About this trial
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.
Eligibility criteria
Qualifiers
Have histologically or cytologically confirmed advanced tumors, who have failed standard therapy, or for whom no standard treatment option is available, or for whom standard therapy is not appropriate.
Have at least one measurable lesion based on RECIST 1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system [CNS] metastasis should not be considered as a measurable lesion).
Adequate hematologic and organ function.
Disqualifiers
Any prior treatment which inhibits cluster of differentiation 39 (CD39).
Vaccination with live attenuated vaccine(s) within 4 weeks prior to the first dose of IMP.
Any investigational product within 4 weeks or 5 half lives (if the half life of the other investigational product is known), whichever is longer, before the first dose of IMP in this study or ongoing participation in the active treatment phase of another interventional clinical study.
Systemic cytotoxic chemotherapy, immunotherapy within 3 weeks or five half-lives of the chemotherapy (whichever is shorter) prior to the first dose of IMP.
Trial design
Treatments tested in this trial
- BNT317 DL1
- BNT317 DL2
- BNT317 DL3
- BNT317 DL4
- BNT317 DL5 (intermediate)
- BNT317 DL6 (intermediate)
- BNT317 DL7 (additional)
Treatment groups
7
Treatment groupsSee each treatment group below.