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BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors
Phase 1, PHASE2 trial testing BNT151 in Solid Tumor in 49 participants. Terminated before completion.
| Lead sponsor | BioNTech SE |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 49 |
| Start date | 26 January 2021 |
| Primary completion | 28 May 2024 |
| Estimated completion | 28 May 2024 |
| Sites | 6 locations across United States, Spain |
BioNTech SE — full company profile →
18 and older, any sex, with Solid Tumor. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
| Group | Value | 95% CI |
|---|---|---|
| BNT151 0.4 ug/kg | 0 | |
| BNT151 2.0 ug/kg | 0 | |
| BNT151 4.0 ug/kg | 0 | |
| BNT151 8.0 ug/kg | 2 | |
| BNT151 2.0 + 4.0 ug/kg | 0 |
A TEAE was defined as any adverse event (AE) with an onset date on or after the first administration of IMP (if the AE was absent before the first administration of IMP) or worsened after the first administration of IMP (if the AE was present before the first administration of IMP). AEs with an onset date more than 60 days after the last administration of IMP were considered as treatment emergent only if assessed as related to IMP by the investigator. The intensity of an TEAE was graded according to the NCI CTCAE version 5.0. Grade 3=Severe, Grade 4=Life threatening, Grade 5=Death.
| Group | Value | 95% CI |
|---|---|---|
| BNT151 0.4 ug/kg | 1 | |
| BNT151 2.0 ug/kg | 8 | |
| BNT151 4.0 ug/kg | 24 | |
| BNT151 8.0 ug/kg | 2 | |
| BNT151 2.0 + 4.0 ug/kg | 14 |
| Group | Value | 95% CI |
|---|---|---|
| BNT151 0.4 ug/kg | 0 | |
| BNT151 2.0 ug/kg | 7 | |
| BNT151 4.0 ug/kg | 23 | |
| BNT151 8.0 ug/kg | 2 | |
| BNT151 2.0 + 4.0 ug/kg | 11 |
| Group | Value | 95% CI |
|---|---|---|
| BNT151 0.4 ug/kg | 1 | |
| BNT151 2.0 ug/kg | 3 | |
| BNT151 4.0 ug/kg | 14 | |
| BNT151 8.0 ug/kg | 2 | |
| BNT151 2.0 + 4.0 ug/kg | 5 |
| Group | Value | 95% CI |
|---|---|---|
| BNT151 0.4 ug/kg | 0 | |
| BNT151 2.0 ug/kg | 3 | |
| BNT151 4.0 ug/kg | 8 | |
| BNT151 8.0 ug/kg | 1 | |
| BNT151 2.0 + 4.0 ug/kg | 2 |
| Group | Value | 95% CI |
|---|---|---|
| BNT151 0.4 ug/kg | 0 | |
| BNT151 2.0 ug/kg | 0 | |
| BNT151 4.0 ug/kg | 0 | |
| BNT151 8.0 ug/kg | 0 | |
| BNT151 2.0 + 4.0 ug/kg | 2 |
| Group | Value | 95% CI |
|---|---|---|
| BNT151 0.4 ug/kg | 0 | |
| BNT151 2.0 ug/kg | 3 | |
| BNT151 4.0 ug/kg | 9 | |
| BNT151 8.0 ug/kg | 2 | |
| BNT151 2.0 + 4.0 ug/kg | 4 |
| Group | Value | 95% CI |
|---|---|---|
| BNT151 0.4 ug/kg | 0 | |
| BNT151 2.0 ug/kg | 1 | |
| BNT151 4.0 ug/kg | 5 | |
| BNT151 8.0 ug/kg | 2 | |
| BNT151 2.0 + 4.0 ug/kg | 0 |
| Group | Value | 95% CI |
|---|---|---|
| BNT151 0.4 ug/kg | 0 | |
| BNT151 2.0 ug/kg | 0 | |
| BNT151 4.0 ug/kg | 0 | |
| BNT151 8.0 ug/kg | 1 | |
| BNT151 2.0 + 4.0 ug/kg | 0 |
A TEAE was defined as any AE with an onset date on or after the first administration of IMP (if the AE was absent before the first administration of IMP) or worsened after the first administration of IMP (if the AE was present before the first administration of IMP). AEs with an onset date more than 60 days after the last administration of IMP were considered as treatment emergent only if assessed as related to IMP by the investigator.
| Group | Value | 95% CI |
|---|---|---|
| BNT151 0.4 ug/kg | 0 | |
| BNT151 2.0 ug/kg | 0 | |
| BNT151 4.0 ug/kg | 0 | |
| BNT151 8.0 ug/kg | 0 | |
| BNT151 2.0 + 4.0 ug/kg | 0 |
| Group | Value | 95% CI |
|---|---|---|
| BNT151 0.4 ug/kg | 0 | |
| BNT151 2.0 ug/kg | 0 | |
| BNT151 4.0 ug/kg | 4 | |
| BNT151 8.0 ug/kg | 0 | |
| BNT151 2.0 + 4.0 ug/kg | 2 |
| Group | Value | 95% CI |
|---|---|---|
| BNT151 0.4 ug/kg | 0 | |
| BNT151 2.0 ug/kg | 0 | |
| BNT151 4.0 ug/kg | 2 | |
| BNT151 8.0 ug/kg | 1 | |
| BNT151 2.0 + 4.0 ug/kg | 0 |
ORR was defined as the proportion of participants in whom a complete response (CR) or partial response (PR) (per RECIST version 1.1) was observed as best overall response. Confirmed ORR was defined as the proportion of participants in whom a CR or PR (per RECIST version 1.1) was observed as best overall response and has been confirmed with a subsequent assessment of objective response at least 4 weeks apart.
| Group | Value | 95% CI |
|---|---|---|
| BNT151 0.4 ug/kg | 0 | 0.0 – 97.5 |
| BNT151 2.0 ug/kg | 0 | 0.0 – 36.9 |
| BNT151 4.0 ug/kg | 4.2 | 0.1 – 21.1 |
| BNT151 8.0 ug/kg | 0 | 0.0 – 84.2 |
| BNT151 2.0 + 4.0 ug/kg | 7.1 | 0.2 – 33.9 |
| Group | Value | 95% CI |
|---|---|---|
| BNT151 0.4 ug/kg | 0 | 0.0 – 97.5 |
| BNT151 2.0 ug/kg | 0 | 0.0 – 36.9 |
| BNT151 4.0 ug/kg | 4.2 | 0.1 – 21.1 |
| BNT151 8.0 ug/kg | 0 | 0.0 – 84.2 |
| BNT151 2.0 + 4.0 ug/kg | 7.1 | 0.2 – 33.9 |
DCR was defined as the proportion of participants in whom a CR or PR or stable disease (SD) (per RECIST version 1.1, SD assessed at least 6 weeks after first dose) was observed as best overall response.
| Group | Value | 95% CI |
|---|---|---|
| BNT151 0.4 ug/kg | 0 | 0 – 97.5 |
| BNT151 2.0 ug/kg | 25 | 3.2 – 65.1 |
| BNT151 4.0 ug/kg | 25 | 9.8 – 46.7 |
| BNT151 8.0 ug/kg | 0 | 0 – 84.2 |
| BNT151 2.0 + 4.0 ug/kg | 42.9 | 17.7 – 71.1 |
DOR was defined as the time from first objective response (CR or PR per RECIST version 1.1) to first occurrence of objective tumor progression (progressive disease per RECIST version 1.1) or death from any cause, whichever occurred first. Reporting groups with zero participants with confirmed objective response are not included.
| Group | Value | 95% CI |
|---|---|---|
| BNT151 4.0 ug/kg | 6.5 | NA – NA |
| BNT151 2.0 + 4.0 ug/kg | NA | NA – NA |
Time frame: Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | BNT151 0.4 ug/kg | BNT151 2.0 ug/kg | BNT151 4.0 ug/kg | BNT151 8.0 ug/kg | BNT151 2.0 + 4.0 ug/kg |
|---|---|---|---|---|---|---|
| Pyrexia | General disorders | — | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — | — |
| Pyelonephritis | Infections and infestations | — | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — | — |
| Ascites | Gastrointestinal disorders | — | — | — | — | — |
| Intestinal obstruction | Gastrointestinal disorders | — | — | — | — | — |
| Large intestinal obstruction | Gastrointestinal disorders | — | — | — | — | — |
| Small intestinal obstruction | Gastrointestinal disorders | — | — | — | — | — |
| Influenza like illness | General disorders | — | — | — | — | — |
| Non-cardiac chest pain | General disorders | — | — | — | — | — |
| Hyperbilirubinaemia | Hepatobiliary disorders | — | — | — | — | — |
| Cytokine release syndrome | Immune system disorders | — | — | — | — | — |
| Device related infection | Infections and infestations | — | — | — | — | — |
| Pneumonia | Infections and infestations | — | — | — | — | — |
| Vascular access complication | Injury, poisoning and procedural complications | — | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Hypotension | Vascular disorders | — | — | — | — | — |
| Reaction | System | BNT151 0.4 ug/kg | BNT151 2.0 ug/kg | BNT151 4.0 ug/kg | BNT151 8.0 ug/kg | BNT151 2.0 + 4.0 ug/kg |
|---|---|---|---|---|---|---|
| Lymphocyte count decreased | Investigations | — | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — | — |
| Infusion related reaction | Injury, poisoning and procedural complications | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — | — |
| Fatigue | General disorders | — | — | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — |
| Blood creatinine increased | Investigations | — | — | — | — | — |
| Sinus tachycardia | Cardiac disorders | — | — | — | — | — |
| Asthenia | General disorders | — | — | — | — | — |
| Chills | General disorders | — | — | — | — | — |
| COVID-19 | Infections and infestations | — | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — | — | — |
| Blood alkaline phosphatase increased | Investigations | — | — | — | — | — |
| White blood cell count decreased | Investigations | — | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — | — | — | — |
| Ascites | Gastrointestinal disorders | — | — | — | — | — |
| Cytokine release syndrome | Immune system disorders | — | — | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — | — | — |
| Hypoalbuminaemia | Metabolism and nutrition disorders | — | — | — | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — | — | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — | — |
| Anxiety | Psychiatric disorders | — | — | — | — | — |
| Haematuria | Renal and urinary disorders | — | — | — | — | — |
| Hydronephrosis | Renal and urinary disorders | — | — | — | — | — |
| Micturition urgency | Renal and urinary disorders | — | — | — | — | — |
| Renal failure | Renal and urinary disorders | — | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — | — | — | — |
| Hypotension | Vascular disorders | — | — | — | — | — |
Most-reported serious reactions: Pyrexia, Abdominal pain, Pyelonephritis, Anaemia, Ascites, Intestinal obstruction, Large intestinal obstruction, Small intestinal obstruction.
Data from ClinicalTrials.gov NCT04455620 adverse events section.
This was an open-label, multicenter Phase I/IIa dose escalation, safety, pharmacokinetic and pharmacodynamic (PD) study of BNT151 with expansion cohorts in various solid tumor indications. The study was planned to be performed in Part 1, Part 2A, and Part 2B with adaptive design elements. Part 2 was not conducted because of the clinical study being terminated early. The monotherapy dose escalation, (Part 1) of this clinical study enrolled participants with various solid tumors that are metastatic or of advanced unresectable stage for whom there was no available standard therapy likely to confer clinical benefit, or participants who are not candidates for such available therapy. Dose escalation followed an accelerated titration design, i.e., started with single participant cohorts followed by larger participant cohorts informed by the 3+3 design. Part 1 of the study also planed to implement a dedicated biomarker cohort in BNT151 monotherapy. The biomarker cohort was planned to recruit participants at selected sites in the United States (US) only. The objective of the cohort was to observe PD activity and drug-induced changes in the blood and tumor and only to generate data for exploratory endpoints or additional research. However, the biomarker cohort was not opened, and therefore no data were generated. During combination dose escalation (Part 2A), participants with squamous cell carcinoma of head and neck, and hepatocellular carcinoma were planned to be enrolled and treated with a combination of BNT151 and pembrolizumab. Once Part 2A was completed, participants with renal cell carcinoma, non-small cell lung cancer, and triple negative breast cancer were planned to be enrolled (Part 2B) and treated with a combination of BNT151 with the respective standard of care (SoC).
8 peer-reviewed publications reference this trial (live from Europe PMC):
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