RECRUITING

Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors

Conditions

Advanced Solid Tumor Malignant solid tumors Immunotherapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a first-in-human (FIH), open-label, multiple-site, dose escalation study which will evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of increasing doses of BNT317 in participants with advanced solid tumors.

Official 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

Quick Facts

Study Start:2025-01-13

Study Completion:2028-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06750185

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* Have received any of the following therapies or drugs within the noted time intervals prior to trial 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. * Broad-spectrum intravenous antibiotics therapy within 2 weeks prior to the first dose of IMP. * Any investigational product within 4 weeks before the first dose of IMP in this trial or ongoing participation in the active treatment phase of another interventional clinical trial. * Systemic cytotoxic chemotherapy, immunotherapy within 4 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 a single area of 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 trial. * Participants with known leptomeningeal metastases. * Have uncontrolled hypertension or poorly controlled diabetes. * 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. Patients 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).

Inclusion Criteria

Exclusion Criteria

* 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.

* Have received any of the following therapies or drugs within the noted time intervals prior to trial 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.
* Broad-spectrum intravenous antibiotics therapy within 2 weeks prior to the first dose of IMP.
* Any investigational product within 4 weeks before the first dose of IMP in this trial or ongoing participation in the active treatment phase of another interventional clinical trial.
* Systemic cytotoxic chemotherapy, immunotherapy within 4 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 a single area of 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 trial.
* Participants with known leptomeningeal metastases.
* Have uncontrolled hypertension or poorly controlled diabetes.
* 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. Patients 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).

Contacts and Locations

Study Contact

BioNTech clinical trials patient information

CONTACT

+49 6131 9084

patients@biontech.de

Principal Investigator

BioNTech Responsible Person

STUDY_DIRECTOR

BioNTech SE

Study Locations (Sites)

START Midwest

Grand Rapids, Michigan, 49546

United States

Carolina BioOncology Institute, LLC

Huntsville, North Carolina, 28078

United States

South Texas Accelerated Research Therapeutics (START), LLC

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: BioNTech SE

BioNTech Responsible Person, STUDY_DIRECTOR, BioNTech SE

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-13

Study Completion Date2028-06

Study Record Updates

Study Start Date2025-01-13

Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

Malignant solid tumors
Immunotherapy

Additional Relevant MeSH Terms

Advanced Solid Tumor