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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04819373
Recruitment Status : Active, not recruiting
First Posted : March 29, 2021
Last Update Posted : November 10, 2021
Sponsor:
Collaborator:
Seven and Eight Biopharmaceuticals Inc
Information provided by (Responsible Party):
Birdie Biopharmaceuticals HK Limited

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tumor, Solid Drug: BDB001 Phase 2

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Arms and Interventions
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Arm Intervention/treatment
Experimental: BDB001
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
BDB001 is an immunotherapy agent.


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy as measured by Objective Response Rate [ Time Frame: Approximately up to 2 years ]
    Objective Response Rate


Secondary Outcome Measures :
  1. Efficacy as measured by Disease Control Rate [ Time Frame: Approximately up to 2 years ]
    Disease Control Rate (DCR)

  2. 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.

  3. 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.

  4. Efficacy as measured by Time-to-Treatment Failure (TTF) [ Time Frame: Approximately up to 2 years ]
    Time-to-Treatment Failure (TTF)

  5. Efficacy as measured by Overall Survival (OS) [ Time Frame: Approximately up to 2 years ]
    Overall Survival (OS)

  6. 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

  7. Safety and Tolerability of BDB001 [ Time Frame: Approximately up to 2 years ]
    Evaluate Adverse events (AEs) and AEs causing drug discontinuation

  8. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Birdie Biopharmaceuticals HK Limited
Seven and Eight Biopharmaceuticals Inc
Investigators
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Study Chair: Robert Andtbacka, MD, CM Seven and Eight Biopharmaceuticals Inc
More Information
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Responsible Party: Birdie Biopharmaceuticals HK Limited
ClinicalTrials.gov Identifier: NCT04819373    
Other Study ID Numbers: BDB001-201
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Birdie Biopharmaceuticals HK Limited:
TLR, Immuno-oncology