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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 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

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 ~ up to 36 months

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

BioNTech SELead Sponsor

64 Previous Clinical Trials

109,168 Total Patients Enrolled

BioNTech Responsible PersonStudy DirectorBioNTech SE

33 Previous Clinical Trials

9,743 Total Patients Enrolled

Media Library

BNT141 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04683939 — Phase 1 & 2

Stomach Cancer Research Study Groups: Part 1A - BNT141 monotherapy escalation, Part 1B - BNT141 in combination with nab-paclitaxel and gemcitabine

Stomach 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

Recent research and studies

clinicaltrials.govStudy

Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141 in Patients With Unresectable or Metastatic CLDN18.2-positive Gastric, Pancreatic, Ovarian and Biliary Tract Tumors

2022. "Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141 in Patients With Unresectable or Metastatic CLDN18.2-positive Gastric, Pancreatic, Ovarian and Biliary Tract Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04683939.