Clinical trialPhase 1 / Phase 2Terminated

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 I/IIa, First-in-human, Open-label, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BNT141 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With CLDN18.2-positive Solid Tumors

NCT04683939 ↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome: Stopped earlySponsor decision (Business decision)
Phase: Phase 1 / Phase 2
Status: Terminated
Study type: Interventional
Start: 18 January 2022
Expected end: 24 July 2023
Enrollment: 13 participants
Sites: 7
Primary outcomes: Occurrence of Treatment-emergent Adverse Events (TEAEs) Within a Patient Including Grade ≥ 3, Serious, Fatal TEAE by Relationship; 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
Sponsor: Industry
Results posted: 2024-10-02
Last update: 2 October 2024

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Brief summary public domain (ClinicalTrials.gov)

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.

Detailed description public domain (ClinicalTrials.gov)

The study design consisted of three parts: * Part 1A was a dose escalation of BNT141 as monotherapy in patients with advanced unresectable or metastatic CLDN18.2-positive solid tumors for which there was no available standard therapy considered to confer clinical benefit, or the patient was not a candidate for such available therapy. The dose of BNT141 was planned to be escalated until the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of BNT141 as monotherapy was defined. However, due to the early study termination, the dose of BNT141 was not fully escalated as planned per protocol (i.e., only four doses were tested, i.e., 0.15 mg/kg, 0.30 mg/kg, 0.45 mg/kg, and 0.60 mg/kg). Once the MTD was reached, up to 10 additional patients with CLDN18.2 expressing pancreatic and biliary tract cancers were planned to be enrolled at the MTD level to obtain additional data on safety, PK and pharmacodynamics (PD). Eligible tumor types were gastric cancer, gastroesophageal junction (GEJ) and esophageal adenocarcinoma, pancreatic, biliary tract (cholangiocarcinoma and gallbladder cancer), and mucinous ovarian cancers. Additionally, patients with specific tumors (including colorectal cancer, non-small-cell lung cancer, gastric subtype of endocervical adenocarcinoma) where there is scientific evidence that the CLDN18.2 could be elevated could be tested for CLDN18.2 expression. * Part 1B was planned to be a dose escalation of BNT141 in combination with nab-paclitaxel and gemcitabine in patients with locally advanced unresectable or metastatic CLDN18.2-positive pancreatic adenocarcinoma or cholangiocarcinoma who were eligible for treatment with nab-paclitaxel and gemcitabine. Part 1B intended to define the MTD and/or RP2D of the combination. Once the MTD was reached, up to 10 additional patients with CLDN18.2-expressing pancreatic adenocarcinoma or cholangiocarcinoma were planned to be enrolled at the MTD level to obtain additional data on safety, PK and PD. The MTD of BNT141 in combination with nab-paclitaxel and gemcitabine in Part 1B was planned to not exceed the monotherapy BNT141 MTD determined in Part 1A. * Part 2 (Expansion) was planned to consist of two predefined expansion cohorts in patients with CLDN18.2-positive solid tumors eligible for treatment with nab-paclitaxel and gemcitabine. Part 1B and Part 2 did not proceed and no participant was enrolled in Part 1B and Part 2.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Occurrence of Treatment-emergent Adverse Events (TEAEs) Within a Patient Including Grade ≥ 3, Serious, Fatal TEAE by Relationship [From start of BNT141 treatment until the second Safety Follow-up Visit (60 ± 7 days after last dose), up to 30 weeks.]. Number, participants. Any TEAE: BNT141 Monotherapy - 0.15 mg/kg (n=3): 3; BNT141 Monotherapy - 0.30 mg/kg (n=3): 3; BNT141 Monotherapy - 0.45 mg/kg (n=4): 4; BNT141 Monotherapy - 0.60 mg/kg (n=3): 3. Related TEAE: BNT141 Monotherapy - 0.15 mg/kg (n=3): 3; BNT141 Monotherapy - 0.30 mg/kg (n=3): 3; BNT141 Monotherapy - 0.45 mg/kg (n=4): 4; BNT141 Monotherapy - 0.60 mg/kg (n=3): 3. Grade ≥3 TEAE: BNT141 Monotherapy - 0.15 mg/kg (n=3): 0; BNT141 Monotherapy - 0.30 mg/kg (n=3): 2; BNT141 Monotherapy - 0.45 mg/kg (n=4): 2; BNT141 Monotherapy - 0.60 mg/kg (n=3): 1. Related Grade ≥3 TEAE: BNT141 Monotherapy - 0.15 mg/kg (n=3): 0; BNT141 Monotherapy - 0.30 mg/kg (n=3): 0; BNT141 Monotherapy - 0.45 mg/kg (n=4): 0; BNT141 Monotherapy - 0.60 mg/kg (n=3): 1. Any serious TEAE: BNT141 Monotherapy - 0.15 mg/kg (n=3): 1; BNT141 Monotherapy - 0.30 mg/kg (n=3): 1; BNT141 Monotherapy - 0.45 mg/kg (n=4): 1; BNT141 Monotherapy - 0.60 mg/kg (n=3): 2. Related serious TEAE: BNT141 Monotherapy - 0.15 mg/kg (n=3): 0; BNT141 Monotherapy - 0.30 mg/kg (n=3): 1; BNT141 Monotherapy - 0.45 mg/kg (n=4): 0; BNT141 Monotherapy - 0.60 mg/kg (n=3): 1. TEAE of special interest: BNT141 Monotherapy - 0.15 mg/kg (n=3): 0; BNT141 Monotherapy - 0.30 mg/kg (n=3): 1; BNT141 Monotherapy - 0.45 mg/kg (n=4): 0; BNT141 Monotherapy - 0.60 mg/kg (n=3): 0. TEAE leading to death: BNT141 Monotherapy - 0.15 mg/kg (n=3): 0; BNT141 Monotherapy - 0.30 mg/kg (n=3): 0; BNT141 Monotherapy - 0.45 mg/kg (n=4): 0; BNT141 Monotherapy - 0.60 mg/kg (n=3): 0.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Occurrence of Dose Reductions and Discontinuation of BNT141 Due to TEAEs [From start of BNT141 treatment until the second Safety Follow-up Visit (60 ± 7 days after last dose), up to 30 weeks.]. Number, participants. TEAE leading to treatment discontinuation: BNT141 Monotherapy - 0.15 mg/kg (n=3): 0; BNT141 Monotherapy - 0.30 mg/kg (n=3): 0; BNT141 Monotherapy - 0.45 mg/kg (n=4): 0; BNT141 Monotherapy - 0.60 mg/kg (n=3): 0. Related TEAE leading to treatment discontinuation: BNT141 Monotherapy - 0.15 mg/kg (n=3): 0; BNT141 Monotherapy - 0.30 mg/kg (n=3): 0; BNT141 Monotherapy - 0.45 mg/kg (n=4): 0; BNT141 Monotherapy - 0.60 mg/kg (n=3): 0. TEAE leading to study drug interruption: BNT141 Monotherapy - 0.15 mg/kg (n=3): 0; BNT141 Monotherapy - 0.30 mg/kg (n=3): 2; BNT141 Monotherapy - 0.45 mg/kg (n=4): 1; BNT141 Monotherapy - 0.60 mg/kg (n=3): 1. Related TEAE leading to study drug interruption: BNT141 Monotherapy - 0.15 mg/kg (n=3): 0; BNT141 Monotherapy - 0.30 mg/kg (n=3): 2; BNT141 Monotherapy - 0.45 mg/kg (n=4): 0; BNT141 Monotherapy - 0.60 mg/kg (n=3): 1. TEAE leading to dose reduction: BNT141 Monotherapy - 0.15 mg/kg (n=3): 0; BNT141 Monotherapy - 0.30 mg/kg (n=3): 0; BNT141 Monotherapy - 0.45 mg/kg (n=4): 0; BNT141 Monotherapy - 0.60 mg/kg (n=3): 0. Related TEAE leading to dose reduction: BNT141 Monotherapy - 0.15 mg/kg (n=3): 0; BNT141 Monotherapy - 0.30 mg/kg (n=3): 0; BNT141 Monotherapy - 0.45 mg/kg (n=4): 0; BNT141 Monotherapy - 0.60 mg/kg (n=3): 0. TEAE leading to dose rate reduction: BNT141 Monotherapy - 0.15 mg/kg (n=3): 0; BNT141 Monotherapy - 0.30 mg/kg (n=3): 0; BNT141 Monotherapy - 0.45 mg/kg (n=4): 0; BNT141 Monotherapy - 0.60 mg/kg (n=3): 0. Related TEAE leading to dose rate reduction: BNT141 Monotherapy - 0.15 mg/kg (n=3): 0; BNT141 Monotherapy - 0.30 mg/kg (n=3): 0; BNT141 Monotherapy - 0.45 mg/kg (n=4): 0; BNT141 Monotherapy - 0.60 mg/kg (n=3): 0.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Occurrence of Dose-limiting Toxicities (DLTs) Within a Patient During the DLT Evaluation Period [First treatment cycle (From first dose up to 21 days after first dose)]. Number, participants. BNT141 Monotherapy - 0.15 mg/kg (n=3): 0; BNT141 Monotherapy - 0.30 mg/kg (n=3): 0; BNT141 Monotherapy - 0.45 mg/kg (n=4): 0; BNT141 Monotherapy - 0.60 mg/kg (n=3): 0.