BDB001-201: A Clinical Study of BDB001 in Patients With PD-(L)1 Refractory Solid Tumors
- Registration Number
- NCT04819373
- Lead Sponsor
- Eikon Therapeutics
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BDB001 BDB001 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.
- Primary Outcome Measures
Name Time Method Efficacy as measured by Objective Response Rate Approximately up to 2 years Objective Response Rate
- Secondary Outcome Measures
Name Time Method Efficacy as measured by Time-to-Treatment Failure (TTF) Approximately up to 2 years Time-to-Treatment Failure (TTF)
Efficacy as measured by Overall Survival (OS) Approximately up to 2 years Overall Survival (OS)
Efficacy as measured by Disease Control Rate Approximately up to 2 years Disease Control Rate (DCR)
Evaluate Duration of Response (DoR) 3 months through approximately 2 years 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.
Safety and Tolerability of BDB001 Approximately up to 2 years Evaluate Adverse events (AEs) and AEs causing drug discontinuation
Evaluate Biomarkers Approximately up to 1.5 years Evaluate blood samples and tumor biopsy samples for signs of systemic and local immunologic changes by measuring cytokines and transcriptional RNA, and by immunophenotyping.
Efficacy as measured by Progression-Free Survival (PFS) 3 months through approximately 2 years 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.
Efficacy as measured by RECIST 1.1 (ORR, DCR, PFS, and DoR) 3 months through approximately 2 years Evaluate ORR, DCR, PFS, and DoR per RECIST 1.1
Trial Locations
- Locations (1)
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States