Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BNT329 · 1 trial · 1 indication
Per dose level.
Per dose level.
Per dose level.
Per dose level. Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) (based on the investigator's assessment) is observed as best overall response.
| Arm | Type | Description |
|---|---|---|
| Dose Escalation - Part A | EXPERIMENTAL | BNT329 administered once every 3 weeks at protocol-defined dose levels |
| Dose Escalation - Part B | EXPERIMENTAL | BNT329 administered once every 2 weeks at protocol-defined dose levels |
| Dose Escalation: Part C | EXPERIMENTAL | BNT329 administered after pre-dosing with a CA19-9 targeting monoclonal antibody |
| Dose Expansion - Part D | EXPERIMENTAL | Participants will be randomized to one of two arms evaluating two different doses as selected from Parts A, B, and/or C |
| Name | Type | Description |
|---|---|---|
| BNT329 | DRUG | Intravenous (IV) infusion |
| CA19-9-targeting monoclonal antibody | DRUG | Monoclonal antibody |
Key Inclusion Criteria All participants and parts: * Have an Eastern Cooperative Oncology Group performance score of 0 to 1 * Have measurable disease per RECIST v1.1, except for ovarian cancer where participants will be evaluated according to Gynecologic Cancer InterGroup criteria. * Have a life e...
BNT329 is an investigational small molecule being developed for the treatment of advanced solid cancers. It is designed for patients whose tumors express the tumor marker CA19-9. The drug is currently being evaluated in a Phase 1 clinical trial to assess its safety and potential benefit in this patient population.
BNT329 targets CA19-9, a tumor-associated antigen that is expressed on the surface of certain cancer cells. By targeting this antigen, the drug aims to selectively attack tumors that carry the CA19-9 marker, potentially offering a treatment option for patients with advanced solid cancers that express this antigen.
BNT329 is being developed by BioNTech SE, a biotechnology company publicly traded under the ticker symbol BNTX. BioNTech is conducting clinical research on this investigational drug to evaluate its safety and efficacy in patients with advanced solid cancers.
BNT329 is currently in Phase 1 clinical development. It is an investigational drug that has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is designed to evaluate the safety, tolerability, and potential clinical benefit of BNT329 in patients with advanced solid tumors expressing CA19-9.
BNT329 is being studied in a Phase 1 clinical trial with the identifier NCT07186842. This trial is currently recruiting participants and aims to enroll approximately 245 patients with advanced solid cancers. The study is being conducted at sites in the United States, Australia, Germany, Spain, and the United Kingdom.