Actively Recruiting
Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors
Led by BioNTech SE · Updated on 2026-02-11
39
Participants Needed
11
Research Sites
176 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a first-in-human (FIH), open-label, multiple-site, dose escalation study which will evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of increasing doses of BNT317 in participants with advanced solid tumors.
CONDITIONS
Official Title
Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed advanced tumors with no effective standard therapy available or standard therapy not appropriate
- At least one measurable lesion based on RECIST 1.1 criteria
- Adequate blood counts and organ function
You will not qualify if you...
- Prior treatment with any agent inhibiting cluster of differentiation 39 (CD39)
- Vaccination with live attenuated vaccines within 4 weeks before first dose
- Participation in another investigational study or use of investigational product within 4 weeks or 5 half-lives before first dose
- Systemic chemotherapy or immunotherapy within 3 weeks or five half-lives prior to first dose
- Radiation therapy to chest, brain, or internal organs within 4 weeks prior to first dose
- Palliative radiotherapy to metastases within 2 weeks prior to first dose
- Systemic corticosteroids over 10 mg/day prednisone or equivalent within 2 weeks prior to first dose (short-term or local corticosteroids allowed)
- Untreated symptomatic or large brain metastases
- Neurologically unstable treated brain metastases or on steroids/anticonvulsants within 2 weeks before study
- Brain metastases not stable 4 weeks after radiotherapy
- Known leptomeningeal metastases
- Uncontrolled hypertension or poorly controlled diabetes
- History of allogeneic stem cell or organ transplantation
- History of serious Grade 3 or higher immune-related adverse events leading to immunotherapy discontinuation
- Uncontrolled pleural, pericardial effusion, or ascites needing frequent drainage
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Norton Cancer Institute PARENT
Louisville, Kentucky, United States, 40202
Actively Recruiting
2
START Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
3
Carolina BioOncology Institute, LLC
Huntersville, North Carolina, United States, 28078
Actively Recruiting
4
Rhode Island Hospital
East Providence, Rhode Island, United States, 02903
Actively Recruiting
5
MUSC Hollings Cancer Center
Charleston, South Carolina, United States, 29425
Actively Recruiting
6
Mary Crowley Cancer Research
Dallas, Texas, United States, 75230
Actively Recruiting
7
South Texas Accelerated Research Therapeutics (START), LLC
San Antonio, Texas, United States, 78229
Actively Recruiting
8
Tasman Oncology Research Ltd
Southport, Queensland, Australia, 4215
Actively Recruiting
9
Cancer Research SA
Adelaide, Australia, 5000
Actively Recruiting
10
Monash Medical Centre Clayton
Clayton, Australia, 3168
Actively Recruiting
11
Scientia Clinical Research
Randwick, Australia, 2031
Actively Recruiting
Research Team
B
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
7
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