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 Terminated 13 enrolled BioNTech SE

Non-randomizedSequentialOpen-labelTreatment

Summary

This study was planned as an open-label, multi-site, Phase I/IIa dose escalation, safety, and pharmacokinetic (PK) trial of BNT141 followed by expansion cohorts in patients with Claudin 18.2 (CLDN18.2)-positive tumors. The sponsor decided to stop the development of BNT141 on 24 July 2023 and the study was terminated early.

Timeline

Start: 2022-01-18
Primary completion: 2023-07-24
Completion: 2023-07-24

Outcome

Outcome not reported

Stopped (Business): “Sponsor decision”

Publications

Bahr-Mahmud H, Ellinghaus U, Stadler CR, Fischer L, Lindemann C, Chaturvedi A, Diekmann J, Woll S, Biermann I, Hebich B, Scharf C, Siefke M, Roth AS, Rao M, Brettschneider K, Ewen EM, Sahin U, Tureci O. Preclinical characterization of an mRNA-encoded anti-Claudin 18.2 antibody. Oncoimmunology. 2023 Oct 16;12(1):2255041. doi: 10.1080/2162402X.2023.2255041. eCollection 2023.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BNT141	Messenger RNA (mRNA)	0.15 mg/kg	Intravenous
Subject	BNT141	Messenger RNA (mRNA)	0.3 mg/kg	Intravenous
Subject	BNT141	Messenger RNA (mRNA)	0.45 mg/kg	Intravenous
Subject	BNT141	Messenger RNA (mRNA)	0.6 mg/kg	Intravenous
Background	Gemcitabine	Small molecule	—	—
Background	Nab-paclitaxel	Small molecule	—	—