Bintrafusp Alfa
drug drugOn this page
Also known as 8L9YQ2N6PAM-7824M7824MSB-0011359CMsb0011359c
Summary
Bintrafusp Alfa (CHEMBL4298024) is a phase-3 clinical-stage protein; indicated across 31 conditions including non-small cell lung carcinoma and lung neoplasm.
At a glance
- Status: Max clinical phase 3 (not approved)
- Modality: Protein
- Indications: 31 conditions
- Clinical trials: 55
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL4298024 |
| Name | Bintrafusp Alfa |
| Type | Protein |
| Max phase | 3 |
Also known as: 8L9YQ2N6PA, Bintrafusp alfa, M-7824, M7824, MSB-0011359C, Msb0011359c, MSB0011359C, BINTRAFUSP ALFA
Targets
Targets
No target linkage available.
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
26 diseases in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.
| Disease (in trials) | Phase | MONDO | EFO |
|---|---|---|---|
| non-small cell lung carcinoma | 3 | MONDO:0005233 | EFO:0003060 |
| lung neoplasm | 3 | MONDO:0021117 | MONDO:0008903 |
| head and neck squamous cell carcinoma | 2 | MONDO:0010150 | EFO:0000181 |
| breast carcinoma | 2 | MONDO:0004989 | EFO:0000305 |
| cervical adenocarcinoma | 2 | MONDO:0005153 | EFO:0001416 |
| breast neoplasm | 2 | MONDO:0021100 | MONDO:0007254 |
| colorectal adenocarcinoma | 2 | MONDO:0005008 | EFO:0000365 |
| cholangiocarcinoma | 2 | MONDO:0019087 | EFO:0005221 |
| thymoma | 2 | MONDO:0006456 | EFO:1000581 |
| intrahepatic cholangiocarcinoma | 2 | MONDO:0003210 | EFO:1001961 |
| carcinoma of esophagus | 2 | MONDO:0019086 | EFO:0002916 |
| soft tissue sarcoma | 2 | MONDO:0018078 | EFO:1001968 |
| mesothelioma | 2 | MONDO:0005065 | EFO:0000588 |
| gallbladder neoplasm | 2 | MONDO:0021253 | MONDO:0005411 |
| metastatic prostate carcinoma | 1 | MONDO:0004956 | EFO:0000196 |
| neoplasm | 1 | MONDO:0005070 | EFO:0000616 |
| small cell lung carcinoma | 1 | MONDO:0008433 | EFO:0000702 |
| Kaposi’s sarcoma | 1 | MONDO:0005055 | EFO:0000558 |
| exocrine pancreatic carcinoma | 1 | MONDO:0005192 | EFO:0002618 |
| prostate carcinoma | 1 | MONDO:0005159 | EFO:0001663 |
| gastric neoplasm | 1 | MONDO:0021085 | MONDO:0001056 |
| triple-negative breast carcinoma | 1 | MONDO:0005494 | EFO:0005537 |
| oropharynx cancer | 1 | MONDO:0004608 | EFO:1001931 |
| penile neoplasm | 1 | MONDO:0006895 | MONDO:0001325 |
| vaginal cancer | 1 | MONDO:0001402 | MONDO:0001402 |
| pancreatic neoplasm | 1 | MONDO:0021040 | EFO:0003860 |
5 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 55.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE2 | 21 |
| PHASE1/PHASE2 | 17 |
| PHASE1 | 13 |
| PHASE3 | 2 |
| PHASE2/PHASE3 | 1 |
| Not specified | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT03631706 | PHASE3 | COMPLETED | M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC) |
| NCT04066491 | PHASE2/PHASE3 | TERMINATED | Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC |
| NCT05061823 | PHASE3 | COMPLETED | Bintrafusp Alfa Program Rollover Study |
| NCT04287868 | PHASE1/PHASE2 | ACTIVE_NOT_RECRUITING | Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies |
| NCT04303117 | PHASE1/PHASE2 | RECRUITING | PDS01ADC Monotherapy and in Combination With M7824 in Advanced Kaposi Sarcoma |
| NCT04417660 | PHASE2 | ACTIVE_NOT_RECRUITING | Bintrafusp Alfa (M7824) in Subjects With Thymoma and Thymic Carcinoma |
| NCT04432597 | PHASE1/PHASE2 | ACTIVE_NOT_RECRUITING | HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PDL1/TGF-Beta Trap (M7824) in Subjects With HPV Associated Cancers |
| NCT04633252 | PHASE1/PHASE2 | RECRUITING | A Phase I/II Study of PDS01ADC With Docetaxel and Abiraterone in Adults With Metastatic Castration Sensitive and PDS01ADC With Docetaxel in Castration Resistant Prostate Cancer |
| NCT04708470 | PHASE1/PHASE2 | ACTIVE_NOT_RECRUITING | A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers |
| NCT04874311 | PHASE2 | RECRUITING | Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma |
| NCT03315871 | PHASE2 | COMPLETED | Combination Immunotherapy in Biochemically Recurrent Prostate Cancer |
| NCT03427411 | PHASE2 | COMPLETED | M7824 in Subjects With HPV Associated Malignancies |
| NCT03451773 | PHASE1/PHASE2 | TERMINATED | M7824 (MSB0011359C) in Combination With Gemcitabine in Adults With Previously Treated Advanced Adenocarcinoma of the Pancreas |
| NCT03493945 | PHASE1/PHASE2 | COMPLETED | Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1) |
| NCT03554473 | PHASE1/PHASE2 | COMPLETED | M7824 and Topotecan or Temozolomide in Relapsed Small Cell Lung Cancers |
| NCT03707587 | PHASE2 | COMPLETED | M7824 in People With Recurrent Respiratory Papillomatosis |
| NCT03833661 | PHASE2 | COMPLETED | M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer) |
| NCT03840902 | PHASE2 | TERMINATED | M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) |
| NCT03840915 | PHASE1/PHASE2 | COMPLETED | M7824 in Combination With Chemotherapy in Stage IV Non-small Cell Lung Cancer (NSCLC) |
| NCT04220775 | PHASE1/PHASE2 | TERMINATED | Bintrafusp Alfa and Stereotactic Body Radiation Therapy for the Treatment of Recurrent or Second Primary Head and Neck Squamous Cell Cancer |
| NCT04246489 | PHASE2 | COMPLETED | Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical Cancer |
| NCT04247282 | PHASE1/PHASE2 | COMPLETED | Anti-PD-L1/TGF-beta Trap (M7824) Alone and in Combination With TriAd Vaccine and N-803 for Resectable Head and Neck Squamous Cell Carcinoma Not Associated With Human Papillomavirus Infection |
| NCT04297748 | PHASE1/PHASE2 | TERMINATED | Bioimaging Study of 89Zr-M7824 in NSCLC |
| NCT04327986 | PHASE1/PHASE2 | TERMINATED | Immune Checkpoint Inhibitor M7824 and the Immunocytokine M9241 in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Advanced Pancreas Cancer |
| NCT04396535 | PHASE2 | TERMINATED | Docetaxel With or Without Bintrafusp Alfa for the Treatment of Advanced Non-small Cell Lung Cancer |
| NCT04396886 | PHASE2 | COMPLETED | Bintrafusp Alfa in Previously Treated Patients With R/M Non-keratinizing NPC |
| NCT04428047 | PHASE2 | TERMINATED | Evaluation of Bintrafusp Alfa in Operable and Untreated Head and Neck Squamous Cell Carcinoma |
| NCT04489940 | PHASE2 | TERMINATED | Bintrafusp Alfa in High Mobility Group AT-Hook 2 (HMGA2) Expressing Triple Negative Breast Cancer |
| NCT04491955 | PHASE2 | COMPLETED | Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers |
| NCT04501094 | PHASE2 | TERMINATED | A Phase II Study of Bintrafusp Alfa (M7824) in Checkpoint Inhibitor Naive and Refractory Subjects With Urothelial Carcinoma |
| NCT04560686 | PHASE2 | TERMINATED | Bintrafusp Alfa Before Surgery for the Treatment of Untreated Resectable Non-small Cell Lung Cancer |
| NCT04574583 | PHASE1/PHASE2 | COMPLETED | Phase I/II Trial Investigating the Safety, Tolerability, Pharmacokinetics, Immune and Clinical Activity of SX-682 in Combination With BinTrafusp Alfa (M7824 or TGF-beta Trap/PD-L1) With CV301 TRICOM in Advanced Solid Tumors (STAT) |
| NCT04648826 | PHASE1/PHASE2 | WITHDRAWN | Aerosolized Azacytidine as Epigenetic Priming for Bintrafusp Alfa-Mediated Immune Checkpoint Blockade in Patients With Unresectable Pulmonary Metastases From Sarcomas, Germ Cell Tumors, or Epithelial Malignancies |
| NCT04727541 | PHASE2 | TERMINATED | Neoadjuvant Bintrafusp Alfa in Patients With Resectable Biliary Tract Cancer |
| NCT04789668 | PHASE1/PHASE2 | TERMINATED | Bintrafusp Alfa and Pimasertib for the Treatment of Patients With Brain Metastases |
| NCT04835896 | PHASE1/PHASE2 | COMPLETED | Study of M7824 and Paclitaxel Combination as a Second-line Treatment in Patients With Recurrent/Metastatic Gastric Cancer |
| NCT04878250 | PHASE2 | UNKNOWN | Preoperative Bintrafusp Alfa in Operable Urothelial Carcinoma of the Bladder |
| NCT04971187 | PHASE2 | TERMINATED | Bintrafusp Alfa With Chemotherapy for Tyrosine Kinase Inhibitor-Resistant EGFR-Mutant Non-small Cell Lung Cancer |
| NCT05005429 | PHASE2 | COMPLETED | Study of the Efficacy and Safety of the Bintrafusp Alfa in Previously Treated Advanced Malignant Pleural Mesothelioma |
| NCT05012098 | PHASE2 | COMPLETED | Phase 2 Study of Bintrafusp Alfa in Recurrent/Metastatic Olfactory Neuroblastoma (BARON). |
| NCT05445882 | PHASE2 | WITHDRAWN | N-803 Alone or in Combination With BN-Brachyury Vaccine or Bintrafusp Alfa (M7824) for Participants With Castration Resistant Prostate Cancer |
| NCT04235777 | PHASE1 | RECRUITING | Bintrafusp Alfa (M7824) and PDS01ADC Alone and in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Metastatic Non-Prostate Genitourinary Malignancies |
| NCT04708067 | PHASE1 | ACTIVE_NOT_RECRUITING | Hypofractionated Radiation Therapy and Bintrafusp Alfa for the Treatment of Advanced Intrahepatic Cholangiocarcinoma |
| NCT02517398 | PHASE1 | COMPLETED | MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors |
| NCT02699515 | PHASE1 | COMPLETED | MSB0011359C (M7824) in Participants With Metastatic or Locally Advanced Solid Tumors |
| NCT02723955 | PHASE1 | COMPLETED | Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1) |
| NCT03524170 | PHASE1 | COMPLETED | Radiation Therapy and M7824 in Treating Patients With Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer |
| NCT03579472 | PHASE1 | TERMINATED | M7824 and Eribulin Mesylate in Treating Patients With Metastatic Triple Negative Breast Cancer |
| NCT03620201 | PHASE1 | COMPLETED | M7824 in Treating Patients With Stage II-III HER2 Positive Breast Cancer |
| NCT04296942 | PHASE1 | TERMINATED | BN-Brachyury, Entinostat, Adotrastuzumab Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT) |
| NCT04349280 | PHASE1 | TERMINATED | A Study to Evaluate the Efficacy and Safety of Bintrafusp Alfa (M7824) Monotherapy in Metastatic or Locally Advanced Urothelial Cancer |
| NCT04457778 | PHASE1 | COMPLETED | First in Human Study of M6223 |
| NCT04551950 | PHASE1 | COMPLETED | Bintrafusp Alfa Combination Therapy in Participants With Cervical Cancer (INTR@PID 046) |
| NCT04756505 | PHASE1 | WITHDRAWN | Immunotherapy (NHS-IL12 & Bintrafusp Alfa) and Radiation Therapy for the Treatment of Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer, the REINA Trial |
| NCT04481256 | Not specified | RECRUITING | TGF-β And PDL-1 Inhibition in Esophageal Squamous Cell Carcinoma Combined With Chemoradiation TheRapY |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).
Related Atlas pages
- In clinical trials for: non-small cell lung carcinoma, lung neoplasm, head and neck squamous cell carcinoma, breast carcinoma, cervical adenocarcinoma, breast neoplasm, colorectal adenocarcinoma, cholangiocarcinoma, thymoma, intrahepatic cholangiocarcinoma, carcinoma of esophagus, soft tissue sarcoma, mesothelioma, gallbladder neoplasm