Early-phase Trial to Assess the Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors

NCT07455734 | Recruiting Phase 1

• 1 other identifier: BNT3214-01
• Study Type: interventional
• Target: 533
• Locations: 4 countries
• Sites: 16

Brief Summary

This study is the first time the drug BNT3214 (also referred to as PM8102) will be tested in people. It is designed to find out if the drug is safe and how well it works for adults with advanced solid tumors. The study will have three parts. The first two parts (Parts A and B) will focus on testing different amounts of BNT3214 to figure out the best and safest dose. The third part (Part C) will test selected doses of BNT3214 in multiple types of cancer.

Conditions

Advanced Solid Tumor Cancer

Keywords

Advanced solid tumors; Bispecific antibody; Immune checkpoint inhibitor

Outcome Measures

Primary Outcomes (4)

• All parts - Number and percentage of participants with treatment emergent adverse events (TEAEs)

  Per DL/cohort. By United States National Cancer Institute Common Terminology Criteria for Adverse Events grading, seriousness, and relatedness.

  From the time of initiation of the first dose of BNT3214 until 90 days after the last dose of BNT3214

• All parts - Number and percentage of participants with dose interruptions, reductions, and discontinuation of BNT3214 due to TEAEs

  Per DL/cohort.

  Up to 24 months

• Parts A and B only - Number and percentage of participants with dose limiting toxicities (DLTs)

  During the DLT evaluation period

  From first dose up to 28 days

• Part C only - Objective response rate (ORR)

  Per DL/cohort. Defined as the percentage of participants in whom a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 (based on the investigator's assessment) is observed as best overall response.

  Up to 30 months

Secondary Outcomes (9)

• All parts - PK assessment: Area under the curve (AUC)

  Up to 3 months from first dose of BNT3214

• All parts - PK assessment: Maximum concentration (Cmax)

  Up to 3 months from first dose of BNT3214

• All parts - PK assessment: Time to maximum observed concentration (Tmax)

  Up to 3 months from first dose of BNT3214

• All parts - PK assessment: Half-life (t1/2)

  Up to 3 months from first dose of BNT3214

• Parts A and B only - ORR

  Up to 30 months

Study Arms (4)

Part A - Escalating DLs of BNT3214

EXPERIMENTAL

Up to 7 DLs of BNT3214. In Part A, participants will stay on the same DL. In DL1 and DL2, intra-participant dose escalation will be allowed at the discretion of the investigator as specified in the protocol.

Drug: BNT3214

Part B (optional) - Selected DLs of BNT3214

EXPERIMENTAL

Up to 4 DLs. The starting dose for Part B will be at least one DL below the DL that has been declared safe for Part A.

Drug: BNT3214

Part C - Optimized DL of BNT3214

EXPERIMENTAL

Optimized dose of BNT3214 selected based on totality of data from Parts A and (if conducted) Part B.

Drug: BNT3214

Part C - Dose expansion of BNT3214

EXPERIMENTAL

DLs as recommended based on the totality of available data from previous parts.

Drug: BNT3214

Interventions

BNT3214 DRUG

Intravenous infusion

Also known as: PM8102

Part A - Escalating DLs of BNT3214; Part B (optional) - Selected DLs of BNT3214; Part C - Dose expansion of BNT3214; Part C - Optimized DL of BNT3214

Eligibility Criteria

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

You may qualify if:

• Participants aged ≥18 years of age inclusive at the time of giving informed consent.
• Have at least one measurable tumor lesion based on RECIST v1.1. One lesion with prior local treatment (i.e., radiotherapy) can be considered measurable only if a disease progression from prior local treatment was demonstrated in the lesion per RECIST v1.1.
• Eastern Cooperative Oncology Group performance status of 0 or 1.
• Have a predicted life expectancy ≥3 months.
• Have histologically or cytologically confirmed locally advanced, recurrent, or metastatic solid tumors that 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 a clinical study of an investigational agent is a recognized standard of care.
• Have adequate liver function as defined in the protocol.
• Have adequate renal function as defined in the protocol.
• Have adequate hematologic function as defined in the protocol.
• Have adequate coagulation as defined in the protocol.

You may not qualify if:

• Untreated or symptomatic central nervous system (CNS) metastases and leptomeningeal disease.
• Have a primary CNS malignancy.
• Have active, or a history of, pneumonitis requiring treatment with steroids, or have active, or a history of, interstitial lung disease.
• 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.
• Have a history of significant hematologic toxicity to prior lines of therapy, as assessed by the investigator.
• Have uncontrolled hypertension or poorly controlled diabetes prior to allocation or randomization.
• Have concurrent malignancy within 5 years prior to allocation or randomization (protocol defined exceptions apply).
• Have unstable thrombotic event (e.g., deep vein thrombosis, arterial thrombosis, pulmonary embolism) requiring therapeutic intervention within 3 months prior to allocation or randomization, unless the participant has been fully treated (e.g., inferior vena cava filter placed) and/or adequately anticoagulated on a prophylactic dose.
• Have known human immunodeficiency virus infection or known acquired immunodeficiency syndrome (protocol defined exceptions apply).
• Have an active hepatitis B virus infection.
• 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 adverse reactions from prior anti-tumor therapy that have not returned to Grade ≤1, except for alopecia or toxicities (not specified elsewhere) considered irreversible and posing no safety risk to participants.
• Have active, or history of, autoimmune disease (e.g., myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, psoriatic arthritis, vasculitis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis) (protocol defined exceptions apply).
• Have serious non-healing wounds, ulcer, or bone fracture.

Sponsors & Collaborators

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

Study Sites (16)

Monash Medical Centre Clayton

Clayton, 3168, Australia

RECRUITING

Austin Health

Heidelberg Heights, 3081, Australia

NOT YET RECRUITING

Peter MacCallum Cancer Centre

Melbourne, 3000, Australia

NOT YET RECRUITING

Scientia Clinical Research Ltd

Randwick, 2031, Australia

NOT YET RECRUITING

Epworth HealthCare

Richmond, 3121, Australia

RECRUITING

Chongqing University Cancer Hospital

Chongqing, 400030, China

NOT YET RECRUITING

Nanfang Hospital of Southern Medical University

Guangzhou, 510515, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, 310022, China

NOT YET RECRUITING

Shanghai East Hospital

Shanghai, 200120, China

RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjin, 300060, China

NOT YET RECRUITING

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

NOT YET RECRUITING

Seoul National University Hospital

Seoul, 3080, South Korea

NOT YET RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, 3722, South Korea

NOT YET RECRUITING

Asan Medical Center

Seoul, 5505, South Korea

NOT YET RECRUITING

China Medical University Hospital

Taichung, 404332, Taiwan

NOT YET RECRUITING

National Taiwan University Hospital

Taipei, 100225, Taiwan

NOT YET RECRUITING

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 6, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2030
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5); KR (4); CN (5); TW (2)