Actively Recruiting
Early-phase Trial to Assess the Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors
Led by BioNTech SE · Updated on 2026-05-14
533
Participants Needed
5
Research Sites
235 weeks
Total Duration
On this page
Sponsors
B
BioNTech SE
Lead Sponsor
B
BioNTech (Shanghai) Pharmaceuticals Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Early-phase Trial to Assess the Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 218 years or older at the time of consent
- Have at least one measurable tumor lesion based on RECIST v1.1
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Predicted life expectancy of at least 3 months
- Histologically or cytologically confirmed locally advanced, recurrent, or metastatic solid tumors that progressed after at least one standard therapy, or standard therapy is unsuitable
- Adequate liver function as defined in the protocol
- Adequate renal function as defined in the protocol
- Adequate hematologic function as defined in the protocol
- Adequate coagulation as defined in the protocol
You will not qualify if you...
- Untreated or symptomatic central nervous system metastases or leptomeningeal disease
- Primary central nervous system malignancy
- Active or history of pneumonitis requiring steroids or interstitial lung disease
- Significant lung problems including chronic obstructive pulmonary disease or restrictive lung disease
- History of severe cardiovascular disease
- History of significant blood toxicity from prior therapies
- Uncontrolled high blood pressure or poorly controlled diabetes before enrollment
- Another cancer within 5 years prior to enrollment (with some exceptions)
- Unstable blood clotting events requiring treatment within 3 months before enrollment unless treated and anticoagulated
- Known HIV infection or AIDS (with exceptions)
- Active hepatitis B virus infection
- Active hepatitis C virus infection unless cleared or treated
- Unresolved side effects from previous anti-tumor therapy except hair loss or non-safety risks
- Active or history of autoimmune diseases (with exceptions)
- Serious non-healing wounds, ulcers, or bone fractures
- Lung cancer patients with major coagulation disorders or bleeding risk
- History of severe immune-related side effects leading to stopping prior immunotherapy
- Small bowel obstruction requiring hospitalization within 3 months before enrollment
- Use of immunosuppressive medications within 14 days before first dose (with exceptions)
- Use of systemic corticosteroids above 10 mg prednisone daily within 10 days before study
- Vaccination with live vaccines within 4 weeks before starting study treatment
- Other protocol defined criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Monash Medical Centre Clayton
Fitzroy, Australia, 3065
Not Yet Recruiting
2
Epworth HealthCare
Richmond, Australia, 3121
Not Yet Recruiting
3
Nanfang Hospital of Southern Medical University
Guangzhou, China, 510515
Actively Recruiting
4
Shanghai East Hospital
Shanghai, China, 200120
Actively Recruiting
5
National Taiwan University Hospital
Taipei, Taiwan, 100225
Not Yet Recruiting
Research Team
B
BioNTech clinical trials patient information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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