MedPath

Bintrafusp alfa

Generic Name
Bintrafusp alfa
Drug Type
Biotech
CAS Number
1918149-01-5
Unique Ingredient Identifier
NW9K8C1JN3
Background

Bintrafusp alfa is under investigation in clinical trial NCT03833661 (M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)).

Hypofractionated Radiation Therapy and Bintrafusp Alfa for the Treatment of Advanced Intrahepatic Cholangiocarcinoma

Phase 1
Active, not recruiting
Conditions
Locally Advanced Intrahepatic Cholangiocarcinoma
Metastatic Intrahepatic Cholangiocarcinoma
Stage III Intrahepatic Cholangiocarcinoma AJCC v8
Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8
Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8
Stage IV Intrahepatic Cholangiocarcinoma AJCC v8
Interventions
Procedure: Biopsy
Radiation: Hypofractionated Radiation Therapy
First Posted Date
2021-01-13
Last Posted Date
2025-03-28
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
15
Registration Number
NCT04708067
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

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

Phase 1
Withdrawn
Conditions
Sarcomas
Melanomas
Germ Cell Tumors
Epithelial Malignancies (Excluding Lung and Renal Cell Carcinomas)
Pulmonary Metastases
Interventions
Device: AeroEclipse II Breath Actuated Nebulizer
First Posted Date
2020-12-02
Last Posted Date
2021-12-17
Lead Sponsor
National Cancer Institute (NCI)
Registration Number
NCT04648826
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

M9241 in Combination With Docetaxel in Adults With Metastatic Castration Sensitive and Castration Resistant Prostate Cancer

Phase 1
Recruiting
Conditions
Cancer Of Prostate
Prostate Neoplasms
Interventions
First Posted Date
2020-11-18
Last Posted Date
2025-05-20
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
86
Registration Number
NCT04633252
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

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)

Phase 1
Completed
Conditions
Solid Tumors
Metastatic Cancer
Interventions
Biological: recombinant fowlpox viral (FPV)-CV301
First Posted Date
2020-10-05
Last Posted Date
2025-02-03
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
12
Registration Number
NCT04574583
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Bintrafusp Alfa Before Surgery for the Treatment of Untreated Resectable Non-small Cell Lung Cancer

Phase 2
Terminated
Conditions
Stage I Lung Cancer AJCC v8
Stage IA1 Lung Cancer AJCC v8
Stage IA2 Lung Cancer AJCC v8
Stage IA3 Lung Cancer AJCC v8
Stage IIIA Lung Cancer AJCC v8
Resectable Lung Non-Small Cell Carcinoma
Stage IIA Lung Cancer AJCC v8
Stage IIIB Lung Cancer AJCC v8
Stage IB Lung Cancer AJCC v8
Stage II Lung Cancer AJCC v8
Interventions
Procedure: Therapeutic Conventional Surgery
First Posted Date
2020-09-23
Last Posted Date
2022-07-28
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
2
Registration Number
NCT04560686
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Bintrafusp Alfa Combination Therapy in Participants With Cervical Cancer (INTR@PID 046)

Phase 1
Completed
Conditions
Cervical Cancer
Interventions
First Posted Date
2020-09-16
Last Posted Date
2024-03-08
Lead Sponsor
EMD Serono Research & Development Institute, Inc.
Target Recruit Count
25
Registration Number
NCT04551950
Locations
🇺🇸

Stanford Health Care Hospital & Clinics, Stanford, California, United States

🇪🇸

Hospital Clinic i Provincial de Barcelona - Servicio de Oncologia, Barcelona, Spain

🇯🇵

Osaka International Cancer Institute, Osaka-shi, Japan

and more 10 locations

Bintrafusp Alfa in High Mobility Group AT-Hook 2 (HMGA2) Expressing Triple Negative Breast Cancer

Phase 2
Terminated
Conditions
Triple Negative Breast Neoplasms
Interventions
First Posted Date
2020-07-28
Last Posted Date
2023-04-10
Lead Sponsor
EMD Serono Research & Development Institute, Inc.
Target Recruit Count
11
Registration Number
NCT04489940
Locations
🇧🇪

UZ Leuven, Leuven, Belgium

🇺🇸

Medical Oncology Hematology Consultants, PA, Helen F. Graham Cancer Center, Suite 3400, Newark, Delaware, United States

🇺🇸

Mayo Clinic-Jacksonville, Jacksonville, Florida, United States

and more 42 locations

TGF-β And PDL-1 Inhibition in Esophageal Squamous Cell Carcinoma Combined With Chemoradiation TheRapY

Not Applicable
Recruiting
Conditions
Oesophageal Cancer
Carcinoma, Squamous Cell
Interventions
Radiation: External beam radiotherapy
First Posted Date
2020-07-22
Last Posted Date
2024-07-26
Lead Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Target Recruit Count
49
Registration Number
NCT04481256
Locations
🇳🇱

Academic Medical Center, Medical Oncology, Amsterdam, Netherlands

First in Human Study of M6223

Phase 1
Completed
Conditions
Metastatic Solid Tumors
Interventions
First Posted Date
2020-07-07
Last Posted Date
2023-12-08
Lead Sponsor
EMD Serono Research & Development Institute, Inc.
Target Recruit Count
58
Registration Number
NCT04457778
Locations
🇺🇸

Sarah Cannon Research Institute, Nashville, Tennessee, United States

🇺🇸

Next Oncology, San Antonio, Texas, United States

🇨🇦

Princess Margaret Cancer Centre, Toronto, Canada

and more 1 locations

HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PDL1/TGF-Beta Trap (M7824) in Subjects With HPV Associated Cancers

Phase 1
Active, not recruiting
Conditions
Oropharyngeal Cancer
Cervical Cancer
HPV Positive Cancer
Anal Cancer
Vulvar, Vaginal, Penile, Rectal Cancer
Interventions
Biological: PRGN-2009 (Phase II)
Biological: PRGN-2009 (Phase I)
Diagnostic Test: MRI
Diagnostic Test: Bone scan
Diagnostic Test: CT scan
Diagnostic Test: Brain CT
Diagnostic Test: Brain MRI
Procedure: Biopsy (Phase I)
Procedure: Biopsy (Phase II)
First Posted Date
2020-06-16
Last Posted Date
2024-12-12
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
39
Registration Number
NCT04432597
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

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