Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT411

Part of paid clinical trials in Los Angeles, California.

Sponsor
BioNTech SE
Study ID
NCT04101357
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Extensive-stage Small Cell Lung Cancer
  • Solid Tumor

Eligibility Criteria

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

Interventions

  • BNT411 — DRUG
    intravenous
  • Atezolizumab — DRUG
    intravenous
  • Carboplatin — DRUG
    intravenous
  • Etoposide — DRUG
    intravenous

Study Details

This first-in-human (FIH) trial aimed to establish a safe dose of BNT411 as a monotherapy and in combination with atezolizumab, carboplatin and etoposide. BNT411 is a toll-like receptor 7 (TLR7) agonist which is expected to mount broad innate and adaptive immune reactions, especially in combination with cytotoxic therapies and immune checkpoint inhibitors.

Key Dates

Start date
Jun 19, 2020
Status verified
Feb 2025
Primary completion
Jan 19, 2024
Completion
May 23, 2024

Study Design

Enrollment
54 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1A - monotherapy dose escalation
    BNT411 monotherapy
  • Experimental: Part 1B - combination dose escalation
    BNT411 in combination with atezolizumab, carboplatin, and etoposide.
  • Experimental: Part 2 - expansion cohorts
    BNT411 either as monotherapy or in combination with atezolizumab, carboplatin, and etoposide. Please note that the sponsor decided not to continue with this part of this trial.

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (21 Days) ]

Locations (3)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
Northwestern Medical Faculty FoundationChicagoIllinois60611-
Prisma Health-Upstate Cancer InstituteGreenvilleSouth Carolina29605-

Related coverage on Hipa.ai

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Medical Center· Los Angeles, CANorthwestern Medical Faculty Foundation· Chicago, ILPrisma Health-Upstate Cancer Institute· Greenville, SC

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