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New hope for advanced cancer? first human trial of BNT3212 begins

NCT ID NCT07147348

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial is testing a new experimental drug called BNT3212, alone or with another drug (pumitamig), in 375 adults with advanced solid tumors who have no other treatment options. The main goals are to check safety, find the right dose, and get an early look at whether the drugs can shrink tumors. Because this is a first-in-human study, the results will be very preliminary.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BNT3212 (an antibody-drug conjugate) and pumitamig (also called BNT327 or PM8002, an immunotherapy)
What this could lead to
If successful, this could point toward a new treatment option for people with advanced solid tumors who have run out of standard therapies.
What could go wrong
This is a very early, first-in-human trial, so safety and effectiveness are not yet known. Many experimental cancer drugs fail in early testing, and side effects may be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 375 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Anhui Provincial Hospital

    RECRUITING

    Hefei, 230061, China

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, 100142, China

  • Cancer Research SA

    RECRUITING

    Adelaide, 5000, Australia

  • First Affiliated Hospital of Xinxiang Medical University

    RECRUITING

    Henan, 453003, China

  • Hunan Province Cancer Hospital

    NOT_YET_RECRUITING

    Hunan, 410006, China

  • Linyi Tumor Hospital

    RECRUITING

    Shandong, 276001, China

  • Monash Medical Centre

    RECRUITING

    Clayton, 3168, Australia

  • One Clinical Research

    NOT_YET_RECRUITING

    Nedlands, 6009, Australia

  • Peter MacCallum Cancer Centre

    RECRUITING

    Melbourne, 3000, Australia

  • Qilu Hospital of Shandong University'

    NOT_YET_RECRUITING

    Shandong, 250062, China

  • Scientia Clinical Research Limited

    RECRUITING

    Randwick, 2031, Australia

  • Shandong University-Jinan Central Hospital

    RECRUITING

    Shandong, 250013, China

  • Shanghai East Hospital

    RECRUITING

    Shanghai, 200120, China

  • Shanghai GoBroad Cancer Hospital

    RECRUITING

    Shanghai, 200131, China

  • Sichuan Cancer Hospital

    RECRUITING

    Sichuan, 610041, China

  • The Alfred Hospital

    RECRUITING

    Melbourne, 3004, Australia

  • Zhejiang Cancer Hospital

    RECRUITING

    Zhejiang, 310022, China

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