Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 12:49 PM
Study NCT ID:
NCT07455734
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early-phase Trial to Assess the Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors
Sponsor:
BioNTech SE
Organization:
Study Overview
Official Title:
A Phase I/IIa, First-in-human, Open-label, Multi-site, Multi-regional, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is the first time the drug BNT3214 (also referred to as PM8102) will be tested in people. It is designed to find out if the drug is safe and how well it works for adults with advanced solid tumors. The study will have three parts. The first two parts (Parts A and B) will focus on testing different amounts of BNT3214 to figure out the best and safest dose. The third part (Part C) will test selected doses of BNT3214 in multiple types of cancer.
Detailed Description:
Parts A and B will investigate the safety and tolerability of BNT3214. Part B is optional and will only be opened if emerging data from Part A indicates that an alternative BNT3214 dosing schedule may have a better benefit-risk profile for further development. Based on the available safety, pharmacokinetics (PK) or preliminary overall response data from Parts A and B, the study may progress to Part C. A study internal review committee will oversee the study to evaluate safety data as the study progresses and/or may recommend the dose levels (DLs) for the dose expansion, possible changes in the schedule of dosing, and expansion indications based on the totality of available data.
There will be no randomization in Parts A and B or the dose expansion cohorts of Part C. In the dose optimization cohorts of Part C, eligible participants will be randomized to one of two DLs selected from Parts A and B. In the dose expansion cohorts, participants will be enrolled into indication-specific cohorts as predefined or may be adjusted per safety, efficacy signals from Parts A and/or B.
Participants will receive BNT3214 for a maximum of 2 years or until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), unacceptable toxicity, withdrawal of consent, loss of clinical benefit as determined by the investigator, lost to follow-up, death, or until the sponsor terminates the study or any other criterion for discontinuation is met, whichever occurs first.
There will be no randomization in Parts A and B or the dose expansion cohorts of Part C. In the dose optimization cohorts of Part C, eligible participants will be randomized to one of two DLs selected from Parts A and B. In the dose expansion cohorts, participants will be enrolled into indication-specific cohorts as predefined or may be adjusted per safety, efficacy signals from Parts A and/or B.
Participants will receive BNT3214 for a maximum of 2 years or until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), unacceptable toxicity, withdrawal of consent, loss of clinical benefit as determined by the investigator, lost to follow-up, death, or until the sponsor terminates the study or any other criterion for discontinuation is met, whichever occurs first.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: