A Phase I/II, first-in-human, open-label, dose escalation and indication expansion study of the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of BNT3212 as monotherapy or in combination with BNT327 in adults with advanced solid tumors (NCT07147348)

The aim of this first-in-human (FIH) open-label, multi-site study is to evaluate safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary clinical efficacy of BNT3212, including identification of the recommended dose of BNT3212 for use as monotherapy and with BNT327 as combination therapy, in adults with advanced solid tumors who have exhausted other treatment options.

Trial phase

Phase 1

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Dr Ben Markman

Key inclusion data

Participants with histologically or cytologically confirmed locally advanced, recurrent, or metastatic solid tumors that have progressed after at least one available standard therapy; or for whom the standard therapy is considered inappropriate or intolerable.