BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT04455620|
Recruitment Status : Not yet recruiting
First Posted : July 2, 2020
Last Update Posted : July 2, 2020
This is an open-label, multicenter Phase I/IIa dose escalation, safety, pharmacokinetic (PK) and pharmacodynamic (PD) trial of BNT151 with expansion cohorts in various solid tumor indications. The trial consists of Part 1, Part 2A and Part 2B with adaptive design elements:
The monotherapy dose escalation (Part 1) of this clinical trial will enroll patients with various solid tumors that are metastatic (Stage IV) or unresectable for whom there is no available standard therapy likely to confer clinical benefit, or patients who are not candidates for such available therapy. During combination dose escalation (Part 2A), patients of different specific solid tumors (one cohort per indication) will be enrolled and treated with a combination of BNT151 and the respective standard of care (SoC) treatment.
Part 2B is the expansion phase where a predefined number of patients in each indication cohort will be treated with the confirmed recommended phase II dose (RP2D) of BNT151 in combination with respective SoC.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Biological: BNT151||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/IIa, First-in-human, Open-label, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors|
|Estimated Study Start Date :||November 2020|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||January 2025|
Experimental: Part 1: BNT151
Monotherapy dose escalation in patients with advanced solid malignancies until the maximum tolerated dose (MTD) and/or RP2D
- Occurrence of dose limiting toxicities (DLTs) within a patient during the DLT evaluation period. [ Time Frame: up to 21 days ]
- Occurrence of treatment emergent adverse event (TEAE) within a patient including Grade ≥3, serious, fatal TEAE by relationship. [ Time Frame: through study completion, an average of 6 months ]The intensity of an TEAE will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v.5.0).
- Occurrence of dose reduction and discontinuation of investigational medicinal product (IMP) within a patient due to TEAE. [ Time Frame: through treatment completion, an average of 4 months ]
- Overall response rate (ORR) is defined as the proportion of patients in whom a complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors [RECIST 1.1]) is observed as best overall response. [ Time Frame: through study completion, an average of 6 months ]
- Disease control rate (DCR) is defined as the proportion of patients in whom a CR or PR or stable disease (SD) (per RECIST 1.1, SD assessed at least 6 weeks after first dose) is observed as best overall response. [ Time Frame: through study completion, an average of 6 months ]
- Duration of response (DOR) is defined as the time from first overall response (CR or PR per RECIST 1.1) to first occurrence of objective tumor progression (Progressive disease (PD) per RECIST 1.1) or death from any cause, whichever occurs first. [ Time Frame: through study completion, an average of 6 months ]
- Time to progression (TPP) is defined as the time from first dose of IMP to objective tumor progression (PD per RECIST 1.1). [ Time Frame: through study completion, an average of 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04455620
|Contact: BioNTech clinical trials patient information||+49 6131 9084 ext firstname.lastname@example.org|
|Contact: BioNTech clinical trial information desk||+49 6131 9084 ext email@example.com|
|Study Director:||BioNTech Responsible Person||BioNTech SE|