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NCT07070232 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Advanced Solid Tumor, sponsored by BioNTech SE.

Recruiting
Registry status
Phase 1
Development phase
980
Enrollment target
20
Study locations

NCT07070232 is a Phase 1 study of Advanced Solid Tumor that is actively recruiting participants, run by BioNTech SE. The registered enrollment target is 980 participants, above the 188-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (421% higher). The trial reports 20 study locations across 14 states.

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The verdict

NCT07070232, a Phase 1 study of Advanced Solid Tumor, is actively recruiting participants, sponsored by BioNTech SE.

RECRUITING
Registry status
Phase 1
Development phase
980 participants
Enrollment target
20
Study locations

Study Summary

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.

Conditions Studied

Interventions

  • DRUG Pumitamig
  • DRUG Itraconazole
  • DRUG BNT326
  • DRUG Paroxetine

Study Locations (20)

New South Wales

  • Blacktown Hospital - Blacktown
  • St Vincent's Hospital Sydney - Darlinghurst
  • Melanoma Institute Australia - Wollstonecraft

Connecticut

  • Hartford Healthcare - Hartford
  • Yale University - New Haven

Florida

  • Florida Cancer Specialists - Sarasota
  • Moffitt Cancer Center - Tampa

Massachusetts

  • Dana Farber Cancer Institute - Boston
  • Massachusetts General Hospital - Boston

Texas

  • The University of Texas MD Anderson Cancer Center - Houston
  • South Texas Accelerated Research Therapeutics (START), LLC - San Antonio

California

  • University of California San Francisco - San Francisco

Michigan

  • START Midwest, LLC - Grand Rapids

New York

  • Memorial Sloan Kettering Hospital - New York

Trial Details

FieldValue
Enrollment Target 980 participants
Start Date 2025-08-12
Est. Completion 2029-10
Phase Phase 1

Sponsor

BioNTech SE

53 total trials

What the Registry Record Tells You About NCT07070232

The ClinicalTrials.gov registry entry for NCT07070232 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 980 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 188-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (421% higher). The listed sponsor is BioNTech SE, which has 53 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Advanced Solid Tumor appearing as the primary indexed condition, and to 4 interventions - of which Pumitamig is the first listed.

NCT07070232 reports 20 study locations spanning 14 distinct geographic areas - top geographies include New South Wales, Connecticut, Florida.

Frequently Asked Questions

What is clinical trial NCT07070232 about?

NCT07070232 is a clinical study titled "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 met...

What is the current status of trial NCT07070232?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 980 participants. The study started on 2025-08-12. Estimated completion is 2029-10.

What conditions does trial NCT07070232 study?

This clinical trial studies the following conditions: Advanced Solid Tumor.

What interventions are being tested in trial NCT07070232?

The interventions under investigation include: Pumitamig (DRUG), Itraconazole (DRUG), BNT326 (DRUG), Paroxetine (DRUG).

Who is sponsoring clinical trial NCT07070232?

This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07070232 being conducted?

This trial has 20 study locations across California, Connecticut, Florida, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.