Actively Recruiting
A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors
Led by BioNTech SE · Updated on 2026-04-06
375
Participants Needed
16
Research Sites
152 weeks
Total Duration
On this page
Sponsors
B
BioNTech SE
Lead Sponsor
B
Biotheus (Hengqin) Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The aim of this first-in-human (FIH) open-label, multi-site study is to evaluate safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary clinical efficacy of BNT3212, including identification of the recommended dose of BNT3212 for use as monotherapy and with pumitamig (also known as BNT327 or PM8002) as combination therapy, in adults with advanced solid tumors who have exhausted other treatment options.
CONDITIONS
Official Title
A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with locally advanced, recurrent, or metastatic solid tumors confirmed by tissue tests
- Received prior appropriate therapy for their tumor type or have no suitable standard therapy
- 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
- Left ventricular ejection fraction of 50% or higher within 28 days before treatment
- Adequate liver, kidney, blood, and clotting function
- Recovered to mild or baseline level from prior anti-cancer treatment side effects, except certain stable laboratory abnormalities or mild toxicities
- Medically acceptable to stop prior anti-cancer therapies with required washout periods
- For Parts B and D, diagnosis with specific tumor types as defined by the study
You will not qualify if you...
- Active infections requiring systemic treatment other than oral antibiotics
- Primary central nervous system cancers
- Untreated or symptomatic brain metastases needing corticosteroids or anticonvulsants
- Unstable fluid buildup in chest or abdomen requiring drainage within 14 days before treatment
- Active or history of pneumonitis or interstitial lung disease
- Significant lung complications
- History of severe heart disease
- Severe blood-related toxicities from prior treatments
- Active or chronic eye corneal disorders that prevent drug monitoring
- Uncontrolled high blood pressure or poorly controlled diabetes
- Another cancer within 5 years except certain skin cancers or carcinoma in situ after surgery
- Unstable blood clotting events
- Ongoing side effects from prior anti-cancer treatments above mild severity unless deemed safe
- For Parts C and D, prior treatment with PD-1/L1 and VEGF-A antibody combinations
- For Parts C and D, active or history of autoimmune disease or immune deficiency with certain exceptions
- For Parts C and D, serious non-healing wounds, ulcers, or bone fractures
- For Parts C and D, major blood clotting disorders or risks of bleeding
- For Parts C and D, history of severe immune-related side effects causing treatment stop
- For Parts C and D, small bowel obstruction requiring hospital stay within 3 months
- For Parts C and D, recent anticoagulant or antiplatelet therapy within specified days before 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: 16 locations
1
Cancer Research SA
Adelaide, Australia, 5000
Not Yet Recruiting
2
Monash Medical Centre
Clayton, Australia, 3168
Not Yet Recruiting
3
Peter MacCallum Cancer Centre
Melbourne, Australia, 3000
Not Yet Recruiting
4
The Alfred Hospital
Melbourne, Australia, 3004
Actively Recruiting
5
One Clinical Research
Nedlands, Australia, 6009
Not Yet Recruiting
6
Scientia Clinical Research Limited
Randwick, Australia, 2031
Actively Recruiting
7
Beijing Cancer Hospital
Beijing, China, 100142
Actively Recruiting
8
Anhui Provincial Hospital
Hefei, China, 230061
Actively Recruiting
9
First Affiliated Hospital of Xinxiang Medical University
Henan, China, 453003
Actively Recruiting
10
Hunan Province Cancer Hospital
Hunan, China, 410006
Not Yet Recruiting
11
Shandong University-Jinan Central Hospital
Shandong, China, 250013
Not Yet Recruiting
12
Linyi Tumor Hospital
Shandong, China, 276001
Actively Recruiting
13
Shanghai East Hospital
Shanghai, China, 200120
Actively Recruiting
14
Shanghai GoBroad Cancer Hospital
Shanghai, China, 200131
Actively Recruiting
15
Sichuan Cancer Hospital
Sichuan, China, 610041
Actively Recruiting
16
Zhejiang Cancer Hospital
Zhejiang, China, 310022
Actively Recruiting
Research Team
:
: BioNTech clinical trials patient information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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