BDB001-102: Open Label Dose Escalation of BDB001 in Combination w Atezolizumab
- Registration Number
- NCT04196530
- Lead Sponsor
- Eikon Therapeutics
- Brief Summary
A Phase 1 Open-label Dose Escalation Study of BDB001 in Combination with Atezolizumab in Subjects with Advanced Solid Tumors
- Detailed Description
This clinical trial is a study of an experimental drug called BDB001. BDB001 is a Toll-like receptor (TLR) agonist that activates the immune system.
The primary objectives of this study are to evaluate the safety and tolerability of BDB001 in combination with atezolizumab (Tecentriq) in subjects with unresectable or metastatic solid tumors who have relapsed or are refractory to standard treatment or for whom there is no approved therapy.
This is a multi-center, open-label, dose escalation/dose expansion Phase 1 study of BDB001 in combination with atezolizumab.
The study will be conducted in two separate but independent parts: a dose escalation part with BDB001 and atezolizumab and a dose expansion part of BDB001 in combination with atezolizumab.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Escalation of BDB001 with atezolizumab BDB001 (EIK1001) This part of the study 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 BDB001 with atezolizumab is reached. Dose Escalation of BDB001 with atezolizumab Atezolizumab This part of the study 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 BDB001 with atezolizumab is reached. Dose Expansion of BDB001 with atezolizumab BDB001 (EIK1001) At the end of the dose escalation part of the study, the BDB001 dose to be used in combination with atezolizumab in the expansion part of the study will be established after thorough review of all available safety, preliminary efficacy, PK and PD data. A biologically active dose will be selected that is either the MTD, if one was established in the escalation part, or an RP2D if no MTD was established. Approximately 20 additional subjects will initially be enrolled in the dose expansion part. Dose Expansion of BDB001 with atezolizumab Atezolizumab At the end of the dose escalation part of the study, the BDB001 dose to be used in combination with atezolizumab in the expansion part of the study will be established after thorough review of all available safety, preliminary efficacy, PK and PD data. A biologically active dose will be selected that is either the MTD, if one was established in the escalation part, or an RP2D if no MTD was established. Approximately 20 additional subjects will initially be enrolled in the dose expansion part.
- Primary Outcome Measures
Name Time Method Safety and Tolerability: incidence of adverse events and any dose limiting toxicity up to 21 months Safety and tolerability of BDB001 in combination with atezolizumab as measured by the incidence of adverse events and any dose limiting toxicities (DLT)
Determine Maximum Tolerated Dose (MTD) or recommended Phase 2 Dose (RP2D) from first dose to 21 days after first dose for each patient Determination of the MTD or RP2D by assessing the frequency and severity of adverse events related to BDB001 when given in combination with atezolizumab using CTCAE version 5.0 to categorize adverse event severity
- Secondary Outcome Measures
Name Time Method Radiographic Determination of Tumor Response after BDB001 in combination with atezolizumab dosing At the beginning of Cycle 3 (every cycle is 21 days) up to 30 months after the first dose for each patient Radiographic determination of tumor response in subjects dosed with BDB001 and atezolizumab using irRECIST
Trial Locations
- Locations (5)
Tennessee Oncology
🇺🇸Nashville, Tennessee, United States
Angeles Clinic
🇺🇸Los Angeles, California, United States
NEXT Oncology
🇺🇸San Antonio, Texas, United States
South Texas Accelerated Research Therapeutics (START)
🇺🇸San Antonio, Texas, United States
Florida Cancer Specialists
🇺🇸Sarasota, Florida, United States