NCT04710043

Dose Escalation Trial of BNT152+153 in Patients With Cancer

Phase I, First-in-human, Open-label, Dose Escalation Trial to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of BNT152+153 in Patients With Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multisite Phase I dose escalation, safety, pharmacokinetics (PK) and pharmacodynamics (PD) trial of BNT152+153 in various solid tumor indications. The clinical trial will enroll patients with various solid tumors that are metastatic or unresectable for whom there is no available standard therapy likely to confer clinical benefit, or patients who are not candidates for such available therapy. The trial consists of Part 1 and Part 2 with adaptive design elements: * Part 1 consists of Groups A and B. * Group A is a BNT153 monotherapy dose escalation in patients with advanced solid malignancies until the maximal tolerated dose (MTD) is defined. If MTD is not reached, maximum administered dose (MAD) may be used for further development (or another dose as determined by the safety review committee \[SRC\]). * Group B is a BNT152 monotherapy dose escalation in patients with advanced solid malignancies until the MTD or optimal biological dose (OBD; the lowest safe dose associated with optimal biological activity) is defined, whichever occurs earlier. * Group A will be activated first while the time point for Group B activation is at sponsor's decision. * Part 2 will start after the MTD or MAD or another dose as determined by the SRC have been established for BNT153 and MTD or OBD for BNT152 in Part 1. Part 2 (Part 2A, 2B and 2C) is a dose escalation of BNT152+153 in patients with advanced solid malignancies until the recommended Phase II dose (RP2D) is defined. * Part 2 may implement a biomarker cohort if a clinical benefit is observed at one or more doses of BNT152+153 that show a clear PD effect in the peripheral blood. The Biomarker Cohort will recruit patients at selected sites.

Detailed description

The Part 2 starts with Part 2A. Enrollment of Part 2B begins after dose level 1 in Part 2A is deemed safe by the SRC. The dose escalation in Part 2A continues as described in the protocol. The dose escalation in Part 2B continues as described in the protocol until RP2D is determined. To further investigate the effect of BNT152+153, Part 2C may be introduced upon review of the emerging data.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	BNT152	intravenous
DRUG	BNT153	intravenous

Timeline

• Start date: 2021-06-08
• Primary completion: 2025-09-10
• Completion: 2025-09-10
• First posted: 2021-01-14
• Last updated: 2025-09-25

Locations

7 sites across 2 countries: United States, Czechia

Regulatory

• FDA-regulated drug study