Safety and Preliminary Efficacy of BNT314 in Cancer Patients With Malignant Solid Tumors

NCT06150183 | Active Not Recruiting Phase 1 FDA Drug

• 3 other identifiers: BNT314-012023-506053-38-001008686
• Study Type: interventional
• Target: 41
• Locations: 6 countries
• Sites: 14

Brief Summary

The purpose of this first-in-human study is to find out if BNT314 is safe when it is used alone in patients with different types of cancer. This is a dose escalation study in which patients will be assigned to multiple dose levels (DLs) of BNT314 given alone. By escalating the dose with a small group of patients, the Maximum Tolerated Dose which is the highest dose with acceptable safety and manageable side effects, or the maximum administered dose will be investigated.

Conditions

Advanced Malignant Solid Tumor

Keywords

Malignant solid tumors

Outcome Measures

Primary Outcomes (4)

• Occurrence of dose-limiting toxicity within a cohort

  21 days from the first dose administration

• Number and percentage of patients with occurrence of treatment-emergent adverse events (TEAEs) including Grade ≥ 3, serious, fatal TEAE by relationship

  In patients receiving at least one dose of BNT314 per cohort

  from first dose of study treatment to 90 days after last dose of study treatment

• Number and percentage of patients with occurrence of dose reduction and discontinuation of investigational medicinal product (IMP) due to TEAE

  In patients receiving at least one dose of BNT314 per cohort

  from first dose of study treatment to 90 days after last dose of study treatment

• Number and percentage of patients with occurrence of Grade ≥ 3 abnormal safety laboratory parameters

  In patients receiving at least one dose of BNT314 per cohort

  from first dose of study treatment to 90 days after last dose of study treatment

Secondary Outcomes (7)

• Geometric means of area under the concentration-time curve from pre-dose to last quantifiable time point prior to the next dose (AUClast)

  from pre-dose to 21 days after study treatment for Cycle 1 and Cycle 2

• Geometric means of area under the concentration-time curve from pre-dose to the end of the dosing period (AUCtau)

  from pre-dose to 21 days after study treatment for Cycle 1 and Cycle 2

• Geometric means of maximum concentration (Cmax) from pre-dose to the end of the dosing period

  from pre-dose to 21 days after study treatment for Cycle 1 and Cycle 2

• Number and percentage of patients who developed detectable anti-drug antibody from baseline to the end of study treatment

  from pre-dose to 90 days after last dose of study treatment

• Disease control rate based on investigator's tumor assessment according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

  up to 3 years after first dose of study treatment

Study Arms (1)

BNT314 Monotherapy

EXPERIMENTAL

Escalating dose levels and backfill cohorts

Biological: BNT314

Interventions

BNT314 BIOLOGICAL

Intravenous infusion

BNT314 Monotherapy

Eligibility Criteria

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

You may qualify if:

• Have the ability to voluntarily give informed consent by signing and dating the informed consent form (ICF) before initiation of any study-specific procedures.
• Are willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions, and other requirements of the study. This includes that they are able to understand and follow study-related instructions.
• Are ≥18 years of age at the time of giving informed consent.
• Have measurable disease according to RECIST v1.1.
• Have a life expectancy of \>3 months.
• Have Eastern Cooperative Oncology Group Performance Status score of 0 or 1 at screening.
• Have adequate coagulation function at screening as determined by:
• International normalized ratio or prothrombin time ≤1.5 × upper limit normal (ULN; unless on therapeutic anticoagulants with values within therapeutic window).
• Activated partial thromboplastin time ≤1.5 × ULN (unless on therapeutic anticoagulants with values within therapeutic window).
• Have adequate bone marrow/hematologic function at screening as determined by:
• Absolute neutrophil count (ANC) ≥1.5 × 10\^9/L (≥1500/μL) (patients may not use granulocyte colony stimulating factor or granulocyte-macrophage colony stimulating factor to achieve these ANC levels in the past 7 days).
• Platelet count ≥100 × 10\^9/L (≥100,000/μL).
• Hemoglobin ≥9 g/dL.
• Any blood transfusions ≤28 days before first dose of study treatment should be documented.
• Have adequate hepatic function at screening as determined by:

You may not qualify if:

• Patients that have uncontrolled intercurrent illness, including but not limited to:
• Ongoing or active infection requiring treatment with anti-infective therapy administered less than 2 weeks prior to first dose.
• Symptomatic congestive heart failure (Grade III or IV as classified by the New York Heart Association), unstable angina pectoris, or symptomatic untreated cardiac arrhythmia. Treated and/or asymptomatic cardiac arrythmia/atrial fibrillation will be allowed.
• History of arterial thrombosis or pulmonary embolism within 6 months before the first dose of study treatment.
• History of myocardial infarction within 6 months before the first dose of study treatment.
• Uncontrolled hypertension defined as systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg, despite optimal medical management.
• Prolonged QTc interval at baseline of ≥470 milliseconds using Fridericia's QT correction formula.
• Ongoing or recent (within one year of screening) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events.
• History of:
• Grade 2 immune-mediated myocarditis/colitis/pneumonitis that led to checkpoint inhibitor (CPI) discontinuation. Patients experiencing other Grade 2 immune-mediated adverse events that led to CPI discontinuation, require discussion with the sponsor.
• Any Grade ≥3 immune-mediated adverse events that led to CPI discontinuation.
• Patients with Grade 3 adverse events that led to CPI discontinuation but resolved within 21 days without sequalae may also be considered for discussion with the sponsor.
• History of chronic liver disease (e.g., alcoholic hepatitis or nonalcoholic steatohepatitis, drug-related or autoimmune hepatitis) or evidence of hepatic cirrhosis.
• History of non-treated intracerebral arteriovenous malformation (shunts), non-treated cerebral aneurysm, spinal cord compression (from disease), carcinomatous meningitis, or stroke will be excluded.
• History of acute or chronic pancreatitis of any etiology within 6 weeks prior to the start of study treatment.

Sponsors & Collaborators

• BioNTech SE: lead
• Genmab: collaborator

Study Sites (14)

START Midwest

Grand Rapids, Michigan, 49546, United States

Location

Carolina BioOncology Institute, LLC

Huntersville, North Carolina, 28078, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

GZA Ziekenhuizen

Antwerp, 2018, Belgium

Location

CHU de Liège

Liège, 4000, Belgium

Location

Rigshospitalet

Copenhagen, DK-2100, Denmark

Location

National Cancer Center Hospital East

Kashiwanoha, 277-8577, Japan

Location

Hospital Quironsalud Barcelona (NEXT Barcelona)

Barcelona, 08023, Spain

Location

Hospital Fund. Jiménez Dia

Madrid, 28040, Spain

Location

Hospital HM Univ. Sanchinarro, Ensayos START

Madrid, 28050, Spain

Location

Clinica Universidad de Navarra

Pamplona, 31008, Spain

Location

Royal Marsden Hospital - London

London, SW36JJ, United Kingdom

Location

The Christie Hospital

Manchester, M20 4BX, United Kingdom

Location

Northern Centre for Cancer Care

Newcastle, NE7 7DN, United Kingdom

Location

Study Officials

• BioNTech Responsible Person

  BioNTech SE

  STUDY DIRECTOR

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: November 21, 2023
• First Posted: November 29, 2023
• Study Start: November 30, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); ES (4); BE (2); GB (3); US (3); JP (1)