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

NCT07886684 | Not Yet Recruiting Phase 1

• 1 other identifier: BNT3210-01
• Study Type: interventional
• Target: 173
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (4)

• Part A only: Occurrence of dose-limiting toxicities (DLTs) during the DLT evaluation period

  Defined as the first 21 days. By dose level.

  Up to 21 days from the initiation of first dose of study treatment

• Occurrence of treatment emergent adverse events (TEAEs) by grade, seriousness, and relatedness

  From first dose of BNT3210 until 35 days after the last dose of BNT3210 or the start of new anti-cancer treatment, whichever is earlier.

  Up to approximately 3 years from first dose of study treatment

• Occurrence of dose interruptions, reductions, and discontinuation of BNT3210 due to TEAEs

  From the time of initiation of the first dose of BNT3210 until administration of the last dose of BNT3210 or the start of new anti-cancer treatment, whichever is earlier.

  Up to approximately 3 years from first dose of study treatment

• Part B only: Objective response rate (ORR)

  Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\] based on the investigator's assessment) is observed as best overall response.

  Up to approximately 3 years from first dose of study treatment

Secondary Outcomes (11)

• PK assessment: Area under the curve (AUC) derived from serum concentrations of BNT3210

  Up to approximately 42 days after last dose of study treatment

• PK assessment: Maximum concentration (Cmax) derived from serum concentrations of BNT3210

  Up to approximately 42 days after last dose of study treatment

• PK assessment: Time to Cmax (Tmax) derived from serum concentrations of BNT3210

  Up to approximately 42 days after last dose of study treatment

• PK assessment: Elimination half-life (t1/2) derived from serum concentrations of BNT3210

  Up to approximately 42 days after last dose of study treatment

• Part A only: ORR

  Up to approximately 3 years from first dose of study treatment

Study Arms (2)

Part A (dose escalation) - BNT3210 monotherapy

EXPERIMENTAL

Escalating dose levels of BNT3210

Drug: BNT3210

Part B (dose optimization) - BNT3210 monotherapy

EXPERIMENTAL

Doses will be as selected from Part A

Drug: BNT3210

Interventions

BNT3210 DRUG

Intravenous infusion

Part A (dose escalation) - BNT3210 monotherapy; Part B (dose optimization) - BNT3210 monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioNTech SE: lead
• BioNTech (Shanghai) Pharmaceuticals Co., Ltd.: collaborator

Study Officials

• BioNTech Responsible Person

  BioNTech SE

  STUDY DIRECTOR

Central Study Contacts

BioNTech clinical trials patient information

CONTACT

+49 6131 9084; patients@biontech.de

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): April 1, 2030
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share