This is a multi-site, open-label, dose-finding study, consisting of Parts 1, 2a, and 2b to investigate the combination of BNT326 with pumitamig (also known as BNT327 or PM8002) 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). The main goals of this study are: 1. To find the best dose levels (DLs) for the combination of BNT326 and pumitamig. 2. To look at how well participants with advanced NSCLC tolerate the combination therapy (for example, which side effects participants experience and how severe they are). 3. To look at how well the combination therapy works to shrink the tumor in participants with advanced NSCLC.
Part 1 is a combination dose finding part. Participants will receive one of six combination DLs to evaluate and establish safe combination DLs of BNT326 with pumitamig, and to define the recommended Phase 2 combination dose. Part 2a is a dose expansion part to evaluate the preliminary efficacy, safety, and tolerability. Part 2b is a randomized dose optimization and contribution of components part. Parts 1, Part 2a (Cohort A) and Part 2b (Cohort C) will enroll participants with previous exposure to therapy for advanced/metastatic disease. Part 2a (Cohort B) and Part 2b (Cohort D) will enroll participants without prior systemic treatment for advanced/metastatic disease. The sponsor, having heard the internal review committee (IRC), will determine the DLs for each arm in Part 2b Cohorts C and D based on data generated from Parts 1 and 2a. The DLs chosen for Part 2b Cohorts C and D will not exceed the highest dose level investigated in this study. Parts 1 and 2a will be non-randomized. In Part 2b, participants will be randomized to different treatments within each cohort. The study consists of a screening period, a treatment period, a safety follow-up period, an efficacy follow-up period, and a long-term survival follow-up. Participants will receive study treatment until disease progression, withdrawal of consent, termination of the study by the sponsor, unacceptable toxicity, or for a maximum duration of 24 months, whichever occurs first. If a participant continues to derive clinical benefit after having reached the maximum treatment period of 24 months, continuation of study treatment will be considered on a case-by-case after discussion with the sponsor. For each study participant, the treatment and follow-up periods are projected to be completed within \~36 months, unless the participant is continuing to benefit from treatment per investigator's recommendation and upon sponsor approval.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
880
UCLA Hematology Oncology - Main Site
Los Angeles, California, United States
RECRUITINGStanford Cancer Institute
Stanford, California, United States
RECRUITINGYale University
New Haven, Connecticut, United States
RECRUITINGGeorgetown University - Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
Part 1 - Occurrence of dose limiting toxicities (DLTs) within a participant
During the DLT evaluation period by dose level
Time frame: 21 days starting on Day 1 of Cycle 1
Part 1 and Part 2a - Occurrence of treatment emergent adverse events (TEAEs), treatment-related adverse events (TRAE), treatment emergent serious adverse events (TESAE), treatment-related serious adverse events (TRSAE)
Time frame: from the first dose of investigational medicinal product (IMP) up to 90 days after the last dose of IMP or until a new systemic anti-cancer therapy is started, whichever occurs first (up to a maximum of 27 months)
Part 1 and Part 2a - Occurrence of dose interruption, reduction, and discontinuation due to TEAEs
Time frame: from the first dose of IMP up to 90 days after the last dose of IMP or until a new systemic anti-cancer therapy is started, whichever occurs first (up to a maximum of 27 months)
Part 2a and Part 2b - Objective response rate (ORR)
Defined as the percentage of participants in whom a confirmed complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\] based on the investigator's assessment) is observed as best overall response.
Time frame: from the time of initiation of the first dose of IMP to approximately 36 months
Part 1 - ORR
Defined as the percentage of participants in whom a confirmed CR or PR (per RECIST v1.1 based on the investigator's assessment) is observed as best overall response.
Time frame: from the time of initiation of the first dose of IMP to approximately 36 months
Part 2b - Occurrence of TEAEs, TRAEs, TESAEs, TRSAEs
Time frame: from the first dose of IMP up to 90 days after the last dose of IMP or until a new systemic anti-cancer therapy is started, whichever occurs first (up to a maximum of 27 months)
Part 2b - Occurrence of dose interruption, reduction, and discontinuation due to TEAEs
Time frame: from the first dose of IMP up to 90 days after the last dose of IMP or until a new systemic anti-cancer therapy is started, whichever occurs first (up to a maximum of 27 months)
Part 2a and Part 2b - Progression free survival based on the investigator's assessment
Defined as the time from first dose of IMP to the first objective tumor progression (progressive disease \[PD\] per RECIST v1.1) or death from any cause, whichever occurs first.
Time frame: from the first dose of IMP to approximately 36 months
Part 2a and Part 2b - Disease control rate
Defined as the proportion of participants with CR, PR, or stable disease (per RECIST v1.1 based on the investigator's assessment) as best overall response.
Time frame: from the first dose of IMP to approximately 36 months
Part 2a and Part 2b - Duration of response
Defined as the time from first confirmed objective response (CR or PR per RECIST v1.1 based on the investigator's assessment) to first occurrence of objective tumor progression (PD per RECIST v1.1 based on the investigator's assessment) or death from any cause, whichever occurs first
Time frame: from the first dose of IMP to approximately 36 months
Part 2a and Part 2b - Time to response
Defined as the time from first dose of IMP to first confirmed objective response (CR or PR per RECIST v1.1 based on the investigator's assessment) in participants with a confirmed objective response
Time frame: from the first dose of IMP to approximately 36 months
Part 2a and Part 2b - Overall survival
Defined as the time from first dose of IMP to death from any cause
Time frame: from the first dose of IMP to approximately 36 months
All cohorts - Pharmacokinetics (PK) assessment: Maximum concentration derived from serum concentrations of BNT326 antibody-drug conjugate (ADC), total anti-human epidermal growth factor receptor 3 (HER3) antibody component, and unconjugated payload
For applicable participants, if data permits.
Time frame: from the first IMP up to safety follow-up, approximately 90 days post last IMP dose
All cohorts - PK assessment: Time to reach maximum (peak) serum concentration derived from serum concentrations of BNT326 ADC, total anti-HER3 antibody component, and unconjugated payload
For applicable participants, if data permits.
Time frame: from the first dose of IMP up to safety follow-up, approximately 90 days post last IMP dose
All cohorts - Anti-drug antibody (ADA) prevalence and ADA incidence
By cohort and combination treatment regimen for applicable participants
Time frame: up to 1 year from the last dose of IMP
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Moffit Cancer Center
Tampa, Florida, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGHenry Ford Health System
Detroit, Michigan, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGCleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer Center
Cleveland, Ohio, United States
RECRUITINGUniversity of Texas M. D. Anderson Cancer Center
Houston, Texas, United States
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