Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT07070232
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
BioNTech SE
Organization:
Study Overview
Official Title:
A Phase I/II, Open-label, Adaptive Two-part Trial to Evaluate the Safety, Efficacy, Optimal Dose and Pharmacokinetics of BNT326 as Monotherapy and in Combination With Cancer Immunotherapies in Participants With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2025-11
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 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.
Detailed Description:
Both parts (Part 1 and Part 2) will start enrolling study participants independent of each other.
In Part 1, participants with histologically or cytologically confirmed advanced solid tumors will receive BNT326 monotherapy in the following cohorts:
* Cohort 1A: Cutaneous melanoma (second-line or higher \[2L+\]).
* Cohort 1B: Actionable oncogenic alterations (AGA)-negative non-small cell lung cancer (NSCLC) 2L+.
* Cohort 1C: Epithelial growth factor receptor mutated (EGFRm) NSCLC 2L+.
* Cohort 1D: Rare melanoma (acral/uveal/mucosal melanoma).
* Cohort 1E: Other advanced solid tumors.
* Cohort 1F (drug-drug interaction \[DDI\] Cohort): Advanced solid tumors.
In Part 2, BNT326 will be studied in combination with other immunotherapeutic agents. The first combination treatment will be BNT326 with BNT327. The following cohorts are planned:
* Cohort 2A: Cutaneous melanoma 2L+.
* Cohort 2B: Human epidermal growth factor receptor 2 (HER2)-negative breast cancer.
Participants in Cohorts 1A, 1B, and 1C will be randomized to one of two dose levels of BNT326 in a 1:1 ratio. The sponsor may choose to open a dose randomization cohort in Cohort 2A for further dose optimization after dose escalation. No randomization is planned for Cohorts 1D, 1E, 1F, and 2B.
The study will consist of a screening period, a treatment period, a safety follow-up period, an efficacy follow-up period, and a long-term survival follow-up period. Study treatment will be continued for up to 24 months or until disease progression, withdrawal of consent, termination of the study by the sponsor, or unacceptable toxicity. For each participant, the treatment and follow-up periods are projected to be completed within \~38 months (Part 1) and \~48 months (Part 2), unless participants are continuing to benefit from treatment per investigator's recommendation and upon sponsor approval.
In Part 1, participants with histologically or cytologically confirmed advanced solid tumors will receive BNT326 monotherapy in the following cohorts:
* Cohort 1A: Cutaneous melanoma (second-line or higher \[2L+\]).
* Cohort 1B: Actionable oncogenic alterations (AGA)-negative non-small cell lung cancer (NSCLC) 2L+.
* Cohort 1C: Epithelial growth factor receptor mutated (EGFRm) NSCLC 2L+.
* Cohort 1D: Rare melanoma (acral/uveal/mucosal melanoma).
* Cohort 1E: Other advanced solid tumors.
* Cohort 1F (drug-drug interaction \[DDI\] Cohort): Advanced solid tumors.
In Part 2, BNT326 will be studied in combination with other immunotherapeutic agents. The first combination treatment will be BNT326 with BNT327. The following cohorts are planned:
* Cohort 2A: Cutaneous melanoma 2L+.
* Cohort 2B: Human epidermal growth factor receptor 2 (HER2)-negative breast cancer.
Participants in Cohorts 1A, 1B, and 1C will be randomized to one of two dose levels of BNT326 in a 1:1 ratio. The sponsor may choose to open a dose randomization cohort in Cohort 2A for further dose optimization after dose escalation. No randomization is planned for Cohorts 1D, 1E, 1F, and 2B.
The study will consist of a screening period, a treatment period, a safety follow-up period, an efficacy follow-up period, and a long-term survival follow-up period. Study treatment will be continued for up to 24 months or until disease progression, withdrawal of consent, termination of the study by the sponsor, or unacceptable toxicity. For each participant, the treatment and follow-up periods are projected to be completed within \~38 months (Part 1) and \~48 months (Part 2), unless participants are continuing to benefit from treatment per investigator's recommendation and upon sponsor approval.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-517261-16-00 | CTIS | None | View |