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BerGenBio ASA (BRRGF)
OTHER OTC:BRRGF
Bemcentinib
Acute Myeloid Leukemia, Non-small Cell Lung Cancer, Glioblastoma, Myelodysplastic Syndromes, Metastatic Melanoma, Metastatic Pancreatic Cancer, Covid-19, Malignant Mesothelioma
Phase I
Completed
A Study to Investigate 14C-bemcentinib in Healthy Male Subjects
Jun 17, 2024
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Carboplatin, Pembrolizumab, Pemetrexed, Bemcentinib
Carcinoma, Non-small-cell Lung
Phase I/II
Terminated
A Clinical Study of Bemcentinib With Standard of Care Chemoimmunotherapy in Untreated Advanced/Metastatic Non-small Cell Lung Cancer Patients With a Mutation in the STK11 Gene
Jul 19, 2022
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Tilvestamab
Ovarian Neoplasms
Phase I
Terminated
A Study of Tilvestamab (BGB149) in Relapsed, Platinum-resistant, High-grade Serous Ovarian Cancer (HGSOC) Participants
May 17, 2021
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Soc, Bemcentinib
Covid-19
Phase II
Completed
A Study of Bemcentinib for the Treatment of COVID-19 in Hospitalised Patients
May 17, 2021
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Bgb149
Healthy Volunteers
Early Phase I
Completed
A First-time-in-human Study of BGB149
Nov 23, 2018
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Bemcentinib; Pembrolizumab
Triple Negative Breast Cancer, Inflammatory Breast Cancer Stage Iv
Phase II
Terminated
Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With TNBC
May 30, 2017
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Bemcentinib; Pembrolizumab
Lung Cancer Metastatic, Nsclc Stage Iv, Adenocarcinoma Of Lung
Phase II
Completed
Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With Advanced NSCLC
May 30, 2017
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Cytarabine, Decitabine, Bemcentinib
Acute Myeloid Leukemia, Myelodysplastic Syndromes
Phase I/II
Completed
A Phase Ib/II Multicenter Open-label Study of Bemcentinib (BGB324) in Patients With AML or MDS
Apr 23, 2015
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Erlotinib, Bemcentinib
Non-small Cell Lung Cancer
Phase I/II
Completed
A Study of BGB324 (Bemcentinib) in Combination With Erlotinib in Patients With Non-Small Cell Lung Cancer
Apr 09, 2015
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does BerGenBio ASA (BRRGF) have in its pipeline
BRRGF is currently developing the following drugs: Bemcentinib, Carboplatin, Pembrolizumab, Pemetrexed, Bemcentinib, Tilvestamab. These drug candidates are in various stages of clinical development as the company works toward FDA approval.