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

Pancreatic Cancer Clinical Trial

Official title:
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

Status Terminated

Clinical Trial 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 advanced unresectable or metastatic Claudin 18.2 (CLDN18.2)-positive solid tumors 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. Eligible tumor types are 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 can be tested for CLDN18.2 expression. 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Adenocarcinoma
Biliary Tract Cancer
Biliary Tract Neoplasms
Cholangiocarcinoma
Esophageal Adenocarcinoma
Esophageal Neoplasms
Gastric Cancer
Gastroesophageal Junction Adenocarcinoma
Metastatic Cancer
Neoplasm Metastasis
Pancreatic Cancer
Pancreatic Neoplasms
Solid Tumor
Stomach Neoplasms

Clinical Trial Details

NCT number	NCT04683939
Study type	Interventional
Source	BioNTech SE
Contact
Status	Terminated
Phase	Phase 1/Phase 2
Start date	January 18, 2022
Completion date	July 24, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05305001` - Germline Mutations Associated With Hereditary Pancreatic Cancer in Unselected Patients With Pancreatic Cancer in Mexico
Completed	`NCT02526017` - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers	Phase 1
Recruiting	`NCT05497531` - Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers	N/A
Recruiting	`NCT04927780` - Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer	Phase 3
Recruiting	`NCT06054984` - TCR-T Cells in the Treatment of Advanced Pancreatic Cancer	Early Phase 1
Recruiting	`NCT05919537` - Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation	Phase 1
Terminated	`NCT03140670` - Maintenance Rucaparib in BRCA1, BRCA2 or PALB2 Mutated Pancreatic Cancer That Has Not Progressed on Platinum-based Therapy	Phase 2
Terminated	`NCT00529113` - Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer	Phase 1
Recruiting	`NCT05168527` - The First Line Treatment of Fruquintinib Combined With Albumin Paclitaxel and Gemcitabine in Pancreatic Cancer Patients	Phase 2
Active, not recruiting	`NCT04383210` - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors	Phase 2
Recruiting	`NCT05391126` - GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care	N/A
Terminated	`NCT03300921` - A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer	Phase 1
Completed	`NCT03153410` - Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas	Early Phase 1
Recruiting	`NCT03175224` - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors	Phase 2
Recruiting	`NCT05679583` - Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer	Phase 2
Recruiting	`NCT04183478` - The Efficacy and Safety of K-001 in the Treatment of Advanced Pancreatic Cancer	Phase 2/Phase 3
Terminated	`NCT03600623` - Folfirinox or Gemcitabine-Nab Paclitaxel Followed by Stereotactic Body Radiotherapy for Locally Advanced Pancreatic Cancer	Early Phase 1
Recruiting	`NCT04584008` - Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics	N/A
Recruiting	`NCT05351983` - Patient-derived Organoids Drug Screen in Pancreatic Cancer	N/A
Completed	`NCT04290364` - Early Palliative Care in Pancreatic Cancer - a Quasi-experimental Study