Clinical trial NCT04819373: BDB001-201: A Clinical Study of BDB001 in Patients With PD-(L)1 Refractory Solid Tumors
Official title: A Phase 2, Open-label, Multi-Arm 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tumor, Solid
Keywords: TLR, Immuno-oncology
Lead sponsor: Eikon Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-03-29
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:

1. Histologically or cytologically confirmed: Cutaneous SCC, Head and Neck SCC, Melanoma, Merkel Cell Carcinoma, NSCLC, Renal Cell Carcinoma, or Urothelial Carcinoma. Other tumor types will be allowed at Sponsor's discretion.
2. Tumor progression on the most recent line of treatment with anti-PD-1 or anti-PD-L1 mAb as monotherapy or in combination.
3. Eastern Cooperative Oncology Group (ECOG) score of 0 - 2
4. At least 1 lesion with measurable disease at baseline
5. Availability of a lesion for biopsy and consent to allow pre-treatment tumor biopsy.

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

1. Greater than 4 lines of prior DNA-damaging chemotherapies.
2. Uncontrolled CNS metastases.
3. Active autoimmune disease.

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Efficacy as measured by Objective Response Rate
timeFrame: Approximately up to 2 years
Secondary outcomes:
measure: Efficacy as measured by Disease Control Rate
timeFrame: Approximately up to 2 years
measure: Efficacy as measured by Progression-Free Survival (PFS)
timeFrame: 3 months through approximately 2 years
measure: Evaluate Duration of Response (DoR)
timeFrame: 3 months through approximately 2 years
measure: Efficacy as measured by Time-to-Treatment Failure (TTF)
timeFrame: Approximately up to 2 years
measure: Efficacy as measured by Overall Survival (OS)
timeFrame: Approximately up to 2 years
measure: Efficacy as measured by RECIST 1.1 (ORR, DCR, PFS, and DoR)
timeFrame: 3 months through approximately 2 years
measure: Safety and Tolerability of BDB001
timeFrame: Approximately up to 2 years
measure: Evaluate Biomarkers
timeFrame: Approximately up to 1.5 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: Eikon Therapeutics
name: Harry Raftopoulos, MD
role: STUDY_CHAIR
References: