Dose Escalation Trial of BNT152+153 in Patients With Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04710043|
Recruitment Status : Recruiting
First Posted : January 14, 2021
Last Update Posted : September 9, 2021
This is an open-label, multisite Phase I dose escalation, safety, pharmacokinetics (PK) and pharmacodynamics (PD) trial of BNT152+153 in various solid tumor indications.
The clinical trial will enroll patients with various solid tumors that are metastatic 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.
The trial consists of Part 1 and Part 2 with adaptive design elements:
Part 1 consists of Groups A and B.
- Group A is a BNT153 monotherapy dose escalation in patients with advanced solid malignancies until the maximal tolerated dose (MTD) is defined. If MTD is not reached, maximum administered dose (MAD) may be used for further development (or another dose as determined by the safety review committee (SRC).
- Group B is a BNT152 monotherapy dose escalation in patients with advanced solid malignancies until the MTD or optimal biological dose (OBD) is defined, whichever occurs earlier.
- Group A will be activated first and activation of Group B is at sponsor's decision.
- Part 2 will start once Part 1 is completed, i.e., dose escalations for both BNT152 and BNT153 monotherapy are completed.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Drug: BNT152 Drug: BNT153||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I, First-in-human, Open-label, Dose Escalation Trial to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of BNT152+153 in Patients With Solid Tumors|
|Actual Study Start Date :||June 8, 2021|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||July 2023|
Experimental: Part 1 group A BNT153
Monotherapy dose escalation.
Experimental: Part 1 group B BNT152
Monotherapy dose escalation.
- Occurrence of treatment-emergent adverse events (TEAEs) including Grade ≥ 3, serious, fatal TEAE by relationship [ Time Frame: up to 24 months ]TEAEs will be graded according to 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: up to 24 months ]
- Occurrence of dose limiting toxicities (DLTs) during the DLT evaluation period - BNT152 [ Time Frame: 21 days ]
- Occurrence of DLTs during the DLT evaluation period - BNT153 [ Time Frame: 21 days ]
- Overall response rate (ORR) [ Time Frame: up to 24 months ]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 version 1.1 (RECIST v1.1) is observed as best overall response.
- Disease control rate (DCR) [ Time Frame: up to 24 months ]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.
- Duration of response (DOR) [ Time Frame: up to 24 months ]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.
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): NCT04710043
|Contact: BioNTech clinical trials patient information||+49 6131 9084 ext email@example.com|
|Contact: BioNTech clinical trial information desk||+49 6131 9084 ext firstname.lastname@example.org|
|United States, Connecticut|
|Yale Cancer Center||Recruiting|
|New Haven, Connecticut, United States, 06510|
|United States, Tennessee|
|Sarah Cannon Research Institute at Tennessee Oncology||Recruiting|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|San Antonio, Texas, United States, 78229|
|Study Director:||BioNTech Responsible Person||BioNTech SE|