BDB001-201: A Clinical Study of BDB001 in Patients With PD-(L)1 Refractory Solid Tumors

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Tumor, Solid

Intervention / Treatment
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* Drug: BDB001


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Participants are eligible to be included in the study only if all of the following criteria apply: 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. Tumor progression on the most recent line of treatment with anti-PD-1 or anti-PD-L1 mAb as monotherapy or in combination. Eastern Cooperative Oncology Group (ECOG) score of 0 - 2 At least 1 lesion with measurable disease at baseline 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: Greater than 4 lines of prior DNA-damaging chemotherapies. Uncontrolled CNS metastases. Active autoimmune disease. Other protocol defined inclusion/exclusion criteria could apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BDB001<br>BDB001 will be administered intravenously 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. | Drug: BDB001<br>* BDB001 is an immunotherapy agent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy as measured by Objective Response Rate | Objective Response Rate | Approximately up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy as measured by Disease Control Rate | Disease Control Rate (DCR) | Approximately up to 2 years | 
| Efficacy as measured by Progression-Free Survival (PFS) | 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. | 3 months through approximately 2 years | 
| Evaluate Duration of Response (DoR) | 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. | 3 months through approximately 2 years | 
| Efficacy as measured by Time-to-Treatment Failure (TTF) | Time-to-Treatment Failure (TTF) | Approximately up to 2 years | 
| Efficacy as measured by Overall Survival (OS) | Overall Survival (OS) | Approximately up to 2 years | 
| Efficacy as measured by RECIST 1.1 (ORR, DCR, PFS, and DoR) | Evaluate ORR, DCR, PFS, and DoR per RECIST 1.1 | 3 months through approximately 2 years | 
| Safety and Tolerability of BDB001 | Evaluate Adverse events (AEs) and AEs causing drug discontinuation | Approximately up to 2 years | 
| Evaluate Biomarkers | Evaluate blood samples and tumor biopsy samples for signs of systemic and local immunologic changes by measuring cytokines and transcriptional RNA, and by immunophenotyping. | Approximately up to 1.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TLR, Immuno-oncology