Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BDB018 · 1 trial · 1 indication
Safety and tolerability of BDB018 in monotherapy and in combination with pembrolizumab as measured by the incidence of adverse events and any dose limiting toxicity
| Arm | Type | Description |
|---|---|---|
| BDB018 in Monotherapy | EXPERIMENTAL | A single subject will be enrolled at each dose level in the single agent arm. Then dosage escalation will follow a traditional 3+3 dose escalation design. Each successive group of patients will be enrolled at an incrementally higher dosage until the Maximum Tolerable Dose (MTD) or Recommended Phase 2 Dose (RP2D) of single agent BDB018 is reached. |
| BDB018 in Combination with Pembrolizumab | EXPERIMENTAL | In the combination arm of the study, a standard 3+3 dose escalation design will be utilized for all dose levels. When the MTD or RP2D of single agent BDB018 is reached, the first dose level cohort of the combination arm will begin. Once the MTD or RP2D in combination has been determined, approximately twenty additional subjects will be enrolled in the expansion phase of the study. |
| Name | Type | Description |
|---|---|---|
| BDB018 | DRUG | BDB018 is an immunotherapy agent. |
| Pembrolizumab | DRUG | Pembrolizumab is a potent humanized monoclonal antibody with high specificity of binding to the PD 1 receptor. Pembrolizumab has an acceptable preclinical safety profile and is approved as an IV therapy for a variety of advanced malignancies. |
Inclusion Criteria 1. Histologically or cytologically confirmed advanced or metastatic solid tumors that have disease progression after treatment with all available therapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatme...
BDB018 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is being evaluated as a monotherapy and in combination with pembrolizumab in patients with solid tumors. The drug is currently in Phase 1 clinical development.
BDB018 is being developed by Eikon Therapeutics, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the safety and efficacy of BDB018 in patients with advanced solid tumors.
BDB018 is in Phase 1 clinical development. A Phase 1 clinical trial has been completed, which studied the drug as a monotherapy and in combination with pembrolizumab in subjects with advanced solid tumors. The drug is still investigational and not yet approved.
BDB018 has been studied in one clinical trial, identified as NCT04840394. This Phase 1 trial, titled 'Clinical Study of BDB018: Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors,' was conducted in the United States and has been completed.
No, BDB018 is not the same as pembrolizumab. BDB018 is an investigational small molecule being developed by Eikon Therapeutics. Pembrolizumab is a separate, approved immunotherapy drug. In clinical trials, BDB018 is being studied both alone and in combination with pembrolizumab.