NCT07147348

A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 375 (estimated)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 pumitamig (also known as BNT327 or PM8002) as combination therapy, in adults with advanced solid tumors who have exhausted other treatment options.

Detailed description

This study will include four parts: * Part A (BNT3212 monotherapy - dose escalation) * Part B (BNT3212 monotherapy - dose expansion cohorts) * Part C (BNT3212 + pumitamig combination therapy - dose escalation) * Part D (BNT3212 + pumitamig combination therapy - dose expansion cohorts) This study will follow a stepwise approach, beginning with a typical dose escalation in advanced solid tumors, followed by dose expansion in a range of indications. This design allows to gradually assess safety, preliminary efficacy, potential recommended Phase 2 dose (RP2D), and indications, while ensuring an acceptable benefit-risk balance along the way. Throughout this process, clinical data, including PK, biomarker, immunogenicity, safety, and efficacy, as well as non-clinical data, will be continuously collected and evaluated to support decision-making and ensure participant safety.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	BNT3212	Intravenous infusion
BIOLOGICAL	Pumitamig	Intravenous infusion

Timeline

• Start date: 2025-08-27
• Primary completion: 2027-11-01
• Completion: 2028-08-01
• First posted: 2025-08-29
• Last updated: 2026-04-06

Locations

16 sites across 2 countries: Australia, China