Advanced Solid TumorsPhase 1NCT07893054
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
A Phase 1 study testing BNT3219 in people with Advanced Solid Tumors, run by BioNTech SE.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- BNT3219
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Oct 2030
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Localized papillary carcinoma of thyroid that has been treated surgically with curative intent and presumed cured.
- Have had an unstable thrombotic event (e.g., deep vein thrombosis, arterial thrombosis, pulmonary embolism) requiring therapeutic intervention within 3 months.
- Have known human immunodeficiency virus infection or known acquired immunodeficiency syndrome (exceptions apply).
- Have an active hepatitis B virus (HBV) infection (chronic or acute; defined as having a positive hepatitis B surface antigen test result at screening). However, participants with known HBV infection or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of hepatitis B surface antigen) are eligible only if they are negative for HBV deoxyribonucleic acid (DNA) (HBV viral load is below the limit of quantification per local laboratory).
- Have an active hepatitis C virus (HCV) infection. Participants with a negative HCV antibody test at screening or positive HCV antibody test followed by a negative HCV ribonucleic acid test at screening are eligible. Participants who have completed curative antiviral treatment with HCV viral load below the limit of quantification are allowed.
- Have received systemic corticosteroids, live attenuated vaccine(s) or drugs within protocol-specified requirements prior to study treatment.
- Have active tuberculosis or an active syphilis infection.
- NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I/Ib, First-in-human, Open-label, Multi-site, Multi-regional, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of BNT3219 Monotherapy or BNT3219 in Combination With Other Investigational Therapies in Participants With Advanced Solid Tumors
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.
Read the detailed description
This study will initiate with Part A which will consist of a dose escalation and dose expansion of BNT3219 monotherapy. The dose expansion will be conducted in some specific indications with the recommended phase II dose (RP2D) generated from the dose escalation.
The sponsor will analyze all available data from Part A and may decide to continue the study with Part B to investigate BNT3219 in combination with other investigational therapies.
There will be a Screening Period, a Treatment Period, and a Follow-up Period (including an end-of-treatment visit, two safety follow-up visits, and a survival follow-up period with regular visits).
Participants will remain in the survival follow-up period until death, lost to follow-up, withdrawal of consent, or until the sponsor terminates the study, whichever occurs first.
- Conditions
- Advanced Solid Tumors
- Being tested
- BNT3219
- Keywords
- Bispecific antibody, Human immunoglobulin G (IgG) 1 bispecific antibody, Immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNT3219Drug
Solution for intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| Part A (dose escalation) - BNT3219 monotherapy | Experimental | Up to 7 dose levels of BNT3219 Receives: Drug: BNT3219 |
| Part A (dose expansion) - BNT3219 monotherapy | Experimental | The RP2D dose level will be determined from the dose escalation in Part A Receives: Drug: BNT3219 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of dose-limiting toxicities (dose escalation only)
During the dose-limiting toxicity evaluation period. Per cohort.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 60 months
Secondary outcomes (10)
Pharmacokinetic (PK) assessment: Area under the curve (AUC) derived from serum concentrations of BNT3219
After single- and multiple-dosing. Per cohort. As data permits.
Measured: Up to approximately 90 days after the last dose of IMP
PK assessment: Maximum concentration (Cmax) derived from serum concentrations of BNT3219
After single- and multiple-dosing. Per cohort. As data permits.
Measured: 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
After single- and multiple-dosing. Per cohort. As data permits.
Measured: Up to approximately 90 days after the last dose of IMP
PK assessment: Elimination half-life (t1/2) derived from serum concentrations of BNT3219
After single- and multiple-dosing. Per cohort. As data permits.
Measured: Up to approximately 90 days after the last dose of IMP
Anti-drug antibody (ADA) prevalence
Defined as the proportion of participants who are ADA positive (either baseline or post baseline). Per cohort. As data permits.
Measured: Up to 90 days from the last dose of IMP
ADA incidence
Defined as the proportion of participants having treatment-emergent ADA. Per cohort. As data permits.
Measured: Up to 90 days from the last dose of IMP
Objective response rate (dose escalation only)
Defined as the proportion of participants in whom a confirmed CR or PR (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1] based on the investigator's assessment) is observed as best overall response. Per cohort.
Measured: Up to 60 months
Disease control rate
Defined as the proportion of participants in whom confirmed CR, PR, or stable disease (per RECIST v1.1 based on the investigator's assessment) is observed as best overall response. Per cohort.
Measured: Up to 60 months
Duration of response
Defined as the time from first confirmed objective response (CR or PR based on investigator's assessment per RECIST v1.1) to first occurrence of objective tumor progression (progressive disease based on investigator's assessment per RECIST v1.1) or death from any cause, whichever occurs first. Per cohort.
Measured: Up to 60 months
Time to response
Defined as the time from first dose of study treatment to first confirmed objective response (CR or PR per RECIST v1.1 based on the investigator's assessment) in participants with a confirmed objective response. Per cohort.
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionJul 2029 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by BioNTech SEThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 207 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioNTech SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioNTech (Shanghai) Pharmaceuticals Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- BioNTech Responsible Person, Study director, BioNTech SE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893054
- Sponsor's protocol ID
- BNT3219-01
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No