This study is the first time the drug BNT3214 (also referred to as PM8102) will be tested in people. It is designed to find out if the drug is safe and how well it works for adults with advanced solid tumors. The study will have three parts. The first two parts (Parts A and B) will focus on testing different amounts of BNT3214 to figure out the best and safest dose. The third part (Part C) will test selected doses of BNT3214 in multiple types of cancer.
Participants aged ≥18 years of age inclusive at the time of giving informed consent.
Have at least one measurable tumor lesion based on RECIST v1.1. One lesion with prior local treatment (i.e., radiotherapy) can be considered measurable only if a disease progression from prior local treatment was demonstrated in the lesion per RECIST v1.1.
Eastern Cooperative Oncology Group performance status of 0 or 1.
Have a predicted life expectancy ≥3 months.
Untreated or symptomatic central nervous system (CNS) metastases and leptomeningeal disease.
Have a primary CNS malignancy.
Have active, or a history of, pneumonitis requiring treatment with steroids, or have active, or a history of, interstitial lung disease.
Have clinically significant pulmonary complications including, but not limited to, chronic obstructive pulmonary disease, restrictive lung disease, lung injury accompanied with autoimmune disease/connective tissue disorders.
Sequential
BNT3214
DrugIntravenous infusion
All parts - Number and percentage of participants with treatment emergent adverse events (TEAEs)
Per DL/cohort. By United States National Cancer Institute Common Terminology Criteria for Adverse Events grading, seriousness, and relatedness.
All parts - Number and percentage of participants with dose interruptions, reductions, and discontinuation of BNT3214 due to TEAEs
Per DL/cohort.
Parts A and B only - Number and percentage of participants with dose limiting toxicities (DLTs)
During the DLT evaluation period
Part C only - Objective response rate (ORR)
Per DL/cohort. Defined as the percentage of participants in whom a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 (based on the investigator's assessment) is observed as best overall response.
All parts - PK assessment: Area under the curve (AUC)
Per DL/cohort. Derived for BNT3214 levels in plasma or serum (for Cycle 1, single-dose and Cycle 3, multiple-dose). If data permits.
All parts - PK assessment: Maximum concentration (Cmax)
Per DL/cohort. Derived for BNT3214 levels in plasma or serum (for Cycle 1, single-dose and Cycle 3, multiple-dose). If data permits.
All parts - PK assessment: Time to maximum observed concentration (Tmax)
Per DL/cohort. Derived for BNT3214 levels in plasma or serum (for Cycle 1, single-dose and Cycle 3, multiple-dose). If data permits.
All parts - PK assessment: Half-life (t1/2)
Per DL/cohort. Derived for BNT3214 levels in plasma or serum (for Cycle 1, single-dose and Cycle 3, multiple-dose). If data permits.
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BioNTech SE
Lead sponsor
BioNTech (Shanghai) Pharmaceuticals Co., Ltd.
Collaborator
Biotheus (Hengqin) Co., Ltd.
Collaborator
