BDB001-102: Open Label Dose Escalation of BDB001 in Combination w Atezolizumab

Conditions

BDB001 (EIK1001) — DRUG
BDB001 (EIK1001) is an immunotherapy agent.
Atezolizumab — DRUG
Atezolizumab is a is a fully humanized, engineered monoclonal antibody of IgG1 isotype against the protein programmed cell death-ligand 1 (PD-L1). Atezolizumab has an acceptable preclinical safety profile and is approved as an IV therapy for a variety of advanced malignancies.

A Phase 1 Open-label Dose Escalation Study of BDB001 in Combination with Atezolizumab in Subjects with Advanced Solid Tumors

Experimental: Dose Escalation of BDB001 with 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.
Experimental: Dose Expansion of BDB001 with 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.

Safety and Tolerability: incidence of adverse events and any dose limiting toxicity [ Time Frame: up to 21 months ]

Facility	City	State	ZIP	Site coordinators
Angeles Clinic	Los Angeles	California	90025	-
Florida Cancer Specialists	Sarasota	Florida	34230	-
Tennessee Oncology	Nashville	Tennessee	37203	-
NEXT Oncology	San Antonio	Texas	78229	-
South Texas Accelerated Research Therapeutics (START)	San Antonio	Texas	78229	-

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