Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141
Status:
Recruiting
Trial end date:
2024-09-01
Target enrollment:
Participant gender:
Summary
This trial is an open-label, multi-site, Phase I/IIa dose escalation, safety, and
pharmacokinetic (PK) trial of BNT141 followed by expansion cohorts in patients with
CLDN18.2-positive tumors.
The trial design consists of three parts:
Part 1A is a dose escalation of BNT141 as monotherapy in patients with unresectable or
metastatic Claudin 18.2 (CLDN18.2)-positive gastric cancer, gastroesophageal junction (GEJ)
and esophageal cancer of the adenocarcinoma subtype, colorectal cancer, pancreatic cancer,
biliary tract cancers, and mucinous ovarian cancer, for which there is no available standard
therapy likely to confer clinical benefit, or the patient is not a candidate for such
available therapy. The dose of BNT141 will be escalated until the maximum tolerated dose
(MTD) and/or recommended phase II dose (RP2D) of BNT141 as monotherapy are defined.
Part 1B is a dose escalation of BNT141 in combination with nab-paclitaxel and gemcitabine in
patients with advanced unresectable or metastatic CLDN18.2-positive pancreatic adenocarcinoma
or cholangiocarcinoma who are eligible for treatment with nab-paclitaxel and gemcitabine.
Part 1B intends to define the MTD and/or RP2D of the combination.
Part 2 with adaptive design elements will be added at a later stage.