Clinical trial Recruiting at 14 sites Phase1; Phase2 Interventional Ages 18 and up

First-in-human dose escalation and expansion of BNT3212 alone or with BNT327 for adults with advanced solid tumors

Official title: A Phase I/II, First-in-human, Open-label, Dose Escalation and Indication Expansion Study of the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors

Run by BioNTech SE · NCT07147348 · Data updated 2026-11-12

This trial will test BNT3212 by itself and together with pumitamig (BNT327) in adults with advanced solid tumors who have exhausted standard treatment options.

More Advanced Solid Tumor trials

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment375 (estimated)
SponsorBioNTech SE
Industry-sponsored
Drugs / interventionsimmunotherapy
Locations17 sites (Adelaide and 16 other locations)
StatusRecruiting
StartedAugust 27, 2025
Main results expectedNovember 2027
Study endsAugust 2028
Registry record updatedJune 15, 2026
Trial IDNCT07147348 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with histologically or cytologically confirmed locally advanced, recurrent, or metastatic solid tumors with at least one measurable lesion, ECOG performance status 0–1, adequate organ and cardiac function, life expectancy ≥3 months, and prior standard therapies exhausted or inappropriate are the intended participants.

Probably not a fit

Patients with poor performance status (ECOG ≥2), uncontrolled comorbidities, inadequate organ or cardiac function, very limited life expectancy, or who still have effective standard treatment options are unlikely to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, open-label, multi-site study using a stepwise four-part design to find safe and active dose(s) for BNT3212 alone and in combination with pumitamig (BNT327). Part A and C are dose-escalation cohorts (monotherapy and combination, respectively) and Parts B and D are dose-expansion cohorts across selected tumor indications. Key data collected will include safety, tolerability, pharmacokinetics, immunogenicity, biomarker profiles, and preliminary efficacy measures such as RECIST responses. Results will be used to identify a recommended dose for further testing while continuously monitoring participant safety.

Why it matters

Potential benefit: If successful, the regimen could provide a new treatment option that shrinks tumors or slows disease progression for patients with advanced solid tumors who have few other options.

How similar studies have gone: Combining immune checkpoint inhibition with anti-VEGF therapy has shown benefit in several cancers (for example atezolizumab plus bevacizumab), but PD-L1/VEGF-A bispecific antibodies are a novel approach with limited published first-in-human results so far.

Who can join: the full rules

Show full inclusion / exclusion criteria
Key Inclusion Criteria:

* Participants with histologically or cytologically confirmed locally advanced, recurrent, or metastatic solid tumors that have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease; or for whom the standard therapy is considered inappropriate or intolerable.
* Have at least one measurable lesion based on RECIST v1.1.
* Eastern Cooperative Oncology Group performance status of 0 (fully active, able to carry out all pre-disease activities without restriction) or 1 (unable to perform physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature).
* Predicted life expectancy of ≥3 months.
* Left ventricular ejection fraction ≥50% by either echocardiography or multigated acquisition scan within 28 days prior to first dose of study treatment.
* Adequate liver, renal, hematological, and coagulation function.
* Recovery to Grade 0-1 (or baseline) from adverse reactions related to prior anti cancer therapy except for:

  * Asymptomatic laboratory abnormalities such as elevated alkaline phosphatase, hyperuricemia, elevated serum amylase/lipase, and elevated blood glucose.
  * Toxicity that the investigator determined to have no safety risk, such as alopecia, Grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement therapy, etc.
* The investigator considers discontinuation of protocol-defined anti-cancer therapies and restricted medications with protocol-defined washout periods as medically acceptable.
* For Parts B and D only: Participants must be diagnosed with specific indications.

Key Exclusion Criteria:

* Active infection (e.g., bacterial or fungal infections) requiring systemic treatment (e.g., severe pneumonia, bacteremia, sepsis), except oral antibiotics.
* Participants with primary central nervous system (CNS) malignancies.
* Active CNS metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
* Unstable pleural effusion or ascites requiring thoracentesis or paracentesis within 14 days prior to initiation of study treatment.
* Have active, or a history of, pneumonitis requiring treatment with steroids, or has active, or a history of, interstitial lung disease.
* Clinically significant pulmonary complications.
* History of severe cardiovascular disease.
* Have a history of significant hematologic toxicity to prior lines of therapy, as assessed by investigator, e.g., Grade 4 febrile neutropenia or recurrent/persistent Grade 3 to 4 neutropenia.
* Have active or chronic corneal disorders or with any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy.
* Have uncontrolled hypertension while on antihypertensive medicine or poorly controlled diabetes.
* Concurrent malignancy within 5 years prior to study enrollment. Exceptions: basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ after radical resection.
* Unstable thrombotic event (e.g., deep vein thrombosis, arterial thrombosis, pulmonary embolism).
* Have adverse reactions from prior anti-tumor therapy that have not returned to Grade 1 (graded by NCI CTCAE v5.0 criteria) or below (unless the investigator determines that certain AEs pose no safety risk to participants, such as hair loss, Grade 2 peripheral neuropathy or stable hypothyroidism under hormone replacement therapy) are not eligible for the study.
* For Parts C and D only: Prior treatment with PD-1/L1 and VEGF-A antibody combinations (including bispecific antibodies to PD-1/L1 and VEGF-A).
* For Parts C and D only: Have active, or history of, autoimmune disease with risk of exacerbation following PD-L1 inhibition OR an immune deficiency (e.g., allogeneic hematopoietic stem cell transplantation or organ transplantation). Participants with protocol-specified conditions may be eligible.
* For Parts C and D only: Have serious non-healing wounds, ulcer, or bone fracture.
* For Parts C and D only: Have evidence of major coagulation disorders or other significant risks of hemorrhage.
* For Parts C and D only: Have a history of serious Grade 3 or higher immune-related adverse events that led to treatment discontinuation of a prior immunotherapy.
* For Parts C and D only: Have a history of small bowel obstruction requiring hospitalization within the past 3 months prior to the first dose of IMP.
* For Parts C and D only: Have received:

  * Anticoagulant therapy for therapeutic purposes (except low molecular weight heparin) within 14 days prior to the first dose of IMP.
  * Antiplatelet drugs within 10 days prior to the initiation of study treatment.

NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Where it's running

  • Cancer Research SA
    Adelaide, Australia
    Recruiting
  • Monash Medical Centre
    Clayton, Australia
    Recruiting
  • Peter MacCallum Cancer Centre
    Melbourne, Australia
    Recruiting
  • The Alfred Hospital
    Melbourne, Australia
    Recruiting
  • Scientia Clinical Research Limited
    Randwick, Australia
    Recruiting
  • Beijing Cancer Hospital
    Beijing, China
    Recruiting
Show 11 more locations
  • Anhui Provincial Hospital
    Hefei, China
    Recruiting
  • First Affiliated Hospital of Xinxiang Medical University
    Henan, China
    Recruiting
  • Shandong University-Jinan Central Hospital
    Shandong, China
    Recruiting
  • Linyi Tumor Hospital
    Shandong, China
    Recruiting
  • Shanghai East Hospital
    Shanghai, China
    Recruiting
  • Shanghai GoBroad Cancer Hospital
    Shanghai, China
    Recruiting
  • Sichuan Cancer Hospital
    Sichuan, China
    Recruiting
  • Zhejiang Cancer Hospital
    Zhejiang, China
    Recruiting
  • One Clinical Research
    Nedlands, Australia
    Not yet recruiting
  • Hunan Province Cancer Hospital
    Hunan, China
    Not yet recruiting
  • Qilu Hospital of Shandong University'
    Shandong, China
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.