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Black Diamond Therapeutics (BDTX) Drug Pipeline
| Drug Name | Condition | Stage | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Temozolomide (Tmz), Silevertinib In Combination With Temozolomide | Central Nervous System Diseases, Glioma, Gbm, Brain Cancer, Newly Diagnosed Glioblastoma, Glioblastoma Multiforme (Gbm), Glioblastoma (Gbm) | Phase II | Not Yet Recruiting | Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII | Jan 07, 2026 | ― |
| Silevertinib (Bdtx-1535) Monotherapy | 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, Advanced Lung Carcinoma, Non-small Cell Lung Cancer, Nsclc | phase1AndPhase2 | 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 | ― |
| 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 | ― |
| Drug Name | Stage | Condition | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Temozolomide (Tmz), Silevertinib In Combination With Temozolomide | Phase II | Central Nervous System Diseases, Glioma, Gbm, Brain Cancer, Newly Diagnosed Glioblastoma, Glioblastoma Multiforme (Gbm), Glioblastoma (Gbm) | Not Yet Recruiting | Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII | Jan 07, 2026 | ― |
| Silevertinib (Bdtx-1535) Monotherapy | phase1AndPhase2 | 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, Advanced Lung Carcinoma, Non-small Cell Lung Cancer, Nsclc | 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 | ― |
| Bdtx-189 | Phase I | Solid Tumor | Terminated | A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Solid Tumors. | Dec 19, 2019 | ― |
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
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
Black Diamond Therapeutics BDTX is currently developing the following drugs: Temozolomide (Tmz), Silevertinib In Combination With Temozolomide, Silevertinib (Bdtx-1535) Monotherapy, Bdtx-189. These drug candidates are in various stages of clinical development as the company works toward FDA approval.