Early-phase Trial to Assess the Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors

ConditionAdvanced Solid Tumor Cancer

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorBioNTech SE

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.