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Black Diamond Therapeutics, Inc. (BDTX)
:BDTX
Silevertinib (Bdtx-1535) Monotherapy
Non-small Cell Lung Cancer, Nsclc, Advanced Lung Carcinoma, Advanced Non-Small Cell Squamous Lung Cancer, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Lung Cancer, Epidermal Growth Factor Receptor C797s, Epidermal Growth Factor Receptor G719x, Egf-R Positive Non-Small Cell Lung Cancer, Egfr-Tki Resistant Mutation
Phase I/II
Active Not Recruiting
Phase 1/2 Study of Silevertinib (BDTX-1535) in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations
Feb 15, 2022
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Bdtx-189
Solid Tumor
Phase I
Terminated
A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Solid Tumors.
Dec 19, 2019
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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 Black Diamond Therapeutics, Inc. (BDTX) have in its pipeline
BDTX is currently developing the following drugs: Silevertinib (Bdtx-1535) Monotherapy, Bdtx-189. These drug candidates are in various stages of clinical development as the company works toward FDA approval.