A Phase I, First-in-human, Open-label, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BNT317 in Patients With Advanced Solid Tumors
BioNTech SE
Summary
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.
Description
Participants will be assigned to one of four dose levels of BNT317. One treatment cycle contains one treatment. Participants may receive investigational medicinal product (IMP) for up to 2 years or until they experience disease progression, unacceptable toxicities, withdrawal of consent, study discontinuation or investigator decision. The total duration of the study for a singe participant may be up to 2 years, plus follow-up until the last participant has completed 1 year of survival follow-up (excluding screening). In the dose escalation phase, an accelerated titration design for Dose Leve…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * 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 bon…
Interventions
- BiologicalBNT317 DL1
Intravenous infusion
- BiologicalBNT317 DL2
Intravenous infusion
- BiologicalBNT317 DL3
Intravenous infusion
- BiologicalBNT317 DL4
Intravenous infusion
- BiologicalBNT317 DL5 (intermediate)
Intravenous infusion
- BiologicalBNT317 DL6 (intermediate)
Intravenous infusion
- BiologicalBNT317 DL7 (additional)
Intravenous infusion
Locations (11)
- Norton Cancer Institute PARENTLouisville, Kentucky
- START MidwestGrand Rapids, Michigan
- Carolina BioOncology Institute, LLCHuntersville, North Carolina
- Rhode Island HospitalEast Providence, Rhode Island
- MUSC Hollings Cancer CenterCharleston, South Carolina
- Mary Crowley Cancer ResearchDallas, Texas