BDB001-201: A Clinical Study of BDB001 in Patients With PD-(L)1 Refractory Solid Tumors
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|ClinicalTrials.gov Identifier: NCT04819373|
Recruitment Status : Active, not recruiting
First Posted : March 29, 2021
Last Update Posted : November 10, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Tumor, Solid||Drug: BDB001||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||August 30, 2021|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||January 2023|
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.
BDB001 is an immunotherapy agent.
- Efficacy as measured by Objective Response Rate [ Time Frame: Approximately up to 2 years ]Objective Response Rate
- Efficacy as measured by Disease Control Rate [ Time Frame: Approximately up to 2 years ]Disease Control Rate (DCR)
- Efficacy as measured by Progression-Free Survival (PFS) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Approximately up to 2 years ]Time-to-Treatment Failure (TTF)
- Efficacy as measured by Overall Survival (OS) [ Time Frame: Approximately up to 2 years ]Overall Survival (OS)
- Efficacy as measured by RECIST 1.1 (ORR, DCR, PFS, and DoR) [ Time Frame: 3 months through approximately 2 years ]Evaluate ORR, DCR, PFS, and DoR per RECIST 1.1
- Safety and Tolerability of BDB001 [ Time Frame: Approximately up to 2 years ]Evaluate Adverse events (AEs) and AEs causing drug discontinuation
- Evaluate Biomarkers [ Time Frame: 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04819373
|United States, New Jersey|
|Morristown Medical Center|
|Morristown, New Jersey, United States, 07960|
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Robert Andtbacka, MD, CM||Seven and Eight Biopharmaceuticals Inc|
|Responsible Party:||Birdie Biopharmaceuticals HK Limited|
|Other Study ID Numbers:||
|First Posted:||March 29, 2021 Key Record Dates|
|Last Update Posted:||November 10, 2021|
|Last Verified:||November 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|