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Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT411 | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

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

Phase 1/2a, First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BNT411 as a Monotherapy in Patients With Solid Tumors and in Combination With Atezolizumab, Carboplatin and Etoposide in Patients With Chemotherapy-naïve Extensive-stage Small Cell Lung Cancer (ES-SCLC)

NCT04101357•BioNTech SE

View on ClinicalTrials.gov

Summary

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.

Detailed Description

The first part (Part 1A) of this trial was a FIH, open-label, dose-escalation trial studying BNT411 monotherapy in patients with different types of malignant solid tumors in order to determine the safety profile of BNT411. The second part (Part 1B) aimed to determine further the safety profile of BNT411 in combination with atezolizumab, carboplatin and etoposide in patients with chemotherapy-naïve ES-SCLC. The third part (Part 2) was the expansion phase to explore BNT411 further as a monotherapy or in combination with atezolizumab, carboplatin and etoposide in select tumor indications. Different treatment schedules and other indications were planned to be explored in Part 2 of this trial, however, the sponsor decided not to continue with this part of this trial.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•For Part 1A:
•Histologically confirmed solid tumor (cytology was allowed for non-small cell lung cancer \[NSCLC\], small cell lung cancer \[SCLC\] and pancreatic cancer) that was metastatic or unresectable and for which there was no available standard therapy likely to confer clinical benefit, or patients who were not candidates for such available therapy.
•For Part 1B:
•Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \[VALG\] staging system) who received no prior chemotherapy for extensive stage disease.
•Those treated with prior chemo/radiotherapy with curative intent for limited-stage small cell lung cancer (LS-SCLC) were treatment-free for at least 6 months since last chemo/radiotherapy.
•Did not have interstitial lung disease or active, non-infectious pneumonitis.
•For Both Part 1A and Part 1B:
•Male and female \>= 18 years of age.
•Must have signed an informed consent form (ICF) indicating that he or she understood the purpose of and procedures required for the trial and were willing to participate in the trial prior to any trial-related assessments or procedures.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
+48 more criteria

Exclusion Criteria

•Prior and Concomitant Therapy:
•Had received prior systemic therapy with a TLR7 agonist.
•Had been receiving: radiotherapy, chemotherapy, or molecularly-targeted agents or tyrosine kinase inhibitors within 2 weeks or 5 half-lives (whichever was longer) of the start of trial treatment; immunotherapy/monoclonal antibodies within 3 weeks of the start of trial treatment; any live vaccine within 4 weeks of the start of trial treatment; nitrosoureas, antibody-drug conjugates, or radioactive isotopes within 6 weeks of the start of trial treatment.
•Received concurrent systemic (oral or intravenous) steroid therapy \>10 mg prednisone daily or its equivalent for an underlying condition.
•Received concurrent strong inhibitors or inducers of the cytochrome P450 enzymes.
•Had major surgery within the 4 weeks before the first dose of BNT411.
•Had ongoing or active infection requiring intravenous treatment with anti-infective therapy that has been administered less than two weeks prior to first dose of trial treatment.
•Had side effects of any prior therapy or procedures for any medical condition not recovered to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.5 Grade \<= 1.
•* Notes: peripheral neuropathy Grade \<= 2 was allowed; alopecia of any grade was allowed.
•Medical Conditions

Locations (12)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Northwestern Medical Faculty Foundation

Chicago, Illinois, United States

Prisma Health-Upstate Cancer Institute

Greenville, South Carolina, United States

Universitaetsklinikum Koeln - (Recruiting only for part 1B and part 2)

Cologne, Germany

University Medical Center Hamburg-Eppendorf - (Recruiting only for part 1B and part 2)

Hamburg, Germany

Universitaetsmedizin der Johannes Gutenberg Universitat Mainz KoeR - (Recruiting only for part 1B and part 2)

Mainz, Germany

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Clinica Universidad de Navarra

Madrid, Spain

START Madrid - CIOCC. Grupo Hospital de Madrid (HM) - Centro Integral Oncologico Clara Campal (CIOCC)

Madrid, Spain

Hospital Universitario La Fe de Valencia

Valencia, Spain

Key Dates

Start Date

June 19, 2020

Primary Completion Date

January 19, 2024

Completion Date

May 23, 2024

Last Updated

March 18, 2025

Enrollment

ACTUAL participants

Conditions

Solid TumorExtensive-stage Small Cell Lung Cancer

Interventions

BNT411

DRUG

Atezolizumab

DRUG

Carboplatin

DRUG

Etoposide

DRUG

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RECRUITINGPHASE1/PHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of PYX-201 in Advanced Solid Tumors

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