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

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
BioNTech SE
Study ID
NCT06750185
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BNT317 DL1 — BIOLOGICAL
    Intravenous infusion
  • BNT317 DL2 — BIOLOGICAL
    Intravenous infusion
  • BNT317 DL3 — BIOLOGICAL
    Intravenous infusion
  • BNT317 DL4 — BIOLOGICAL
    Intravenous infusion
  • BNT317 DL5 (intermediate) — BIOLOGICAL
    Intravenous infusion
  • BNT317 DL6 (intermediate) — BIOLOGICAL
    Intravenous infusion
  • BNT317 DL7 (additional) — BIOLOGICAL
    Intravenous infusion

Study Details

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.

Key Dates

Start date
Jan 13, 2025
Status verified
Feb 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
39 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: BNT317 DL1
    BNT317 monotherapy
  • Experimental: BNT317 DL2
    BNT317 monotherapy
  • Experimental: BNT317 DL3
    BNT317 monotherapy
  • Experimental: BNT317 DL4
    BNT317 monotherapy
  • Experimental: BNT317 DL5 (optional, intermediate)
    BNT317 monotherapy
  • Experimental: BNT317 DL6 (optional, intermediate)
    BNT317 monotherapy
  • Experimental: BNT317 DL7 (optional, additional)
    BNT317 monotherapy

Primary Outcome Measure

Occurrence of DLTs [ 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) ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Norton Cancer Institute PARENTLouisvilleKentucky40202-
START MidwestGrand RapidsMichigan49546-
Carolina BioOncology Institute, LLCHuntersvilleNorth Carolina28078-
Rhode Island HospitalEast ProvidenceRhode Island02903-
MUSC Hollings Cancer CenterCharlestonSouth Carolina29425-
Mary Crowley Cancer ResearchDallasTexas75230-
South Texas Accelerated Research Therapeutics (START), LLCSan AntonioTexas78229-

Find similar trials in Louisville, KY

By research site
Norton Cancer Institute PARENT· Louisville, KYSTART Midwest· Grand Rapids, MICarolina BioOncology Institute, LLC· Huntersville, NCRhode Island Hospital· East Providence, RIMUSC Hollings Cancer Center· Charleston, SCMary Crowley Cancer Research· Dallas, TX

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