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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06750185




Registration number
NCT06750185
Ethics application status
Date submitted
12/12/2024
Date registered
27/12/2024
Date last updated
1/07/2025

Titles & IDs
Public title
Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors
Scientific title
A Phase I, First-in-human, Open-label, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BNT317 in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
BNT317-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - BNT317 DL1
Treatment: Other - BNT317 DL2
Treatment: Other - BNT317 DL3
Treatment: Other - BNT317 DL4
Treatment: Other - BNT317 DL5 (intermediate)
Treatment: Other - BNT317 DL6 (intermediate)
Treatment: Other - BNT317 DL7 (additional)

Experimental: BNT317 DL1 - BNT317 monotherapy

Experimental: BNT317 DL2 - BNT317 monotherapy

Experimental: BNT317 DL3 - BNT317 monotherapy

Experimental: BNT317 DL4 - BNT317 monotherapy

Experimental: BNT317 DL5 (optional, intermediate) - BNT317 monotherapy

Experimental: BNT317 DL6 (optional, intermediate) - BNT317 monotherapy

Experimental: BNT317 DL7 (optional, additional) - BNT317 monotherapy


Treatment: Other: BNT317 DL1
Intravenous infusion

Treatment: Other: BNT317 DL2
Intravenous infusion

Treatment: Other: BNT317 DL3
Intravenous infusion

Treatment: Other: BNT317 DL4
Intravenous infusion

Treatment: Other: BNT317 DL5 (intermediate)
Intravenous infusion

Treatment: Other: BNT317 DL6 (intermediate)
Intravenous infusion

Treatment: Other: BNT317 DL7 (additional)
Intravenous infusion
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Occurrence of DLTs
Timepoint [1] 0 0
up to 28 days post IMP administration on Day 1 of Cycle 1 or the day before Cycle 3 Day 1, whichever comes earlier (each cycle is 14 days)
Primary outcome [2] 0 0
Occurrence of treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs)
Timepoint [2] 0 0
from first IMP administration up to 100 days after last dose of IMP or until a new anticancer therapy is initiated
Primary outcome [3] 0 0
Occurrence of dose interruption or discontinuation of study treatment due to TEAEs
Timepoint [3] 0 0
from first IMP administration up to 14 days after the last dose of IMP
Primary outcome [4] 0 0
MTD or the recommended phase two dose (RP2D) of BNT317
Timepoint [4] 0 0
For MTD, up to 28 days post IMP administration on Cycle 1 Day 1 or the day before Cycle 3 Day 1, whichever comes earlier (each cycle is 14 days) or, for RP2D, up to 100 days
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
from first IMP administration up to 100 days after last dose of IMP or until a new anticancer therapy is initiated
Secondary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
from first IMP administration up to 100 days after last dose of IMP or until a new anticancer therapy is initiated
Secondary outcome [3] 0 0
Disease Control Rate (DCR)
Timepoint [3] 0 0
from at least 6 weeks after the first IMP dose up to 100 days after last dose of IMP or until a new anticancer therapy is initiated
Secondary outcome [4] 0 0
PK assessment: The maximum (peak) serum concentration (Cmax) of BNT317
Timepoint [4] 0 0
from pre-dose Cycle 1 to pre-dose Cycle 4 (each cycle is 14 days)
Secondary outcome [5] 0 0
PK assessment: Time to reach maximum (peak) serum concentration (Tmax) of BNT317
Timepoint [5] 0 0
from pre-dose Cycle 1 to pre-dose Cycle 4 (each cycle is 14 days)
Secondary outcome [6] 0 0
PK assessment: Elimination half-life associated with the terminal slope of a semi-logarithmic concentration-time-curve (t1/2) of BNT317
Timepoint [6] 0 0
from pre-dose Cycle 1 to pre-dose Cycle 4 (each cycle is 14 days)
Secondary outcome [7] 0 0
PK assessment: The area under the curve (AUC) from time zero to infinity (mass × time × volume-1) (AUCinf) of BNT317
Timepoint [7] 0 0
from pre-dose Cycle 1 to pre-dose Cycle 4 (each cycle is 14 days)
Secondary outcome [8] 0 0
PK assessment: The AUC from time zero to the end of the dosing period of BNT317
Timepoint [8] 0 0
from pre-dose Cycle 1 to pre-dose Cycle 4 (each cycle is 14 days)
Secondary outcome [9] 0 0
The proportion of participants who are anti-drug antibody (ADA) positive against BNT317
Timepoint [9] 0 0
from first IMP administration up to 100 days after last dose of IMP or until a new anticancer therapy is initiated

Eligibility
Key inclusion criteria
Key

* Have histologically or cytologically confirmed advanced tumors, who have failed standard therapy, or for whom no standard treatment option is available, or for whom standard therapy is not appropriate.
* Have at least one measurable lesion based on RECIST 1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system [CNS] metastasis should not be considered as a measurable lesion).
* Adequate hematologic and organ function.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:

* Any prior treatment which inhibits cluster of differentiation 39 (CD39).
* Vaccination with live attenuated vaccine(s) within 4 weeks prior to the first dose of IMP.
* Any investigational product within 4 weeks or 5 half lives (if the half life of the other investigational product is known), whichever is longer, before the first dose of IMP in this study or ongoing participation in the active treatment phase of another interventional clinical study.
* Systemic cytotoxic chemotherapy, immunotherapy within 3 weeks or five half-lives of the chemotherapy (whichever is shorter) prior to the first dose of IMP.
* Radiation therapy (chest, brain or internal organs) within 4 weeks prior to the first dose of IMP.
* Palliative radiotherapy to metastasis within 2 weeks prior to the first dose of IMP.
* Systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 2 weeks prior to the first dose of IMP. Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short term use (=7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) is allowed.
* Have any of the following CNS metastases:

* Untreated brain metastases that are symptomatic or large (e.g., greater than 2 cm).
* Treated CNS metastases who are not neurologically stable or on steroids or anticonvulsants within 2 weeks before initiating IMP of this study.
* Brain metastases treated with radiotherapy that are not confirmed stable by magnetic resonance imaging or contrast-enhanced computer tomography 4 weeks after radiotherapy.
* Participants with known leptomeningeal metastases.
* Have uncontrolled hypertension or poorly controlled diabetes as specified in the protocol.
* Have a history of allogeneic hematopoietic stem cell transplantation or organ transplantation.
* Have a history of serious Grade =3 immune-related adverse events (irAEs) or irAEs that led to discontinuation of a prior immunotherapy. Participants with a history of Grade =3 irAEs that did not lead to discontinuation of a prior immunotherapy may be included at the discretion of the investigator. If required by the investigator, after consultation with the sponsor.
* Have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/01/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2028
Actual
Sample size
Target
39
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Tasman Oncology Research Ltd - Southport
Recruitment hospital [2] 0 0
Monash Medical Centre Clayton - Clayton
Recruitment hospital [3] 0 0
Scientia Clinical Research - Randwick
Recruitment postcode(s) [1] 0 0
4215 - Southport
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Kentucky
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Rhode Island
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BioNTech SE
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
BioNTech Responsible Person
Address 0 0
BioNTech SE
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BioNTech clinical trials patient information
Address 0 0
Country 0 0
Phone 0 0
+49 6131 9084
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06750185