070
Nab-paclitaxel
2014
Completed Phase 3
~2030

Find a Location

Who is running the clinical trial?

BioNTech SELead Sponsor
63 Previous Clinical Trials
108,160 Total Patients Enrolled
BioNTech Responsible PersonStudy DirectorBioNTech SE
32 Previous Clinical Trials
8,645 Total Patients Enrolled

Media Library

BNT141 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04683939 — Phase 1 & 2
Esophageal Cancer Research Study Groups: Part 1A - BNT141 monotherapy escalation, Part 1B - BNT141 in combination with nab-paclitaxel and gemcitabine
Esophageal Cancer Clinical Trial 2023: BNT141 Highlights & Side Effects. Trial Name: NCT04683939 — Phase 1 & 2
BNT141 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04683939 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many facilities are currently administering this trial?

"There are 7 distinct medical centres participating in this clinical trial, including MD Anderson Cancer Center of Houston, START in Duarte and City of Hope in Montréal."

Answered by AI

Is it feasible to enroll new participants in this experiment?

"The findings on clinicaltrials.gov suggest that as of 11/29/2022, this experiment is still recruiting participants. It was initially posted to the database on 1/18/2022."

Answered by AI

What is the total sample size of this clinical research?

"Affirmative. Clinicaltrials.gov have the latest information, which shows that this trial began recruitment on January 18th 2022 and is still searching for participants today. 96 patients need to be enrolled from 7 different locations."

Answered by AI
~4 spots leftby Mar 2025