drugset / Trial / NCT07070232
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
Phase 1/2
Recruiting
980 enrolled
BioNTech SE
BioNTech (Shanghai) Pharmaceuticals Co., Ltd. · collab
RandomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2025-08-12
- Primary completion
- 2028-02
- Completion
- 2029-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BNT326 | Unknown | — | Intravenous |
| Subject | Itraconazole | Small molecule | — | Oral |
| Subject | Paroxetine | Small molecule | — | Oral |
| Subject | Pumitamig | Protein / enzyme biologic | — | Intravenous |