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/PHASE2
Status
Recruiting
Apply to this trial

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 — BIOLOGICAL
    Intravenous infusion
  • BNT317 DL6 — BIOLOGICAL
    Intravenous infusion
  • BNT317 selected DLA — BIOLOGICAL
    Intravenous infusion
  • BNT317 selected DLB — BIOLOGICAL
    Intravenous infusion
  • SoC chemotherapy 1 — DRUG
    Intravenous infusion
  • SoC chemotherapy 2 — DRUG
    Intravenous infusion

Study Details

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.

Key Dates

First listed
Dec 27, 2024
Start date
Jan 13, 2025
Status verified
Sep 2026
Primary completion
Apr 30, 2031
Completion
Apr 30, 2031

Study Design

Enrollment
248 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A - BNT317 DL1
    BNT317 monotherapy
  • Experimental: Part A - BNT317 DL2
    BNT317 monotherapy
  • Experimental: Part A - BNT317 DL3
    BNT317 monotherapy
  • Experimental: Part A - BNT317 DL4
    BNT317 monotherapy
  • Experimental: Part A - BNT317 DL5
    BNT317 monotherapy
  • Experimental: Part A - BNT317 DL6 (optional)
    BNT317 monotherapy
  • Experimental: Part B1 - BNT317 selected DLA
    BNT317 monotherapy, DL as selected from Part A.
  • Experimental: Part B1 - BNT317 selected DLB
    BNT317 monotherapy, DL as selected from Part A.
  • Experimental: Part B2 - BNT317 selected DLA plus SoC chemotherapy 1
    BNT317 combination therapy, DL as selected from Part A.
  • Experimental: Part B2 - BNT317 selected DLB plus SoC chemotherapy 1
    BNT317 combination therapy, DL as selected from Part A.
  • Experimental: Part B3 - BNT317 selected DLB plus SoC chemotherapy 2
    BNT317 combination therapy, DL as selected from Parts B1 and B2.

Primary Outcome Measure

Part A - Occurrence of DLTs [ 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) ]

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

Related Studies