BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors

NCT04455620 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: BNT151-012019-003572-39
• Study Type: interventional
• Target: 49
• Locations: 2 countries
• Sites: 6

Brief Summary

This was an open-label, multicenter Phase I/IIa dose escalation, safety, pharmacokinetic and pharmacodynamic (PD) study of BNT151 with expansion cohorts in various solid tumor indications. The study was planned to be performed in Part 1, Part 2A, and Part 2B with adaptive design elements. Part 2 was not conducted because of the clinical study being terminated early. The monotherapy dose escalation, (Part 1) of this clinical study enrolled participants with various solid tumors that are metastatic or of advanced unresectable stage for whom there was no available standard therapy likely to confer clinical benefit, or participants who are not candidates for such available therapy. Dose escalation followed an accelerated titration design, i.e., started with single participant cohorts followed by larger participant cohorts informed by the 3+3 design. Part 1 of the study also planed to implement a dedicated biomarker cohort in BNT151 monotherapy. The biomarker cohort was planned to recruit participants at selected sites in the United States (US) only. The objective of the cohort was to observe PD activity and drug-induced changes in the blood and tumor and only to generate data for exploratory endpoints or additional research. However, the biomarker cohort was not opened, and therefore no data were generated. During combination dose escalation (Part 2A), participants with squamous cell carcinoma of head and neck, and hepatocellular carcinoma were planned to be enrolled and treated with a combination of BNT151 and pembrolizumab. Once Part 2A was completed, participants with renal cell carcinoma, non-small cell lung cancer, and triple negative breast cancer were planned to be enrolled (Part 2B) and treated with a combination of BNT151 with the respective standard of care (SoC).

Conditions

Solid Tumor

Keywords

Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Dose Limiting Toxicities (DLTs) During the DLT Evaluation Period in Part 1

  From first dose of IMP up to 21 days (Cycle 1).

• Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) Including Grade ≥3, Serious, Fatal TEAE by Relationship

  A TEAE was defined as any adverse event (AE) with an onset date on or after the first administration of IMP (if the AE was absent before the first administration of IMP) or worsened after the first administration of IMP (if the AE was present before the first administration of IMP). AEs with an onset date more than 60 days after the last administration of IMP were considered as treatment emergent only if assessed as related to IMP by the investigator. The intensity of an TEAE was graded according to the NCI CTCAE version 5.0. Grade 3=Severe, Grade 4=Life threatening, Grade 5=Death.

  From first dose of IMP through study completion, a maximum of 30 months.

• Number of Paticipants With at Least One TEAE Leading to Dose Reduction, Dose Interruption, and Treatment Discontinuation of BNT151

  A TEAE was defined as any AE with an onset date on or after the first administration of IMP (if the AE was absent before the first administration of IMP) or worsened after the first administration of IMP (if the AE was present before the first administration of IMP). AEs with an onset date more than 60 days after the last administration of IMP were considered as treatment emergent only if assessed as related to IMP by the investigator.

  From first dose of IMP through treatment completion, a maximum of 24 months.

Secondary Outcomes (3)

• Objective Response Rate (ORR)

  Through study completion, a maximum of 30 months.

• Disease Control Rate (DCR)

  Through study completion, a maximum of 30 months.

• Duration of Response (DOR)

  Through study completion, a maximum of 30 months.

Study Arms (1)

Part 1: BNT151

EXPERIMENTAL

Monotherapy dose escalation in participants with advanced solid malignancies until the MTD and/or RP2D

Biological: BNT151

Interventions

BNT151 BIOLOGICAL

intravenous (IV)

Part 1: BNT151

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological documentation of the original primary tumor via a pathology report.
• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• For Part 1:
• Histologically confirmed solid tumor that is metastatic or of advanced unresectable stage and for whom there is no available standard therapy likely to confer clinical benefit, or participant who is not a candidate for such available therapy. If there is no contraindication, participants should have exhausted all SoC therapies before entering the study, if possible.
• For all Parts:
• ≥18 years of age.
• Must sign an informed consent form (ICF) indicating that he or she understands the purpose and procedures required for the study and are willing to participate in the study prior to any study-related assessments or procedures.
• Eastern Cooperative Oncology Group performance status of 0 to 1.
• Adequate coagulation function at screening as required by the protocol.
• Adequate hematologic function at screening as required by the protocol.
• Adequate hepatic function at screening as required by the protocol.
• Adequate renal function at screening as required by the protocol.
• Able and willing to attend study visits as required by the protocol.
• Women of childbearing potential (WOCBP) must have a negative serum (beta-human chorionic gonadotropin) test/value at screening. Participants who are postmenopausal or permanently sterilized can be considered as not having reproductive potential.
• WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the entire study, until 6 months after last BNT151 treatment.

You may not qualify if:

• Use of any investigational medical product (IMP) or device within 28 days before administration of first dose of study treatment.
• Has been receiving: radiotherapy, chemotherapy, or molecularly-targeted agents or tyrosine kinase inhibitors within 2 weeks or 5 half-lives (whichever is longer) of the start of study treatment; immunotherapy/monoclonal antibodies within 3 weeks of the start of study treatment; any live vaccine within 4 weeks of the start of study treatment; nitrosoureas, antibody-drug conjugates, or radioactive isotopes within 6 weeks of the start of study treatment.
• Ongoing participation in the active treatment phase of interventional clinical study.
• Receives concurrent systemic (oral or IV) steroid therapy \>10 mg prednisone daily or its equivalent for an underlying condition.
• Has had major surgery within the 4 weeks before the first dose of BNT151.
• Ongoing or active infection requiring IV treatment with anti-infective therapy that has been administered less than 2 weeks prior to the first dose of BNT151.
• Has ongoing side effects to any prior therapy or procedures for any medical condition not recovered to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 Grade ≤1.
• Medical conditions:
• Current evidence of new or growing brain or leptomeningeal metastases during screening. Participants with known brain metastases may be eligible if they:
• had radiotherapy, surgery or stereotactic surgery for the brain metastases;
• have no neurological symptoms (excluding Grade ≤2 neuropathy);
• have stable brain metastasis on the computed tomography or magnetic resonance imaging scan within 4 weeks before signing the informed consent;
• are not undergoing acute corticosteroid therapy or steroid taper.
• Has a history of a cerebrovascular accident or transient ischemic attack less than 6 months ago.
• Effusions (pleural, pericardial, or ascites) requiring drainage.

Sponsors & Collaborators

• BioNTech SE: lead

Study Sites (6)

Yale Cancer Center

New Haven, Connecticut, 06510, United States

Location

Sarah Cannon Research Institute at Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

NEXT Oncology

San Antonio, Texas, 78229, United States

Location

Vall d´Hebron Institute of Oncology (VHIO)

Barcelona, 08035, Spain

Location

START Madrid - HM CIOCC

Madrid, 28050, Spain

Location

Results Point of Contact

• Title: BioNTech clinical trials patient information
• Organization: BioNTech SE

patients@biontech.de

+49 6131 9084

Study Officials

• BioNTech Responsible Person

  BioNTech SE

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Study Start: January 26, 2021
• Primary Completion: May 28, 2024
• Study Completion: May 28, 2024
• Last Updated: July 2, 2025
• Results First Posted: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2); US (4)