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

Who is this study for? Patients with Solid Tumor
What treatments are being studied? BNT141
Status: Terminated
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ For all Parts:

• Metastatic or unresectable solid tumor.

• Histological or cytological documentation of a solid tumor via a pathology report.

• CLDN18.2-positive tumor sample defined as moderate-to-strong CLDN18.2 protein expression defined as intermediate (2+) to strong (3+) staining intensity in ≥ 50% of tumor cells as assessed by central testing using a CLIA-validated immunohistochemistry assay in formalin-fixed, paraffin-embedded (FFPE) neoplastic tissues. New biopsies and archival bio-samples are allowed. Bone biopsies are not allowed. Cytology specimens (including fine needle aspirates) will not be accepted for CLDN18.2 examination. If archival tissue samples from several points of time are available, the most recent one is preferred. Patients with a lower expression level or with CLDN18.2-negative cancers are not eligible.

⁃ Trial part-specific inclusion criteria:

⁃ For Part 1A: Patients with 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. Patients must have received all available standard therapies and failed at least first-line standard of care therapy prior to enrolment. Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Eligible tumor types are gastric cancer, 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.

⁃ For Part 1B: Patients with advanced pancreatic adenocarcinoma or cholangiocarcinoma who are eligible for treatment with nab-paclitaxel and gemcitabine. Measurable or evaluable disease per RECIST 1.1.

Locations
United States
California
City of Hope
Duarte
Texas
MD Anderson Cancer Center
Houston
NEXT Oncology
San Antonio
START
San Antonio
Other Locations
Canada
University of Montreal - Centre Hospitalier de l´Université de Montréal
Montreal
Princess Margaret Cancer Centre - University Health Network
Toronto
St. Michaels Hospital
Toronto
Time Frame
Start Date: 2022-01-18
Completion Date: 2023-07-24
Participants
Target number of participants: 13
Treatments
Experimental: Part 1A - BNT141 monotherapy escalation
Administration once every three weeks (Q3W)
Experimental: Part 1B - BNT141 in combination with nab-paclitaxel and gemcitabine
BNT141 was planned to be administered Q3W. Nab-paclitaxel and gemcitabine was planned to be administered on three days of each 28-day cycle.
Experimental: Part 2 - predefined expansion cohorts
BNT141 in combination with nab-paclitaxel and gemcitabine
Sponsors
Leads: BioNTech SE

This content was sourced from clinicaltrials.gov

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