A Phase Ib/II, Multi-site, Open-label, Dose Finding Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of BNT326 in Combination With BNT327 in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)

BioNTech SE

Summary

This is a multi-site, open-label, dose-finding study, consisting of Parts 1, 2a, and 2b to investigate the combination of BNT326 with BNT327 in participants with relapsed, progressive as well as treatment-naïve, advanced/metastatic non-small cell lung cancer (NSCLC). This study will enroll adult participants with histologically or cytologically confirmed NSCLC that is advanced (i.e., either metastatic or recurrent tumors with no known curative treatment available).

Description

Part 1 is a dose escalation to evaluate and establish two or three safe combination dose levels (DL1 and DL2 and optionally DL3) of BNT326 with BNT327. Part 2a is a dose expansion to evaluate the preliminary efficacy, safety, and tolerability. Part 2b is a dose optimization and contribution of components part. Parts 1 and 2a (Cohort A) will enroll participants with previous exposure to therapy for advanced/metastatic disease. Part 2a (Cohort B) and Part 2b (Cohorts C and D) will enroll less heavily pre-treated participants, namely those without prior systemic treatment for advanced/metastat…

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Key Inclusion Criteria (applicable to all participants and all parts unless otherwise specified): * Aged ≥18 years at the time of giving informed consent. * Have measurable disease defined by RECIST v1.1. * All participants have to provide a tumor tissue sample (e.g. Formalin-fixed paraffin-embedded \[FFPE\] slides or block) from archival tissue. Alternatively, a fresh biopsy should be collected, unless medically not justifiable to be conducted. * Have Eastern Cooperative Oncology Group performance status of 0 or 1. * Have adequate organ and bone marrow function within 7 days before randomiza…

Interventions

Drug
BNT326
intravenous (IV) infusion
Drug
BNT327
IV infusion
Drug
Pembrolizumab
IV infusion
Drug
SoC
IV infusion. Combination chemotherapy (pemetrexed, paclitaxel, or carboplatin). Chemotherapy will be selected according to the indication.

Locations (68)

Stanford Cancer Institute
Stanford, California
Yale University
New Haven, Connecticut
Moffit Cancer Center
Tampa, Florida
Dana-Farber Cancer Institute
Boston, Massachusetts
Henry Ford Health System
Detroit, Michigan
Memorial Sloan Kettering Cancer Center
New York, New York