New hope for advanced cancer? first human trial of BNT3212 begins
NCT ID NCT07147348
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 375 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
17 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Anhui Provincial Hospital
RECRUITINGHefei, 230061, China
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Beijing Cancer Hospital
RECRUITINGBeijing, 100142, China
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Cancer Research SA
RECRUITINGAdelaide, 5000, Australia
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First Affiliated Hospital of Xinxiang Medical University
RECRUITINGHenan, 453003, China
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Hunan Province Cancer Hospital
NOT_YET_RECRUITINGHunan, 410006, China
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Linyi Tumor Hospital
RECRUITINGShandong, 276001, China
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Monash Medical Centre
RECRUITINGClayton, 3168, Australia
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One Clinical Research
NOT_YET_RECRUITINGNedlands, 6009, Australia
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Peter MacCallum Cancer Centre
RECRUITINGMelbourne, 3000, Australia
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Qilu Hospital of Shandong University'
NOT_YET_RECRUITINGShandong, 250062, China
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Scientia Clinical Research Limited
RECRUITINGRandwick, 2031, Australia
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Shandong University-Jinan Central Hospital
RECRUITINGShandong, 250013, China
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Shanghai East Hospital
RECRUITINGShanghai, 200120, China
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Shanghai GoBroad Cancer Hospital
RECRUITINGShanghai, 200131, China
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Sichuan Cancer Hospital
RECRUITINGSichuan, 610041, China
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The Alfred Hospital
RECRUITINGMelbourne, 3004, Australia
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Zhejiang Cancer Hospital
RECRUITINGZhejiang, 310022, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors