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Monoclonal Antibodies

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

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

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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of bnt141 treatment until the second safety follow-up visit (60 ± 7 days after last dose), up to 30 weeks. for reporting.

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 more

Awards & 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
77 Previous Clinical Trials
115,809 Total Patients Enrolled
BioNTech Responsible PersonStudy DirectorBioNTech SE
38 Previous Clinical Trials
11,435 Total Patients Enrolled

Media Library

BNT141 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04683939 — Phase 1 & 2
Cholangiocarcinoma Research Study Groups: Part 2 - predefined expansion cohorts, Part 1A - BNT141 monotherapy escalation, Part 1B - BNT141 in combination with nab-paclitaxel and gemcitabine
Cholangiocarcinoma 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
~3 spots leftby Dec 2025
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