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
Condition(s) studied
Investigational drug(s) / intervention(s)
BNT326: Intravenous (IV) infusion
Pumitamig: IV infusion
Itraconazole: Oral administration
Paroxetine: Oral administration
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.
Eligibility
Primary outcome measure(s)
- Parts 1 and 2 - All cohorts except Cohort 1F - Occurrence of treatment emergent adverse events (TEAEs), treatment related adverse events (TRAEs), treatment emergent serious adverse events (TESAEs), and treatment related serious adverse events (TRSAEs) — from first dose of investigational medicinal product (IMP) up to 42 days (Part 1) and 90 days (Part 2) after the last dose of IMP or until a new systemic anti-cancer therapy is started, whichever occurs first (up to 26 months Part 1 or 27 months Part 2)
By cohort and by dose in (Part 1), and by cohort and combination treatment regimen (in Part 2). - Parts 1 and 2 - All cohorts except Cohort 1F - Occurrence of dose interruption, reduction, and treatment discontinuations due to TEAEs — from first dose of IMP up to 42 days (Part 1) and 90 days (Part 2) after the last dose of IMP or until a new systemic anti-cancer therapy is started, whichever occurs first (up to 26 months Part 1 or 27 months Part 2)
By cohort and by dose in (Part 1), and by cohort and combination treatment regimen (in Part 2) - Parts 1 and 2 - All cohorts except Cohort 1F - Confirmed overall response rate (ORR) — from the time of initiation of the first dose of IMP up to approximately 38 months (Part 1) and approximately 48 months (Part 2)
Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) based on the investigator's assessment (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\]) is observed as best overall response. By cohort and by dose in (Part 1), and by cohort and combination treatment regimen (in Part 2). - Part 2 - Occurrence of dose limiting toxicities (DLTs) — from the time of initiation of the first dose of IMP up to 21 days
During the DLT observation period. - Part 1 - Cohort 1F (DDI) only - PK assessment: Maximum concentration (Cmax) derived from serum concentrations of BNT326 ADC and unconjugated payload — from the time of initiation of the first dose of IMP up to safety follow-up visit, approximately 42 days post last IMP dose
Evaluation of Cmax without and in combination with the CYP inhibitors (± itraconazole or ± paroxetine). Treatment comparison using geometric mean ratio of Cycle 3 as compared with Cycle 2 as a reference. - Part 1 - Cohort 1F (DDI) only - PK assessment: Area under the curve (AUC) over the last 17-day dosing interval derived from serum concentrations of BNT326 ADC and unconjugated payload — from the time of initiation of the first dose of IMP up to safety follow-up visit, approximately 42 days post last IMP dose
Evaluation of AUC over the last 17-day dosing interval without and in combination with the CYP inhibitors (± itraconazole or ± paroxetine). Treatment comparison using geometric mean ratio of Cycle 3 as compared with Cycle 2 as a reference.
Trial sites (77)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | Not Yet Recruiting |
| University of California San Francisco | San Francisco | California | Not Yet Recruiting |
| Hartford Healthcare | Hartford | Connecticut | Recruiting |
| Yale University | New Haven | Connecticut | Recruiting |
| Florida Cancer Specialists | Sarasota | Florida | Recruiting |
| Moffitt Cancer Center | Tampa | Florida | Recruiting |
| Emory University | Atlanta | Georgia | Not Yet Recruiting |
| Dana Farber Cancer Institute | Boston | Massachusetts | Not Yet Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Recruiting |
| Brigitte Harris Cancer Pavilion BHCP | Detroit | Michigan | Recruiting |
| START Midwest, LLC | Grand Rapids | Michigan | Recruiting |
| Memorial Sloan Kettering Hospital | New York | New York | Recruiting |
| Duke Cancer Institute | Durham | North Carolina | Not Yet Recruiting |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | Recruiting |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | Recruiting |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | Recruiting |
| South Texas Accelerated Research Therapeutics (START), LLC | San Antonio | Texas | Recruiting |
| START Mountain Region | West Valley City | Utah | Recruiting |
| The Board of Regents of the University of Wisconsin | Madison | Wisconsin | Recruiting |
| Blacktown Hospital | Blacktown | New South Wales | Recruiting |
| St Vincent's Hospital Sydney | Darlinghurst | New South Wales | Recruiting |
| Melanoma Institute Australia | Wollstonecraft | New South Wales | Recruiting |
| Tasman Oncology Research Ltd | Southport | Queensland | Recruiting |
| Cancer Research SA | Adelaide | South Australia | Recruiting |
| Peninsula and South Eastern Haematology & Oncology Group | Frankston | Victoria | Recruiting |
| Austin Health | Heidelberg | Victoria | Recruiting |
| The Alfred Hospital | Melbourne | Victoria | Recruiting |
| One Clinical Research Pty Ltd | Nedlands | Western Australia | Recruiting |
| Institut Jules Bordet | Anderlecht | Belgium | Recruiting |
| Universitair Ziekenhuis Gent | Ghent | Belgium | Recruiting |
| Centre hospitalier universitaire de Liège | Liège | Belgium | Recruiting |
| Ziekenhuis Aan de Stroom ZAS vzw | Wilrijk | Belgium | Recruiting |
| Chongqing University Cancer Hospital | Chongqing | China | Recruiting |
| Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine | Hangzhou | China | Recruiting |
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | China | Recruiting |
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | China | Recruiting |
| Hubei Cancer Hospital | Wuhan | China | Recruiting |
| Charité - Campus Charité Mitte | Berlin | Germany | Recruiting |
| Universitaetsklinikum Essen | Essen | Germany | Recruiting |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz | Mainz | Germany | Recruiting |
+ 37 more sites — see the full list on the official registry below.
More BioNTech SE trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07070232 on ClinicalTrials.gov ↗ ← All trials in the UK