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

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.

Trial Details

NCT ID
NCT07070232
Phase
PHASE1 / PHASE2
Sponsor
BioNTech SE
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • BNT326
  • Pumitamig
  • Itraconazole
  • Paroxetine
Locations (sample)
  • San Francisco, California, United States|37.77493,-122.41942
  • Hartford, Connecticut, United States|41.76371,-72.68509
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Sarasota, Florida, United States|27.33643,-82.53065
  • Tampa, Florida, United States|27.94752,-82.45843

Key Eligibility Criteria

  • Aged ≥18 years at the time of giving informed consent. Local laws will be followed if the age of consent is older.
  • Have histologic or cytologic documented advanced disease, either at relapse or upon diagnosis of metastatic disease. This requirement may be consid…
  • Have measurable disease defined by RECIST v1.1.
  • All participants must provide a tumor tissue sample (Formalin-fixed paraffin-embedded \[FFPE\] slides) from archival tissue. The archival tissue ca…

For full eligibility, visit ClinicalTrials.gov.

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