Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBioNTech SE
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
BNT317 DL1
Biological/VaccineIntravenous infusion
BNT317 DL2
Biological/VaccineIntravenous infusion
BNT317 DL3
Biological/VaccineIntravenous infusion
BNT317 DL4
Biological/VaccineIntravenous infusion
BNT317 DL5 (intermediate)
Biological/VaccineIntravenous infusion
BNT317 DL6 (intermediate)
Biological/VaccineIntravenous infusion
BNT317 DL7 (additional)
Biological/VaccineIntravenous infusion
Treatment groups
39 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Group A: BNT317 DL1Experimental treatment 1 intervention
Group B: BNT317 DL2Experimental treatment 1 intervention
Group C: BNT317 DL3Experimental treatment 1 intervention
Group D: BNT317 DL4Experimental treatment 1 intervention
Group E: BNT317 DL5 (optional, intermediate)Experimental treatment 1 intervention
Group F: BNT317 DL6 (optional, intermediate)Experimental treatment 1 intervention
Group G: BNT317 DL7 (optional, additional)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Occurrence of DLTs
Per dose group. During the DLT observation period.
Time frame
up to 28 days post IMP administration on Day 1 of Cycle 1 or the day before Cycle 3 Day 1, whichever comes earlier (each cycle is 14 days)2
Occurrence of treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs)
Per dose group. Assessed according to (US National Cancer Institute) Common Terminology Criteria for Adverse Events version 5.0, including Grade ≥3, serious, fatal TEAE by relationship.
Time frame
from first IMP administration up to 100 days after last dose of IMP or until a new anticancer therapy is initiated3
Occurrence of dose interruption or discontinuation of study treatment due to TEAEs
Per dose group.
Time frame
from first IMP administration up to 14 days after the last dose of IMP4
MTD or the recommended phase two dose (RP2D) of BNT317
Time frame
For MTD, up to 28 days post IMP administration on Cycle 1 Day 1 or the day before Cycle 3 Day 1, whichever comes earlier (each cycle is 14 days) or, for RP2D, up to 100 daysSecondary outcomes
1
Objective Response Rate (ORR)
Per dose group. Defined as the proportion of participants in whom a complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\]) is observed as best overall response.
Time frame
from first IMP administration up to 100 days after last dose of IMP or until a new anticancer therapy is initiated2
Duration of Response (DOR)
Per dose group. Defined as the time from first objective response (CR or PR per RECIST v1.1) to first occurrence of objective tumor progression (progressive disease per RECIST v1.1) or death from any cause, whichever occurs first.
Time frame
from first IMP administration up to 100 days after last dose of IMP or until a new anticancer therapy is initiated3
Disease Control Rate (DCR)
Per dose group. Defined as the proportion of participants with confirmed CR or PR or stable disease (per RECIST v1.1) is observed as best overall response.
Time frame
from at least 6 weeks after the first IMP dose up to 100 days after last dose of IMP or until a new anticancer therapy is initiated4
PK assessment: The maximum (peak) serum concentration (Cmax) of BNT317
Per dose group. If data permits.
Time frame
from pre-dose Cycle 1 to pre-dose Cycle 4 (each cycle is 14 days)Sponsors and contacts
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Source ClinicalTrials.gov