Solid TumorPhase 1/2NCT04455620
BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors
A Phase 1/2 study testing BNT151 in people with Solid Tumor, run by BioNTech SE at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- BNT151
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 26 Jan 2021to 28 May 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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.
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- 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.
- A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control, e.g. either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 6 months after receiving the last dose of BNT151.
- WOCBP must agree to use highly effective contraception during the study and for 6 months after receiving the last dose of BNT151. Birth control methods are considered highly effective if they have a failure rate of less than 1% per year, when used consistently and correctly.
- Biomarker cohort: At selected US sites only: at enrollment participants must agree to have one pre-dose biopsy and lesion that is deemed accessible by the investigator. If possible, at least one on-treatment biopsy should be accessible from same tumor lesion.
Who cannot join
- 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.
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- 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.
- History of autoimmune disease active or past including but not limited to inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. Has any active immunologic disorder requiring immunosuppression with steroids or other immunosuppressive agents (e.g., azathioprine, cyclosporine A) with the exception of participants with isolated vitiligo, resolved childhood asthma or atopic dermatitis, controlled hypoadrenalism or hypopituitarism, and participants with a history of Grave's disease with stable thyroid function. Participants with controlled hyperthyroidism must be negative for thyroglobulin, thyroid peroxidase antibodies, and thyroid stimulating immunoglobulin prior to administration of study treatment.
- Known history of seropositivity for human immunodeficiency virus (HIV) with CD4+ T-cell (CD4+) counts <350 cells/µL and with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections.
- Known history/positive serology for hepatitis B requiring active antiviral therapy (unless immune due to vaccination or resolved natural infection or unless passive immunization due to immunoglobulin therapy). Participants with positive serology must have hepatitis B viral load below the limit of quantification.
- Active hepatitis C virus (HCV) infection; participants who have completed curative antiviral treatment with HCV viral load below the limit of quantification are allowed.
- Any contraindication to the combination therapies as per United States Prescribing Information or Summary of Product Characteristics for participants receiving BNT151 in combination with other systemic anticancer agent(s).
- Another primary malignancy that has not been in remission for at least 2 years, with the exception of those with a negligible risk of metastasis or death (including but not limited to adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ).
- Other comorbidities:
- Abnormal electrocardiograms that are clinically significant, such as Fridericia-corrected QT prolongation >480 ms.
- In the opinion of the treating investigator, has any concurrent conditions that could pose an undue medical hazard or interfere with the interpretation of the study results; these conditions include, but are not limited to:
- Ongoing or active infection requiring antibiotic/antiviral/antifungal therapy
- Concurrent congestive heart failure (New York Heart Association Functional Classification Class III or IV)
- Concurrent unstable angina
- Concurrent cardiac arrhythmia requiring treatment (excluding asymptomatic atrial fibrillation)
- Acute coronary syndrome within the previous 6 months
- Pulmonary embolism within the previous 3 months
- Significant pulmonary disease (shortness of breath at rest or on mild exertion) for example due concurrent severe obstructive pulmonary disease.
- Cognitive, psychological or psychosocial impediment that would impair the ability of the participant to receive therapy according to the protocol or adversely affect the ability of the participant to comply with the informed consent process, protocol, or protocol-required visits and procedures.
- Is pregnant or breastfeeding.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States4 sites
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Sarah Cannon Research Institute at Tennessee Oncology
Nashville, Tennessee, 37203
Yale Cancer Center
New Haven, Connecticut, 06510
NEXT Oncology
San Antonio, Texas, 78229
Spain2 sites
Vall d´Hebron Institute of Oncology (VHIO)
Barcelona, 08035
START Madrid - HM CIOCC
Madrid, 28050
About this study
Official title: Phase I/IIa, First-in-human, Open-label, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors
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.
Read more
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).
Read the detailed description
The study was terminated early due to sponsor's decision after careful considerations including recruitment projections and available data, and not due to any safety concerns. At the time of the termination, fewer dose levels were tested than anticipated.
- Conditions
- Solid Tumor
- Being tested
- BNT151
- Keywords
- Solid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNT151Biological
intravenous (IV)
| Study group | Role | What they receive |
|---|---|---|
| Part 1: BNT151 | Experimental | Monotherapy dose escalation in participants with advanced solid malignancies until the MTD and/or RP2D Receives: Biological: BNT151 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose Limiting Toxicities (DLTs) During the DLT Evaluation Period in Part 1
Measured: 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.
Measured: 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.
Measured: From first dose of IMP through treatment completion, a maximum of 24 months.
Secondary outcomes (3)
Objective Response Rate (ORR)
ORR was defined as the proportion of participants in whom a complete response (CR) or partial response (PR) (per RECIST version 1.1) was observed as best overall response.
Confirmed ORR was defined as the proportion of participants in whom a CR or PR (per RECIST version 1.1) was observed as best overall response and has been confirmed with a subsequent assessment of objective response at least 4 weeks apart.
Measured: Through study completion, a maximum of 30 months.
Disease Control Rate (DCR)
DCR was defined as the proportion of participants in whom a CR or PR or stable disease (SD) (per RECIST version 1.1, SD assessed at least 6 weeks after first dose) was observed as best overall response.
Measured: Through study completion, a maximum of 30 months.
Duration of Response (DOR)
DOR was defined as the time from first objective response (CR or PR per RECIST version 1.1) to first occurrence of objective tumor progression (progressive disease per RECIST version 1.1) or death from any cause, whichever occurred first.
Reporting groups with zero participants with confirmed objective response are not included.
Measured: Through study completion, a maximum of 30 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start26 Jan 2021
- Primary completion28 May 2024
- Study completion28 May 2024
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Solid TumorStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioNTech SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- BioNTech Responsible Person, Study director, BioNTech SE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455620
- Sponsor's protocol ID
- BNT151-01
- Other IDs
- 2019-003572-39, 2019
- Status last verified
- Jun 2025
- First submitted
- 29 Jun 2020
- Last updated
- 2 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/IIa, First-in-human, Open-label, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT04455620
- Acronym / sponsor ID
- BNT151-01
- Conditions
- Solid Tumor
- Keywords
- Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 49 participants (actual)
- Lead sponsor
- BioNTech SEIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 2 Jul 2020 (actual)
- Results
- Posted 2 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The study was terminated early due to sponsor's decision after careful considerations including recruitment projections and available data, and not due to any safety concerns. At the time of the termination, fewer dose levels were tested than anticipated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Part 1: BNT151 | Experimental | Biological: BNT151Monotherapy dose escalation in participants with advanced solid malignancies until the MTD and/or RP2D |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histological documentation of the original primary tumor via a pathology report.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- 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.
- ≥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.
Key exclusion criteria (33 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BNT151intravenous (IV) | Biological | Part 1: BNT151 |
Primary outcome
Number of Participants With Dose Limiting Toxicities (DLTs) During the DLT Evaluation Period in Part 1
Time frame: 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
Time frame: From first dose of IMP through study completion, a maximum of 30 months.
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.
Number of Paticipants With at Least One TEAE Leading to Dose Reduction, Dose Interruption, and Treatment Discontinuation of BNT151
Time frame: From first dose of IMP through treatment completion, a maximum of 24 months.
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.
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: Through study completion, a maximum of 30 months.
Disease Control Rate (DCR)
Time frame: Through study completion, a maximum of 30 months.
Duration of Response (DOR)
Time frame: Through study completion, a maximum of 30 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BioNTech Responsible Person study director
BioNTech SE
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BNT151 in people with Solid Tumor, run by BioNTech SE at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose Limiting Toxicities (DLTs) During the DLT Evaluation Period in Part 1 (time frame: From first dose of IMP up to 21 days (Cycle 1).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.