> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-first-in-human-dose-escalation-and-indication-expansion-edbbfe5e-4028-4a45-935d-23b663c8ae06 > Record changed: 2026-11-04 # A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors NCT07147348 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) Participants 375 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) Lead sponsor BioNTech SE Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) Start date 2025-08-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) Number of sites 17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) ## Title and summary **Summary** The aim of this first-in-human (FIH) open-label, multi-site study is to evaluate safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary clinical efficacy of BNT3212, including identification of the recommended dose of BNT3212 for use as monotherapy and with pumitamig (also known as BNT327 or PM8002) as combination therapy, in adults with advanced solid tumors who have exhausted other treatment options. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) **Short title** A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) ## Dates **Completion date** 2028-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) **First posted** 2025-08-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) **Registry last updated** 2026-06-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) **Primary completion date** 2027-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) **Start date** 2025-08-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) ## Size and sites **Participants** 375 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) **Planned participants** 375 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) **Number of sites** 17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) **Lead sponsor** BioNTech SE Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) ## Identifiers **Registry ID** NCT07147348 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) **ClinicalTrials.gov ID** NCT07147348 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) ## Outcomes ### Primary outcomes 1. Parts A and C - Occurrence of dose limiting toxicities (DLTs) within a participant during the DLT observation period Timeframe: Up to 28 days after first dose of investigational medicinal product (IMP). Per cohort. 2. All parts - Percentage of participants with treatment-emergent adverse events (TEAEs) including Grade ≥3, serious, and fatal TEAEs by relationship Timeframe: From the time of the first dose of IMP until 90 days after the last dose of IMP, approximately up to 31 months. Per cohort. Adverse events (AEs) graded according to the National Cancer Institute Common Terminology Criteria for AEs version 5.0 (NCI CTCAE v5.0). 3. Parts A and C - Percentage of participants with dose interruptions or discontinuations of study treatment due to TEAEs Timeframe: From the time of the first until last dose of IMP, approximately up to 31 months. Per cohort. 4. Parts B and D - Percentage of participants with dose interruptions, reductions or discontinuations of study treatment due to TEAEs Timeframe: From the time of the first until last dose of IMP, approximately up to 31 months. Per cohort. 5. Parts B and D (expansion cohorts) - Objective response rate (ORR) Timeframe: From first dose of IMP until end of study, approximately up to 31 months. Per cohort. ORR defined as the percentage 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. ### Secondary outcomes 1. All parts - PK assessment: Maximum concentration (Cmax) derived from serum/plasma concentrations Timeframe: From predose to 28 days after first dose of IMP. Per cohort. For BNT3212 (conjugated antibody, total antibody, and unconjugated derivative of camptothecin, topoisomerase I inhibitor \\\[iCPT\\\]) and for pumitamig if in the combination cohorts, as data permits. 2. All parts - PK assessment: Area under the concentration-time curve (AUC0-t) derived from serum/plasma concentrations Timeframe: From predose to 28 days after first dose of IMP. Per cohort. For BNT3212 (conjugated antibody, total antibody, and unconjugated iCPT) and for pumitamig if in the combination cohorts, as data permits. 3. All parts - PK assessment: Minimum concentration (Ctrough) derived from serum/plasma concentrations Timeframe: From predose until 90 days after the last dose of IMP. Per cohort. For BNT3212 (conjugated antibody, total antibody, and unconjugated iCPT) and for pumitamig if in the combination cohorts, as data permits. 4. All parts - Anti-drug antibody (ADA) prevalence Timeframe: For up to 90 days from the last dose of IMP. Per cohort and by dose level, derived from serum samples. Prevalence defined as the percentage of participants who are ADA positive (either baseline or post baseline), if data permits. 5. All parts - ADA incidence Timeframe: For up to 90 days from the last dose of IMP. Per cohort and by dose level, derived from serum samples. Incidence defined as the percentage of participants having treatment-emergent ADA, if data permits. 6. All parts - Disease control rate (DCR) Timeframe: From first dose of IMP until end of study, approximately up to 31 months. Per cohort. DCR defined as the percentage of participants with confirmed CR, PR, or stable disease (per RECIST v1.1 based on the investigator's assessment) as best overall response. 7. All parts - Duration of response (DOR) Timeframe: From first dose of IMP until end of study, approximately up to 31 months. Per cohort. DOR defined as the time from first confirmed objective response (CR or PR per RECIST v1.1 based on the investigator's assessment) to first occurrence of objective tumor progression (progressive disease \\\[PD\\\] per RECIST v1.1 based on the investigator's assessment) or death from any cause, whichever occurs first. 8. All parts - Progression free survival (PFS) Timeframe: From first dose of IMP until end of study, approximately up to 31 months. Per cohort. PFS based on the investigator's assessment defined as the time from first dose of trial treatment to the first objective tumor progression (PD per RECIST v1.1) or death from any cause, whichever occurs first. 9. All parts - Time to response (TTR) Timeframe: From first dose of IMP until end of study, approximately up to 31 months. Per cohort. TTR, defined as the time from first dose of trial treatment to first confirmed objective response (CR or PR per RECIST v1.1 based on the investigator's assessment) in participants with a confirmed objective response. 10. All parts - Overall survival (OS) Timeframe: From first dose of IMP until end of study, approximately up to 31 months. Per cohort. OS defined as the time from first dose of trial treatment to death from any cause. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) ## Sites - Cancer Research SAAdelaide, AustraliaRecruiting - Monash Medical CentreClayton, AustraliaRecruiting - Peter MacCallum Cancer CentreMelbourne, AustraliaRecruiting - The Alfred HospitalMelbourne, AustraliaRecruiting - One Clinical ResearchNedlands, AustraliaNot yet recruiting - Scientia Clinical Research LimitedRandwick, AustraliaRecruiting - Beijing Cancer HospitalBeijing, ChinaRecruiting - Anhui Provincial HospitalHefei, ChinaRecruiting - First Affiliated Hospital of Xinxiang Medical UniversityHenan, ChinaRecruiting - Hunan Province Cancer HospitalHunan, ChinaNot yet recruiting - Shandong University-Jinan Central HospitalShandong, ChinaRecruiting - Qilu Hospital of Shandong University'Shandong, ChinaNot yet recruiting - Linyi Tumor HospitalShandong, ChinaRecruiting - Shanghai East HospitalShanghai, ChinaRecruiting - Shanghai GoBroad Cancer HospitalShanghai, ChinaRecruiting - Sichuan Cancer HospitalSichuan, ChinaRecruiting - Zhejiang Cancer HospitalZhejiang, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) ## References ### Other registry identifiers - CTR20253266 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07147348) ## Related records ### Drugs (1) - [Pumitamig](https://trialight.com/data/asset/pumitamig-717b3828-e2b9-5bbd-9ac3-6e9a79c63a15.md) ### Collaborators (2) - BioNTech (Shanghai) Pharmaceuticals Co., Ltd. - Biotheus (Hengqin) Co., Ltd. ### Lead sponsors (1) - [BioNTech SE](https://trialight.com/data/company/biontech-se-85cb6dcc-6a40-467f-aab1-af1123099f83.md) ### Conditions (2) - [Autosomal dominant Parkinson disease 4](https://trialight.com/data/condition/autosomal-dominant-parkinson-disease-4-b4f9a6fc-46e0-5768-a3e6-a9282e6fc837.md) - [Neoplasm](https://trialight.com/data/condition/neoplasm-2a973797-359b-5982-907e-98f9b7c1a284.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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