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

• Sponsor: Birdie Biopharmaceuticals HK Limited (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04819373
• Collaborator: Seven and Eight Biopharmaceuticals Inc (Industry)
• Enrollment: 100
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 16.1
• Patients Per Site: 50
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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

• Study Type: Interventional
• Anticipated 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: Aug 30, 2021
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

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

Primary Outcome Measures

1. Efficacy as measured by Objective Response Rate [Approximately up to 2 years]

   Objective Response Rate

Secondary Outcome Measures

1. Efficacy as measured by Disease Control Rate [Approximately up to 2 years]

   Disease Control Rate (DCR)

2. 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.

3. 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.

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

   Time-to-Treatment Failure (TTF)

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

   Overall Survival (OS)

6. 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

7. Safety and Tolerability of BDB001 [Approximately up to 2 years]

   Evaluate Adverse events (AEs) and AEs causing drug discontinuation

8. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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/exclusion criteria could apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Morristown Medical Center	Morristown	New Jersey	United States	07960
2	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• Birdie Biopharmaceuticals HK Limited
• Seven and Eight Biopharmaceuticals Inc

Investigators

• Study Chair: Robert Andtbacka, MD, CM, Seven and Eight Biopharmaceuticals Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Birdie Biopharmaceuticals HK Limited
• ClinicalTrials.gov Identifier: NCT04819373
• Other Study ID Numbers: BDB001-201
• First Posted: Mar 29, 2021
• Last Update Posted: Nov 10, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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

Study Results

No Results Posted as of Nov 10, 2021