RECRUITING

A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will evaluate the safety, efficacy, optimal dose, and pharmacokinetics (PK) of BNT326 as monotherapy (Part 1) and as combination treatment with immunotherapeutic agents (Part 2) in participants with histologically or cytologically confirmed solid tumors that are advanced (i.e., either metastatic or recurrent tumors with no further definitive treatment possible) and/or have relapsed/progressed after prior therapy.

Official Title

A Phase I/II, Open-label, Adaptive Two-part Trial to Evaluate the Safety, Efficacy, Optimal Dose and Pharmacokinetics of BNT326 as Monotherapy and in Combination With Cancer Immunotherapies in Participants With Advanced Solid Tumors

Quick Facts

Study Start:2025-08-12
Study Completion:2030-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07070232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

BioNTech clinical trials patient information
CONTACT
+49 6131 9084
patients@biontech.de

Principal Investigator

BioNTech Responsible Person
STUDY_DIRECTOR
BioNTech SE

Study Locations (Sites)

START Midwest, LLC
Grand Rapids, Michigan, 49546
United States
South Texas Accelerated Research Therapeutics (START), LLC
San Antonio, Texas, 78229
United States
START Mountain Region
West Valley City, Utah, 84119
United States

Collaborators and Investigators

Sponsor: BioNTech SE

  • BioNTech Responsible Person, STUDY_DIRECTOR, BioNTech SE

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-12
Study Completion Date2030-02

Study Record Updates

Study Start Date2025-08-12
Study Completion Date2030-02

Terms related to this study

Keywords Provided by Researchers

  • Combination with other investigational agents
  • Programmed death-ligand 1 (PD-L1)
  • Antibody-drug conjugate (ADC)
  • Human epidermal growth factor receptor 3 (HER3)
  • Programmed Death-1 (PD-1)
  • Programmed Death-1 monoclonal antibodies
  • Combination chemotherapy
  • Anti vascular endothelial growth factor-A (anti-VEGF-A)
  • Bispecific antibody
  • Immunotherapy
  • Dose optimization
  • Time to progression
  • Vascular endothelial growth factor (VEGF)
  • Cutaneous Melanoma
  • Rare melanoma
  • Actionable oncogenic alterations (AGA)-negative non-small cell lung cancer (NSCLC)
  • Epithelial growth factor receptor mutated (EGFRm) NSCLC

Additional Relevant MeSH Terms

  • Advanced Solid Tumor