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Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors

ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBioNTech SE

About this trial

This is a first-in-human (FIH), open-label, multi-site study which will evaluate the safety, efficacy, tolerability, pharmacokinetics (PK), and immunogenicity of increasing doses of BNT317 in participants with advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

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 v1.1. 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, as defined in the protocol.

Have had an adequate treatment washout period before randomization/enrollment, as defined in the protocol.

Disqualifiers

Any prior treatment which inhibits cluster of differentiation 39.

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/Vaccine

    Intravenous infusion

  • BNT317 DL2

    Biological/Vaccine

    Intravenous infusion

  • BNT317 DL3

    Biological/Vaccine

    Intravenous infusion

  • BNT317 DL4

    Biological/Vaccine

    Intravenous infusion

  • BNT317 DL5

    Biological/Vaccine

    Intravenous infusion

  • BNT317 DL6

    Biological/Vaccine

    Intravenous infusion

  • BNT317 selected DLA

    Biological/Vaccine

    Intravenous infusion

  • BNT317 selected DLB

    Biological/Vaccine

    Intravenous infusion

  • SoC chemotherapy 1

    Drug

    Intravenous infusion

  • SoC chemotherapy 2

    Drug

    Intravenous infusion

Treatment groups

248 Participants
are divided into 11 treatment groups

11

Treatment groups

See each treatment group below.

Group A: Part A - BNT317 DL1Experimental treatment 1 intervention
Group B: Part A - BNT317 DL2Experimental treatment 1 intervention
Group C: Part A - BNT317 DL3Experimental treatment 1 intervention
Group D: Part A - BNT317 DL4Experimental treatment 1 intervention
Group E: Part A - BNT317 DL5Experimental treatment 1 intervention
Group F: Part A - BNT317 DL6 (optional)Experimental treatment 1 intervention
Group G: Part B1 - BNT317 selected DLAExperimental treatment 1 intervention
Group H: Part B1 - BNT317 selected DLBExperimental treatment 1 intervention
Group I: Part B2 - BNT317 selected DLA plus SoC chemotherapy 1Experimental treatment 2 interventions
Group J: Part B2 - BNT317 selected DLB plus SoC chemotherapy 1Experimental treatment 2 interventions
Group K: Part B3 - BNT317 selected DLB plus SoC chemotherapy 2Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Part A - Occurrence of DLTs

Per dose group. During the DLT observation period.

Time frame
Up to 28 days after initiating BNT317 administration on Day 1 of Cycle 1 or the day before Cycle 3 Day 1, whichever comes earlier (each cycle is 14 days)
2

All parts - Occurrence of treatment-emergent adverse events (TEAEs), Grade ≥3 TEAEs, serious adverse events (SAEs), treatment-related adverse events (TRAEs), treatment-related Grade ≥3 TEAEs, and treatment-related SAEs

Per dose group.

Time frame
From the first dose of BNT317 up to 100 days after last dose of IMP or until a new anticancer therapy is initiated
3

All parts - Occurrence of dose interruption, reductions, and discontinuation of BNT317 due to TEAEs

Per dose group.

Time frame
From the first dose of BNT317 up to 100 days after last dose of IMP or until a new anticancer therapy is initiated
4

Parts B1, B2 & B3: Objective Response Rate (ORR)

Per dose group. Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\] based on the investigator's assessment) is observed as best overall response.

Time frame
From the first dose of BNT317 up to 100 days after last dose of IMP or until a new anticancer therapy is initiated

Secondary outcomes

1

Part A - ORR

Per dose group. Defined as the proportion of participants in whom a confirmed CR or PR (per RECIST v1.1 based on the investigator's assessment) is observed as best overall response.

Time frame
From the first dose of BNT317 up to 100 days after last dose of IMP or until a new anticancer therapy is initiated
2

All parts - Duration of Response

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 the first dose of BNT317 up to 100 days after last dose of IMP or until a new anticancer therapy is initiated
3

All parts - Disease Control Rate

Per dose group. Defined as the proportion of participants in whom a confirmed CR or PR or stable disease (per RECIST v1.1) is observed as best overall response per investigator's assessment.

Time frame
From at least 6 weeks (±7 days) after the first BNT317 dose up to 100 days after last dose of IMP or until a new anticancer therapy is initiated
4

All Parts - 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)

Other outcomes

Sponsors and contacts

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BioNTech SE

Lead sponsor

Source ClinicalTrials.gov
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