Dose Escalation Trial of BNT152+153 in Patients With Cancer
Trial status:Recruitment Complete
Trial ID:
BNT152-01C
NCT ID:
EudraCT ID:
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Recruitment Complete
Trial Details
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; the lowest safe dose associated with optimal biological activity) is defined, whichever occurs earlier.
- Group A will be activated first while the time point for Group B activation is at sponsor's decision.
- Part 2 will start after the MTD or MAD or another dose as determined by the SRC have been established for BNT153 and MTD or OBD for BNT152 in Part 1. Part 2 (Part 2A, 2B and 2C) is a dose escalation of BNT152+153 in patients with advanced solid malignancies until the recommended Phase II dose (RP2D) is defined.
- Part 2 may implement a biomarker cohort if a clinical benefit is observed at one or more doses of BNT152+153 that show a clear PD effect in the peripheral blood. The Biomarker Cohort will recruit patients at selected sites.
Medical Condition
Trial Drug
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Phase
Phase 1
Type
Interventional
Estimated Enrolment
86
Estimated Trial Date
Jun 2021 - Sep 2025
Trial Participant Requirements
Age
18+ years
Sex
Female & Male
Healthy Volunteers
No
Trial Locations
Location
Status
Location
Yale Cancer Center
New Haven, Connecticut, United States, 06520
Status
Location
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611
Status
Location
Duke Cancer Center
Durham, North Carolina, United States, 27710
Status
Location
Sarah Cannon Research Institute at Tennessee Oncology
Nashville, Tennessee, United States, 37203
Status
Location
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Status
Location
NEXT Oncology
San Antonio, Texas, United States, 78229
Status