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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
BDB001 is an immunotherapy agent.
M D Anderson Cancer Center
Houston, Texas, United States
Efficacy as measured by Objective Response Rate
Objective Response Rate
Time frame: Approximately up to 2 years
Efficacy as measured by Disease Control Rate
Disease Control Rate (DCR)
Time frame: 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.
Time frame: 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.
Time frame: 3 months through approximately 2 years
Efficacy as measured by Time-to-Treatment Failure (TTF)
Time-to-Treatment Failure (TTF)
Time frame: Approximately up to 2 years
Efficacy as measured by Overall Survival (OS)
Overall Survival (OS)
Time frame: 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
Time frame: 3 months through approximately 2 years
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Safety and Tolerability of BDB001
Evaluate Adverse events (AEs) and AEs causing drug discontinuation
Time frame: 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.
Time frame: Approximately up to 1.5 years