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Advanced Solid Tumor / BNT317 DL4 / BNT317 DL1 · Phase 1/2 Trial
ClinicalTrials.gov · September 9, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a clinical trial registration for a first-in-human, open-label Phase 1/2 study of BNT317, a biological investigational therapy in advanced solid tumors. No efficacy or safety results are posted in this registry record; the study is currently recruiting. This record documents the planned design and endpoints only and cannot support any clinical inference about the drug's safety or effectiveness.
Phase 1/2, Interventional, Randomized, Sequential, Open label, Treatment purpose. Advanced Solid Tumor; age from 18 Years. Intervention: Part A - BNT317 DL1; Part A - BNT317 DL2; Part A - BNT317 DL3; Part A - BNT317 DL4; Part A - BNT317 DL5; Part A - BNT317 DL6 (optional); Part B1 - BNT317 selected DLA; Part B1 - BNT317 selected DLB; Part B2 - BNT317 selected DLA plus SoC c…. Compared with: Standard-of-care chemotherapy options (SoC chemotherapy 1 and SoC chemotherapy 2) in expansion cohorts; no comparator in dose-escalation phase. n = 248. 11 sites: United States, Australia.
This is a clinical trial registration for a first-in-human, open-label Phase 1/2 study of BNT317, a biological investigational therapy in advanced solid tumors. No efficacy or safety results are posted in this registry record; the study is currently recruiting. This record documents the planned design and endpoints only and cannot support any clinical inference about the drug's safety or effectiveness.
No efficacy data, safety data, pharmacokinetic data, or immunogenicity data are available in this record
This record describes a study under recruitment with no available results. Clinicians and researchers should not infer any therapeutic effect or safety profile from this registration alone. Results are expected from Parts B1–B3 (expansion cohorts examining ORR) once accrual and follow-up are complete.
First-in-human Phase 1/2 study registration with no posted results; safety and dose-escalation design in early development stage.
As stated by the source record.
Quoted from the source exactly as published.
This record describes a study under recruitment with no available results. Clinicians and researchers should not infer any therapeutic effect or safety profile from this registration alone. Results are expected from Parts B1–B3 (expansion cohorts examining ORR) once accrual and follow-up are complete.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06750185). This is a study registration, not published results. Lead sponsor: BioNTech SE. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 248 participants (ESTIMATED). Conditions: Advanced Solid Tumor. Interventions: BIOLOGICAL: BNT317 DL1; BIOLOGICAL: BNT317 DL2; BIOLOGICAL: BNT317 DL3; BIOLOGICAL: BNT317 DL4; BIOLOGICAL: BNT317 DL5; BIOLOGICAL: BNT317 DL6; BIOLOGICAL: BNT317 selected DLA; BIOLOGICAL: BNT317 selected DLB; DRUG: SoC chemotherapy 1; DRUG: SoC chemotherapy 2. Primary outcome measures: Part A - Occurrence of DLTs , Up to 28 days after initiating BNT317 administration on Day 1 of Cycle 1 or the day before Cycle 3 Day 1, whichever comes earlier (each cycle is 14 days); All parts - Occurrence of treatment-emergent adverse events (TEAEs), Grade ≥3 TEAEs, serious adverse events (SAEs), treatment-related adverse events (TRAEs), treatment-related Grade ≥3 TEAEs, and treatment-related SAEs , From the first dose of BNT317 up to 100 days after last dose of IMP or until a new anticancer therapy is initiated; All parts - Occurrence of dose interruption, reductions, and discontinuation of BNT317 due to TEAEs , From the first dose of BNT317 up to 100 days after last dose of IMP or until a new anticancer therapy is initiated; Parts B1, B2 & B3: Objective Response Rate (ORR) , From the first dose of BNT317 up to 100 days after last dose of IMP or until a new anticancer therapy is initiated. Brief summary: This is a first-in-human (FIH), open-label, multi-site study which will evaluate the safety, efficacy, tolerability, pharmacokinetics (PK), and immunogenicity of increasing doses of BNT317 in participants with advanced solid tumors.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.