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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: Recruiting Phase 1 study of Advanced Solid Tumor, sponsored by BioNTech SE.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
By cohort and by dose in (Part 1), and by cohort and combination treatment regimen (in Part 2).
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 |
What NCT07070232 shows while recruiting
NCT07070232 is an interventional study that assigns participants to a tested intervention. The registered 980 participants enrollment target is mid-sized for trials with a published cap, above the 188-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (421% higher).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07070232's enrollment target sits among peer trials
980 4th of 189 higher than 186 of 189 other Advanced Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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