Tumor, Solid
Conditions
Keywords
TLR, Immuno-oncology
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
Interventions
DRUGBDB001
BDB001 is an immunotherapy agent.
Sponsors
Eikon Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy as measured by Objective Response Rate | Approximately up to 2 years | Objective Response Rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Efficacy as measured by Time-to-Treatment Failure (TTF) | Approximately up to 2 years | Time-to-Treatment Failure (TTF) |
| Efficacy as measured by Disease Control Rate | Approximately up to 2 years | Disease Control Rate (DCR) |
| 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 |
| 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 Overall Survival (OS) | Approximately up to 2 years | Overall Survival (OS) |
Countries
United States
Outcome results
None listed