Pembrolizumab (Keytruda®), Bi-1607, Ipilimumab (Yervoytm, 50 Mg/10 Ml Solution)
Melanoma, Melanoma Metastatic, Melanoma Of Skin, Melanoma Braf V600e/K Mutated, Melanoma Recurrent, Melanoma Stage Iii Or Iv, Melanoma Negative For Braf, Melanoma Negative For Nras, Melanomas, Uveal Melanoma, Metastatic
Phase I/II
Recruiting
Different Doses of BI-1607 in Combination With Pembrolizumab and Ipilimumab, in Participants With Unresectable or Metastatic Melanoma
Dec 16, 2024
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Pembrolizumab, Bi-1910
Non Small Cell Lung Cancer, Solid Tumors, Hepatocellular Carcinoma
Phase I/II
Recruiting
BI-1910 as a Single Agent and in Combination With Pembrolizumab for the Treatment of Advanced Solid Tumors
Dec 18, 2023
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Trastuzumab, Bi-1607
Metastatic Gastric Adenocarcinoma, Her2-Positive Metastatic Breast Cancer, Her2-Positive Breast Cancer, Her2-Positive Gastric Cancer, Metastatic Gastroesophageal Junction Adenocarcinoma
Phase I/II
Terminated
BI-1607 in Combination with Trastuzumab in Subjects with HER2-positive Advanced Solid Tumors
Sep 22, 2022
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Bt-001, Pembrolizumab [Keytruda®]
Non Small Cell Lung Cancer, Triple Negative Breast Cancer, Melanoma, Metastatic Cancer, Merkel Cell Carcinoma, Soft Tissue Sarcoma
Phase I/II
Recruiting
A Clinical Trial Assessing BT-001 Alone and in Combination With Pembrolizumab in Metastatic or Advanced Solid Tumors
Jan 25, 2021
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Bi-1808, Pembrolizumab (Keytruda® ) 25 Mg/Ml Solution For Injection
Ovarian Cancer, Melanoma, Advanced Malignancies, T-Cell Lymphoma
Phase I/II
Recruiting
BI-1808 As a Single Agent and with Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)
Dec 15, 2020
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Bi1206
Solid Tumor, Adult
Phase I/II
Recruiting
A Study of BI-1206 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors (KEYNOTE-A04)
Oct 21, 2019
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Rituximab, Acalabrutinib, Bi-1206
Indolent B-Cell Non-Hodgkin Lymphoma
Phase I/II
Recruiting
A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL
May 17, 2018
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Bi-505, High Dose Melphalan, Autologous Stem Cell Transplantation
Multiple Myeloma
Phase I/II
Terminated
A Phase I/II Study of BI-505 in Conjunction With Autologous Stem Cell Transplant in Multiple Myeloma
Apr 18, 2016
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Bi-505
Smoldering Multiple Myeloma
Phase II
Terminated
A Phase II Study of BI-505 in Smoldering Multiple Myeloma
Mar 26, 2013
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Mldl1278a, Statin, Stable Dose
Atherosclerosis
Phase II
Completed
A Study to Evaluate the Safety, Tolerability, and Activity of Intravenous MLDL1278A in Patients on Standard-of-Care Therapy for Stable Atherosclerotic Cardiovascular Disease (GLACIER)
Dec 10, 2010
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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 BioInvent International AB (BIX0) have in its pipeline
BIX0 is currently developing the following drugs: Pembrolizumab (Keytruda®), Bi-1607, Ipilimumab (Yervoytm, 50 Mg/10 Ml Solution), Pembrolizumab, Bi-1910, Trastuzumab, Bi-1607. These drug candidates are in various stages of clinical development as the company works toward FDA approval.