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.
Additional locations may be listed on ClinicalTrials.gov for NCT04819373.
See trial information on ClinicalTrials.gov for a list of participating sites.
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
Lead OrganizationEikon Therapeutics
