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

ClinicalTrials.gov ID: NCT07070232

Public ClinicalTrials.gov record NCT07070232. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 3, 2026, 7:48 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT07070232
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: BioNTech SE; Industry
Enrollment: 1,438 participants

Conditions and interventions

Conditions

Advanced Solid Tumor

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 11, 2025
Primary completion: Feb 29, 2028
Completion: Feb 28, 2030
Last update posted: Sep 1, 2026

2025 – 2030

United States locations

U.S. sites: 19
U.S. states: 14
U.S. cities: 18

Facility	City	State	ZIP	Site status
Mayo Clinic Arizona	Phoenix	Arizona	85054	Not yet recruiting
University of California San Francisco	San Francisco	California	94158	Not yet recruiting
Hartford Healthcare	Hartford	Connecticut	06102	Recruiting
Yale University	New Haven	Connecticut	06511	Recruiting
Florida Cancer Specialists	Sarasota	Florida	34232	Recruiting
Moffitt Cancer Center	Tampa	Florida	33612-9497	Recruiting
Emory University	Atlanta	Georgia	30322	Not yet recruiting
Dana Farber Cancer Institute	Boston	Massachusetts	02215	Not yet recruiting
Massachusetts General Hospital	Boston	Massachusetts	02215	Recruiting
Brigitte Harris Cancer Pavilion BHCP	Detroit	Michigan	48202	Recruiting
START Midwest, LLC	Grand Rapids	Michigan	49546	Recruiting
Memorial Sloan Kettering Hospital	New York	New York	10065	Recruiting
Duke Cancer Institute	Durham	North Carolina	27710	Not yet recruiting
Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	44195	Recruiting
University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	15232	Recruiting
The University of Texas MD Anderson Cancer Center	Houston	Texas	77030	Recruiting
South Texas Accelerated Research Therapeutics (START), LLC	San Antonio	Texas	78229	Recruiting
START Mountain Region	West Valley City	Utah	84119	Recruiting
The Board of Regents of the University of Wisconsin	Madison	Wisconsin	53792-6188	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 57 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07070232, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 1, 2026 · Synced Sep 3, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07070232 live on ClinicalTrials.gov.

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