Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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
NCT07070232 · View on ClinicalTrials.gov ↗
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
| Field | Value |
|---|---|
| Enrollment Target | 980 participants |
| Start Date | 2025-08-12 |
| Est. Completion | 2029-10 |
| Phase | Phase 1 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07070232
The ClinicalTrials.gov registry entry for NCT07070232 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 980 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioNTech SE, which has 123 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07070232 reports 20 study locations spanning 14 distinct geographic areas — top geographies include New South Wales, Connecticut, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07070232?
The interventions under investigation include: Pumitamig (DRUG), Itraconazole (DRUG), BNT326 (DRUG), Paroxetine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07070232?
This trial is sponsored by BioNTech SE, which has 123 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.