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AzTrials

Advanced Lung CancerPhase 1/2NCT06892548

A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer

A Phase 1/2 study testing BNT324 and BNT327 in people with Advanced Lung Cancer, run by BioNTech SE at 91 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study aims to investigate the combination of BNT324, a B7-H3 antibody-drug conjugate (ADC) with BNT327, a programmed death-ligand 1 (PD-L1) and vascular endothelial growth factor (VEGF) bispecific antibody, in participants with advanced/metastatic or relapsed/progressive small cell lung cancer (SCLC) and non… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Lung Cancer
What is being tested?
BNT324 and BNT327
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
594 participants
Where
91 sitesin 10 countries
Study dates
2 May 2025to May 2032
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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

  • Aged ≥18 years at the time of giving informed consent.
  • Histological or cytological confirmed unresectable advanced/metastatic lung cancer. Histological classification may be based on tumor samples prior to metastatic disease. Participants with mixed histology must be classified based on the main component. Participants with NSCLC are eligible with any or no PD-L1 expression. Participants with AGA-positive disease must have received targeted therapy prior to enrollment in this study.
  • Part 1: Participants with NSCLC and SCLC
  • Part 2 Cohort 1: Participants with NSCLC (subpopulation 1) AGA negative, 1L
  • Part 2 Cohort 2: Participants with SCLC, 2L+
  • Part 2 Cohort 3: Participants with NSCLC (subpopulation 1) AGA negative, 2L+
Show all 13Show fewer
  • Part 2 Cohort 4: Participants with NSCLC (subpopulation 2) AGA negative, 1L
  • Part 2 Cohort 5: Participants with NSCLC (subpopulation 2) AGA negative, 2L+
  • Part 2 Cohort 6: Participants with NSCLC AGA positive
  • Part 2 Cohort 7: Participants with SCLC, 1L
  • Have measurable disease defined by RECIST version 1.1.
  • Have an Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Have a life expectancy of ≥12 weeks.

Who cannot join

  • Prior treatment with B7-H3 targeted therapy.
  • Prior treatment with ADC with topoisomerase inhibitor (e.g., datopotamab deruxtecan, trastuzumab deruxtecan). Note: This exclusion applies to participants in the first-line/treatment-naïve cohorts in the advanced/metastatic setting. Prior treatment with ADC with topoisomerase inhibitor payload is only allowed for participants in the second-line plus cohorts in the advanced/metastatic setting.
  • Is a candidate to locoregional treatment (including surgical resection, stereotactic radiotherapy or tumor ablation) with potential to induce complete or near complete response and prolonged tumor control (sometimes described as "radical" intent), per investigator's assessment.
  • Has a history of significant hematologic toxicity to prior lines of therapy, as assessed by investigator, e.g., Grade 4 febrile neutropenia or recurrent/persistent Grade 3 to 4 neutropenia.
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply to all or some participants depending on the cohort.

Trial locations and contacts

91 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

BioNTech clinical trials patient information contact

+49 6131 9084 ext. 0

patients@biontech.de

91 sites in 10 countries

China29 sites, 29 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Recruiting

  • Beijing GoBroad Hospital

    Beijing, Beijing Municipality, 102200

    Recruiting

  • Jilin Cancer Hospital

    Changchun, Jilin, 130000

    Recruiting

  • Hunan Province People's Hospital

    Changsha, Hunan, 410005

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 611100

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Fujian, 361003

    Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

    Recruiting

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    Guandong, 510095

    Recruiting

  • First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

    Recruiting

  • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

    Hangzhou, Zhejiang, 310016

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    Recruiting

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui, 230088

    Recruiting

  • Jinan Central Hospital

    Jinan, Shandong, 250013

    Recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

    Recruiting

  • Jingzhou First People's Hospital

    Jingzhou, Hubei, 434000

    Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Recruiting

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi, 330209

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330209

    Recruiting

  • Nanjing Chest Hospital

    Nanjing, Jiangsu, 210029

    Recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi Zhuang, 530021

    Recruiting

  • Linyi Cancer Hospital

    Shandong, Linyi, 276001

    Recruiting

  • Shanghai GoBroad Cancer Hospital

    Shanghai, Shanghai Municipality, 200125

    Recruiting

  • The First Affiliated Hospital of Xinxiang Medical University

    Weihui, Henan, 453100

    Recruiting

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, Shaanxi, 710061

    Recruiting

  • Xiangyang Central Hospital

    Xiangyang, Hubei, 441021

    Recruiting

  • Xuzhou Central Hospital

    Xuzhou, 221018

    Recruiting

  • Yichang Central People's Hospital

    Yichang, Hubei, 443000

    Recruiting

  • Henan Provincial Cancer Hospital

    Zhengzhou, Henan, 450003

    Recruiting

Other trials in China

United States17 sites, 17 recruiting

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

    Recruiting

  • Regional Cancer Care Associates

    Belleville, New Jersey, 07109

    Recruiting

  • Precision NextGen Oncology and Research Center

    Beverly Hills, California, 90212

    Recruiting

  • Cleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer Center

    Cleveland, Ohio, 44195

    Recruiting

  • Texas Oncology - DFW

    Dallas, Texas, 75246

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Recruiting

  • John Theurer Cancer Center at Hackensack UMC

    Hackensack, New Jersey, 07601

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • University of Iowa Hospitals & Clinics PARENT

    Iowa City, Iowa, 52242

    Recruiting

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224

    Recruiting

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

    Recruiting

  • Memorial Sloan Kettering Cancer Center (MSKCC)

    New York, New York, 10021

    Recruiting

  • Icahn School of Medicine at Mount Sinai PRIME

    New York, New York, 10029

    Recruiting

  • Mayo Clinic Arizona

    Phoenix, Arizona, 13400

    Recruiting

  • Mayo Clinic-Rochester

    Rochester, Minnesota, 55905

    Recruiting

  • UCLA - David Geffen School of Medicine

    Santa Monica, California, 90404

    Recruiting

  • Texas Oncology - Northeast

    Tyler, Texas, 75702

    Recruiting

Other trials in United States

Spain8 sites, 8 recruiting

  • Hospital Universitari Dexeus

    Barcelona, 08028

    Recruiting

  • Clinica Universidad de Navarra

    Barcelona, 08036

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08740

    Recruiting

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

    Recruiting

  • Hospital Quironsalud Malaga

    Málaga, 29004

    Recruiting

  • Hospital Universitario Nuestra Señora de Valme

    Seville, 41014

    Recruiting

  • Hospital Universitario de Torrejón

    Torrejón de Ardoz, 28850

    Recruiting

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

    Recruiting

Other trials in Spain

Turkey (Türkiye)7 sites, 7 recruiting

  • Adana City Hospital

    Adana, 01230

    Recruiting

  • Hacettepe University Medical Faculty

    Ankara, 06100

    Recruiting

  • Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital

    Ankara, 06105

    Recruiting

  • Ankara City Hospital

    Ankara, 06800

    Recruiting

  • Yeditepe University Medical School Hospital

    Istanbul, 31755

    Recruiting

  • Koc University Hospital

    Istanbul, 34010

    Recruiting

  • Sakarya Training and Research Hospital

    Sakarya, 54187

    Recruiting

Other trials in Turkey (Türkiye)

United Kingdom7 sites, 7 recruiting

  • Bristol Haematology and Oncology Centre

    Bristol, BS2 8ED

    Recruiting

  • St. James's University Hospital

    Leeds, LS97TF

    Recruiting

  • The Clatterbridge Cancer Center

    Liverpool, L7 8YA

    Recruiting

  • St George's Hospitals NHS Foundation Trust

    London, SW170QT

    Recruiting

  • University College London Hospital

    London, W1T 7HA

    Recruiting

  • The Christie NHS Foundation Trust

    Manchester, M204BX

    Recruiting

  • Royal Preston Hospital

    Preston, PR29HT

    Recruiting

Other trials in United Kingdom

Australia6 sites, 6 recruiting

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

    Recruiting

  • Bendigo Hospital

    Bendigo, Victoria, 3550

    Recruiting

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

    Recruiting

  • Barwon Health

    Geelong, Victoria, 3220

    Recruiting

  • Sunshine Hospital

    Saint Albans, Victoria, 3021

    Recruiting

  • St John of God Subiaco Hospital

    Subiaco, Western Australia, 6008

    Recruiting

Other trials in Australia

Italy5 sites, 5 recruiting

  • IRCCS Istituto di Candiolo

    Candiolo, 10060

    Recruiting

  • IRCCS Ospedale San Raffaele

    Milan, 20132

    Recruiting

  • Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"

    Naples, 80131

    Recruiting

  • Istituto Nazionale Tumori Regina Elena IRCCS

    Roma, 00144

    Recruiting

  • Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)

    Verona, 37134

    Recruiting

Other trials in Italy

Taiwan5 sites, 5 recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

    Recruiting

  • Taichung Veterans General Hospital

    Taichung, 40705

    Recruiting

  • National Cheng Kung University Hospital

    Tainan, 704

    Recruiting

  • National Taiwan University Cancer Center

    Taipei, 106

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    Recruiting

Other trials in Taiwan

France4 sites, 4 recruiting

  • Centre Hospitalier Intercommunal de Créteil

    Créteil, 94000

    Recruiting

  • Assistance Publique-Hôpitaux de Marseille

    Marseille, 13005

    Recruiting

  • Hôpital Foch

    Suresnes, 92151

    Recruiting

  • Hopital Larrey

    Toulouse, 31059

    Recruiting

Other trials in France

Poland3 sites, 3 recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

    Recruiting

  • Pratia Onkologia Katowice

    Katowice, 40-519

    Recruiting

  • Centrum Medyczne Pratia Poznań

    Poznan, 60-192

    Recruiting

Other trials in Poland

About this study

Official title: A Phase Ib/II, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Recommended Combination Dose of BNT324 With BNT327 in Participants With Advanced Lung Cancer

This study aims to investigate the combination of BNT324, a B7-H3 antibody-drug conjugate (ADC) with BNT327, a programmed death-ligand 1 (PD-L1) and vascular endothelial growth factor (VEGF) bispecific antibody, in participants with advanced/metastatic or relapsed/progressive small cell lung cancer (SCLC) and non small cell lung cancer (NSCLC).

Read the detailed description

This is a two-part study designed to evaluate and establish two safe combination dose levels (recommended Phase 2 dose [RP2D] and a lower/another combination dose level [RP2D-1]) of BNT324 with BNT327 (Part 1), to determine the optimal combination dose (dose optimization [DO]) in NSCLC and SCLC lead indication cohorts at the RP2D and RP2D-1, to evaluate the preliminary efficacy in selected lung cancer cohorts at the highest combination dose level (in a signal seeking Part 2), and to confirm the clinical efficacy of BNT324 in combination with BNT327 at the optimal dose level in participants with advanced lung cancer in expansion cohorts (proof-of-concept [POC] cohorts).

The study consists of a screening period, a treatment period, a safety follow-up period, and a long-term survival follow-up period.

In Part 1 participants with histologically or cytologically confirmed relapsed or progressive lung cancer (both SCLC and NSCLC are eligible) will receive BNT324 in combination with BNT327 using a dose escalation design.

In Part 2 of the study, BNT324 will be studied in combination with BNT327 at the RP2D compared to RP2D-1 in participants with advanced metastatic treatment-naïve NSCLC (DO Cohort 1) and relapsed/progressive SCLC after failure of cytotoxic chemotherapy with or without immuno-oncology (IO) (DO Cohort 2). The totality of the available data (e.g., safety, efficacy, pharmacokinetics etc.) will be reviewed to select the optimal dose. After the optimal dose is selected, additional participants in each cohort may be enrolled in the selected optimal dose.

In the signal seeking cohorts (Cohort 3-7), participants will receive BNT324 in combination with BNT327 at the RP2D from Part 1.

A predefined number of participants in Part 2 Cohort 1 and Cohort 2 will be randomized to one of the two dose levels (RP2D and RP2D-1) selected from Part 1 in a 1:1 ratio. Additional participants in Part 2 Cohort 1 and Cohort 2 may be enrolled in the selected optimal dose to further assess the efficacy and safety profile.

No randomization is planned for any other cohort in Part 2 or Part 1.

Being tested
BNT324, BNT327
Keywords
Small cell lung cancer (SCLC), Non-small cell lung cancer (NSCLC), Programmed death-ligand 1 (PD-L1), Vascular endothelial growth factor (VEGF), Bispecific antibody, BNT324 (DB-1311), BNT327, Combination with chemotherapy, Combination with other investigational agents, Immunotherapy, Treatment-naïve
Medical subject headings
Small Cell Lung Carcinoma, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BNT324Biological

    Also called DB-1311

    Intravenous infusion

  • BNT327Biological

    Intravenous infusion

Study groups in NCT06892548
Study groupRoleWhat they receive
Part 1 - BNT324 + BNT327 combination therapyExperimentalEscalating combination dose levels of BNT324 and BNT327 to define RP2D and RP2D-1 for NSCLC and SCLC.
Receives: Biological: BNT324; Biological: BNT327
Part 2 - Cohort 1: RP2D of BNT324 + BNT327 and RP2D-1 of BNT324 + BNT327ExperimentalIn subpopulation 1 of NSCLC actionable oncogenic alteration (AGA) negative, first-line (1L)
Receives: Biological: BNT324; Biological: BNT327
Part 2 - Cohort 2: RP2D of BNT324 + BNT327 and RP2D-1 of BNT324 + BNT327ExperimentalIn SCLC, second-line plus (2L+)
Receives: Biological: BNT324; Biological: BNT327
Part 2 - Cohort 3: RP2D of BNT324 + BNT327ExperimentalIn subpopulation 1 of NSCLC AGA negative, 2L+
Receives: Biological: BNT324; Biological: BNT327
Part 2 - Cohort 4: RP2D of BNT324 + BNT327ExperimentalIn subpopulation 2 of NSCLC AGA negative, 1L
Receives: Biological: BNT324; Biological: BNT327
Part 2 - Cohort 5: RP2D of BNT324 + BNT327ExperimentalIn subpopulation 2 of NSCLC AGA negative, 2L+
Receives: Biological: BNT324; Biological: BNT327
Part 2 - Cohort 6: RP2D of BNT324 + BNT327ExperimentalIn NSCLC AGA positive
Receives: Biological: BNT324; Biological: BNT327
Part 2 - Cohort 7: RP2D of BNT324 + BNT327ExperimentalIn SCLC, 1L
Receives: Biological: BNT324; Biological: BNT327

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1 - Occurrence of dose limiting toxicities (DLTs) by dose level

    Measured: During the DLT evaluation period, i.e., the time of initiation of the first dose of investigational medicinal product (IMP) up to 21 days]

  2. Part 1 - Occurrence of Treatment-emergent adverse events (TEAEs), serious TEAEs, treatment-related TEAEs, and treatment-related serious TEAEs by dose level

    Measured: From the time of the first dose of IMP to 90 days after the last IMP dose or until new anticancer therapy is started, whichever occurs first

  3. Part 1 - Occurrence of dose interruption, reduction, and treatment discontinuations due to TEAEs by dose level

    Measured: From the time of the first dose of IMP to 90 days after the last dose of IMP or until new anticancer therapy is started, whichever occurs first

  4. Part 2 cohorts 1 and 2 - Occurrence of TEAEs, serious TEAEs, treatment-related TEAEs, and treatment-related serious TEAEs by cohort and treatment arm

    Measured: From the time of the first dose of IMP to 90 days after the last IMP dose or until new anticancer therapy is started, whichever occurs first

  5. Part 2 cohorts 1 and 2 - Occurrence of dose interruption, reduction, and treatment discontinuation due to TEAEs by cohort and treatment arm

    Measured: From the time of the first dose of IMP to 90 days after the last IMP dose or until new anticancer therapy is started, whichever occurs first

  6. Part 2 cohorts 1 and 2 - Objective response rate (ORR) by cohort and treatment arm

    ORR defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) is observed as best overall response (per response evaluation criteria in solid tumors [RECIST] version 1.1 based on the investigator's assessment).

    Measured: From the time of initiation of the first dose of IMP to end of study, i.e., up to 87 months

  7. Part 2 cohorts 3-7 - ORR by cohort

    ORR, defined as the proportion of participants in whom a confirmed CR or PR is observed as best overall response (per RECIST version 1.1 based on the investigator's assessment).

    Measured: From the time of initiation of the first dose of IMP to end of study, i.e., up to 87 months

Secondary outcomes (9)

  1. Part 1 - ORR by dose level

    ORR, defined as the proportion of participants in whom a confirmed CR or PR is observed as best overall response (per RECIST version 1.1 based on the investigator's assessment).

    Measured: From the time of initiation of the first dose of IMP to end of study, i.e., up to 87 months

  2. Part 1 - Disease control rate (DCR) by dose level

    DCR, defined as the proportion of participants with confirmed CR, PR, or stable disease (SD) as best overall response (per RECIST version 1.1 based on the investigator's assessment).

    Measured: From the time of initiation of the first dose of IMP to end of study, i.e., up to 87 months

  3. Part 2 all cohorts - (PFS) by cohort and treatment arm

    PFS defined as the time from first dose of IMP to the first objective tumor progression (PD) or death from any cause, whichever occurs first, per RECIST version 1.1 based on the investigator's assessment.

    Measured: From the time of initiation of the first dose of IMP to end of study, i.e., up to 87 months

  4. Part 2 all cohorts - Duration of response (DOR) by cohort and treatment arm

    DOR, defined as the time from first objective response (CR or PR) to first occurrence of objective tumor progression (PD) or death from any cause, whichever occurs first (per RECIST version 1.1 based on the investigator's assessment).

    Measured: From the time of initiation of the first dose of IMP to end of study, i.e., up to 87 months

  5. Part 2 all cohorts - Overall survival (OS) by cohort and treatment arm

    OS, defined as the time from first dose of IMP to death from any cause.

    Measured: From the time of initiation of the first dose of IMP to end of study, i.e., up to 87 months

  6. Part 2 all cohorts - DCR by cohort and treatment arm

    DCR, defined as the proportion of participants with confirmed CR, PR, or SD as best overall response (per RECIST version 1.1 based on the investigator's assessment).

    Measured: From the time of initiation of the first dose of IMP to end of study, i.e., up to 87 months

  7. Part 2 all cohorts - Time to response (TTR) by cohort and treatment arm

    TTR, defined as the time from first dose of IMP to first objective response (CR or PR per RECIST version 1.1 based on the investigator's assessment).

    Measured: From the time of initiation of the first dose of IMP to end of study, i.e., up to 87 months

  8. Part 2 cohorts 3-7 - Occurrence of TEAEs, serious TEAEs, treatment-related TEAEs, and treatment-related serious TEAEs by cohort and treatment arm

    Measured: From the time of the first dose of IMPs to 90 days after the last IMP dose or until new anticancer therapy is started, whichever occurs first

  9. Part 2 cohorts 3-7 - Occurrence of dose interruption, reduction, and treatment discontinuation due to TEAEs by cohort and treatment arm

    Measured: From the time of the first dose of IMP to 90 days after the last IMP dose or until new anticancer therapy is started, whichever occurs first

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2025
  2. Study start2 May 2025
  3. Primary completionSep 2028 (estimated)
  4. Study completionMay 2032 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
594 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06892548
Sponsor's protocol ID
BNT324-01
Other IDs
2024-520238-31-00
Status last verified
Aug 2026
First submitted
19 Mar 2025
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BNT324 and BNT327 in people with Advanced Lung Cancer, run by BioNTech SE at 91 sites in 10 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 13 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in China, United States, Spain, Turkey (Türkiye), United Kingdom and 5 more countries. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact BioNTech clinical trials patient information (+49 6131 9084 ext. 0, patients@biontech.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1 - Occurrence of dose limiting toxicities (DLTs) by dose level (time frame: During the DLT evaluation period, i.e., the time of initiation of the first dose of investigational medicinal product (IMP) up to 21 days]). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06892548.

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 26 Aug 2026.

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