A Clinical Trial to Test if the Investigational Drug BNT3210 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker Sialyl‑Tn

Trial status:Will Be Recruiting
Trial ID:
BNT3210-01
NCT ID:
NCT07886684
EudraCT ID:
N/A
EU Trial (CTIS) Number:
N/A
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
Collaborator:
BioNTech (Shanghai) Pharmaceuticals Co., Ltd.
Will Be Recruiting

Trial Details

This study is the first time BNT3210 will be tested in people. It will evaluate different dose levels to find suitable doses and to understand how safe the treatment is and how it may help people with advanced solid tumors.

Medical Condition
Solid Tumors
Study Drug
BNT3210
Phase
Phase 1/Phase 2
Type
Interventional
Estimated Enrolment
173
Estimated Trial Date
Nov 2026 - Oct 2029

Trial Participant Requirements

Age
18+ years
Sex
Female & Male
Healthy Volunteers
No
Inclusion and Exclusion Criteria
Inclusion criteria
  • Have Eastern Cooperative Oncology Group performance status of 0 to 1.
  • Have measurable disease by investigator assessment according to RECIST v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  • Have documented disease progression on or after the prior line of therapy.
  • Have an archival formalin-fixed paraffin-embedded tumor tissue sample available or are willing to be biopsied to obtain a fresh tumor tissue sample.
  • Have a life expectancy of ≥3 months in the opinion of the investigator.
  • Have adequate organ, coagulation, and hematologic function as described in the protocol.
  • Have a histologically confirmed advanced/metastatic solid tumor.
  • Have no available standard of care therapy likely to confer clinical benefit in the opinion of the investigator. Participants must have received, be intolerant, or refused all available standard therapies.
Exclusion criteria
  • Have had major surgery within the 4 weeks (or 2 weeks for low-invasive cases, e.g., tumor biopsy, puncture) prior to the first dose of study treatment or are planned to undergo major surgery during the course of the study.
  • Have had prior allogeneic bone marrow transplantation or solid-organ transplantation.
  • Have had an inadequate washout period for prior anti-cancer treatment prior to the first dose of investigational medicinal product (IMP) as defined in the protocol.
  • Have received high doses of systemic steroids (\>10 mg/day of prednisone or its equivalent) or other immunosuppressive therapy within 2 weeks prior to the first dose of IMP or have a condition requiring high doses of systemic steroids or other immunosuppressive therapy.
  • Have received any live attenuated vaccine within 4 weeks prior to the first dose of IMP or intend to receive a live attenuated vaccine during the study.
  • Have spinal cord compression, or clinical or radiologic findings indicative of impending cord compression.
  • Have a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that requires steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
  • Have an active infection that requires systemic therapy within 2 weeks prior to the first dose of IMP.
  • Have any other primary malignancy within 3 years prior to the first dose of IMP.
  • Have unresolved toxicities from previous anti-cancer treatment, defined as toxicities (other than alopecia and pigmentation) not yet resolved according to (US) National Cancer Institute Common Terminology Criteria for Adverse Events version 6.0 Grade ≤1.
  • Have a history of relevant central nervous system (CNS) pathology or current relevant CNS pathology (e.g., seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, Parkinson's disease, epilepsy requiring pharmacologic treatment).
  • Have a QT interval corrected by Fridericia's method (QTcF) prolongation to \>450 ms if male or \>470 ms if female.
  • Have, in the opinion of the treating investigator, any concurrent condition(s) that could pose an undue medical hazard or interfere with the interpretation of the study results.

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

Trial Locations

No locations found.