A First-in-human Clinical Trial to Test if the Investigational Drug BNT3219 is Safe and Potentially Beneficial for People With Advanced Solid Tumors When Given Alone or Together With Other Investigational Drugs

NCT07893054 | Not Yet Recruiting Phase 1

• 1 other identifier: BNT3219-01
• Study Type: interventional
• Target: 207
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will test BNT3219 (also known as PM1092) in adults with advanced solid tumors whose cancer has progressed after available standard treatments. It is the first study of BNT3219 in people, and it will test different dose levels to identify safe and tolerable doses. The study will also examine how the treatment moves through the body, whether the immune system reacts to them, and whether it shows signs of shrinking or controlling tumors.

Conditions

Advanced Solid Tumors

Keywords

Bispecific antibody; Human immunoglobulin G (IgG) 1 bispecific antibody; Immunotherapy

Outcome Measures

Primary Outcomes (4)

• Occurrence of dose-limiting toxicities (dose escalation only)

  During the dose-limiting toxicity evaluation period. Per cohort.

  Up to 21 days from the initiation of first dose of investigational medicinal product (IMP)

• Number and percentage of participants with treatment emergent adverse events (TEAEs) by TEAEs by National Cancer Institute Common Terminology Criteria for Adverse Events grading, seriousness, and relatedness

  Per cohort.

  From the time of dosing until 90 days after the last dose of IMP

• Number and percentage of participants with dose interruptions, or discontinuations of study treatment due to TEAEs

  Per cohort.

  From the first until the last dose of study treatment (up to approximately 30 months)

• Objective response rate (dose expansion only)

  Defined as the proportion of participants with confirmed complete response (CR) or partial response (PR) (per the Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\] based on the investigator's assessment) as best overall response.

  Up to 60 months

Secondary Outcomes (10)

• Pharmacokinetic (PK) assessment: Area under the curve (AUC) derived from serum concentrations of BNT3219

  Up to approximately 90 days after the last dose of IMP

• PK assessment: Maximum concentration (Cmax) derived from serum concentrations of BNT3219

  Up to approximately 90 days after the last dose of IMP

• PK assessment: Time to reach maximum (peak) serum concentration (Tmax) derived from serum concentrations of BNT3219

  Up to approximately 90 days after the last dose of IMP

• PK assessment: Elimination half-life (t1/2) derived from serum concentrations of BNT3219

  Up to approximately 90 days after the last dose of IMP

• Anti-drug antibody (ADA) prevalence

  Up to 90 days from the last dose of IMP

Study Arms (2)

Part A (dose escalation) - BNT3219 monotherapy

EXPERIMENTAL

Up to 7 dose levels of BNT3219

Drug: BNT3219

Part A (dose expansion) - BNT3219 monotherapy

EXPERIMENTAL

The RP2D dose level will be determined from the dose escalation in Part A

Drug: BNT3219

Interventions

BNT3219 DRUG

Solution for intravenous (IV) infusion

Part A (dose escalation) - BNT3219 monotherapy; Part A (dose expansion) - BNT3219 monotherapy

Eligibility Criteria

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

You may qualify if:

• Are ≥18 years of age at the time of the informed consent form signature. Local laws will be followed if the age of consent is older.
• Have histologically or cytologically confirmed locally advanced, recurrent, or metastatic solid tumors which have progressed after at least one available standard therapy; or for whom the standard therapy is considered to be ineffective, inappropriate or intolerable, or for whom no standard treatment is available.
• Must be willing to provide a tissue sample, archival or fresh, during the screening period. An archival sample less than 2 years old is only acceptable if biopsy is not feasible due to safety concerns.
• Have at least one measurable lesion based on RECIST v1.1.
• Have an Eastern Cooperative Oncology Group performance status of 0 (fully active, able to carry out all pre-disease activities without restriction) or 1 (unable to perform physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature).
• Have a predicted life expectancy of ≥3 months.
• Have a left ventricular ejection fraction of ≥50% by either echocardiogram or multi-gated acquisition scan within 28 days prior to first dose of study treatment.
• Have an adequate liver, renal, hematological, and coagulation function as defined by the protocol.
• Have recovered to Grade 1 or baseline from adverse reactions related to prior anticancer therapy except for toxicity that the investigator determined to have no safety risk, such as alopecia, Grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement therapy, etc.
• The investigator considers discontinuation of protocol-specified anticancer therapies and restricted medications with protocol-specified washout periods prior to the first dose of study treatment as medically acceptable.

You may not qualify if:

• Have an active infection (e.g., bacterial or fungal infections or tuberculosis) requiring systemic IV treatment (e.g., severe pneumonia, bacteremia, sepsis), or any uncontrolled infection within 14 days prior to the first dose of study treatment.
• Have active central nervous system metastases and/or carcinomatous meningitis as defined in the protocol.
• Participants at imminent risk for spinal cord compression or leptomeningeal disease are not eligible.
• Have unstable pleural effusion or ascites requiring thoracentesis or paracentesis within 14 days prior to initiation of study treatment.
• Have active, or a history of, pneumonitis requiring treatment with steroids, or has active, or a history of, interstitial lung disease. Those with a history of pulmonary fibrosis or currently diagnosed with severe lung diseases such as interstitial pneumonia, pneumoconiosis, chemical pneumonitis, or any other condition resulting in significant impairment in lung function.
• Have clinically significant pulmonary complications including, but not limited to, chronic obstructive pulmonary disease, restrictive lung disease, lung injury accompanied with autoimmune disease/connective tissue disorders.
• Have a history of severe cardiovascular disease as defined in the protocol.
• Have a history of serious Grade ≥3 immune-related adverse events that led to treatment discontinuation of a prior immunotherapy. Participants with a history of Grade ≥3 that did not lead to treatment discontinuation of a prior immunotherapy may be enrolled per investigator's discretion.
• Have uncontrolled hypertension or poorly controlled diabetes as defined in the protocol within the screening period and prior to study treatment.
• Have a concurrent malignancy within 5 years prior to study enrollment except for:
• Curatively treated basal cell or squamous cell carcinoma of the skin.
• Curatively treated cervical cancer in-situ.
• Curatively treated superficial or non-invasive bladder cancer.
• Curatively treated ductal or lobular breast carcinoma in situ and not currently receiving any systemic therapy.
• Localized prostate cancer that has been treated surgically with curative intent and presumed cured.

Sponsors & Collaborators

• BioNTech SE: lead
• BioNTech (Shanghai) Pharmaceuticals Co., Ltd.: collaborator

Study Officials

• BioNTech Responsible Person

  BioNTech SE

  STUDY DIRECTOR

Central Study Contacts

BioNTech clinical trials patient information

CONTACT

+49 6131 9084; patients@biontech.de

Study Design

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

Study Record Dates

• First Submitted: October 19, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): October 1, 2030
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share