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BDB001-201 is a multi-center, open-label, Phase II clinical trial to evaluate the efficacy and safety of BDB001 in the treatment of subjects with advanced solid tumors that have progressed on anti-PD-1 or anti-PD-L1 mAb treatment.
BDB001-201 is a multi-center, open-label, multi-arm Phase II study evaluating an experimental immunotherapy drug called BDB001. BDB001 is a Toll-like receptor 7/8 (TLR7/8) agonist delivered intravenously to systemically activate the innate and adaptive immunity in the treatment of various tumors.
The objectives of this study are to evaluate the efficacy, safety and tolerability of intravenous BDB001 administered as monotherapy in subjects with histologically-confirmed unresectable or metastatic solid tumors that have progressed on anti-PD-1 or anti-PD-L1 mAb treatment either as monotherapy or in combination with other therapies.
The following tumor types may be included in the trial: Non-Small Cell Lung Cancer (NSCLC); Cutaneous Squamous Cell Carcinoma (cSCC); Head and Neck Squamous Cell Carcinoma (HNSCC); Melanoma; Merkel Cell Carcinoma (MCC); Renal Cell Carcinoma (RCC); Urothelial Carcinoma; other types of solid tumors at the discretion of the Sponsor. Each tumor type will be analyzed independently
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BDB001 | Experimental | BDB001 will be administered intravenously as monotherapy in subjects with histologically-confirmed unresectable or metastatic solid tumors that have progressed on anti-PD-1 or anti-PD-L1 mAb treatment either as monotherapy or in combination with other therapies. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BDB001 | Drug | BDB001 is an immunotherapy agent. |
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy as measured by Objective Response Rate | Objective Response Rate | Approximately up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy as measured by Disease Control Rate | Disease Control Rate (DCR) | Approximately up to 2 years |
| Efficacy as measured by Progression-Free Survival (PFS) | Progression-Free Survival (PFS): The time from first day of study drug infusion to the first documented disease progression or death due to any cause, whichever occurs first. |
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Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
Other protocol defined inclusion/exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Harry Raftopoulos, MD | Eikon Therapeutics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000719787 | BDB001 |
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| 3 months through approximately 2 years |
| Evaluate Duration of Response (DoR) | Duration of Response (DoR): For subjects who demonstrate CR (Complete Response) or PR (Partial Response) per irRECIST (Immune-related Response Evaluation Criteria In Solid Tumors), DoR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. | 3 months through approximately 2 years |
| Efficacy as measured by Time-to-Treatment Failure (TTF) | Time-to-Treatment Failure (TTF) | Approximately up to 2 years |
| Efficacy as measured by Overall Survival (OS) | Overall Survival (OS) | Approximately up to 2 years |
| Efficacy as measured by RECIST 1.1 (ORR, DCR, PFS, and DoR) | Evaluate ORR, DCR, PFS, and DoR per RECIST 1.1 | 3 months through approximately 2 years |
| Safety and Tolerability of BDB001 | Evaluate Adverse events (AEs) and AEs causing drug discontinuation | Approximately up to 2 years |
| Evaluate Biomarkers | Evaluate blood samples and tumor biopsy samples for signs of systemic and local immunologic changes by measuring cytokines and transcriptional RNA, and by immunophenotyping. | Approximately up to 1.5 years |