Description:
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.
Title
- Brief Title: BDB001-201: A Clinical Study of BDB001 in Patients With PD-(L)1 Refractory Solid Tumors
- 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
Clinical Trial IDs
- ORG STUDY ID:
BDB001-201
- NCT ID:
NCT04819373
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| BDB001 | | BDB001 |
Purpose
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
Trial Arms
| Name | Type | Description | Interventions |
|---|
| BDB001 | Experimental | 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. | |
Eligibility 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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Efficacy as measured by Objective Response Rate |
| Time Frame: | Approximately up to 2 years |
| Safety Issue: | |
| Description: | Objective Response Rate |
Secondary Outcome Measures
| Measure: | Efficacy as measured by Disease Control Rate |
| Time Frame: | Approximately up to 2 years |
| Safety Issue: | |
| Description: | Disease Control Rate (DCR) |
| Measure: | Efficacy as measured by Progression-Free Survival (PFS) |
| Time Frame: | 3 months through approximately 2 years |
| Safety Issue: | |
| Description: | 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. |
| Measure: | Evaluate Duration of Response (DoR) |
| Time Frame: | 3 months through approximately 2 years |
| Safety Issue: | |
| Description: | 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. |
| Measure: | Efficacy as measured by Time-to-Treatment Failure (TTF) |
| Time Frame: | Approximately up to 2 years |
| Safety Issue: | |
| Description: | Time-to-Treatment Failure (TTF) |
| Measure: | Efficacy as measured by Overall Survival (OS) |
| Time Frame: | Approximately up to 2 years |
| Safety Issue: | |
| Description: | Overall Survival (OS) |
| Measure: | Efficacy as measured by RECIST 1.1 (ORR, DCR, PFS, and DoR) |
| Time Frame: | 3 months through approximately 2 years |
| Safety Issue: | |
| Description: | Evaluate ORR, DCR, PFS, and DoR per RECIST 1.1 |
| Measure: | Safety and Tolerability of BDB001 |
| Time Frame: | Approximately up to 2 years |
| Safety Issue: | |
| Description: | Evaluate Adverse events (AEs) and AEs causing drug discontinuation |
| Measure: | Evaluate Biomarkers |
| Time Frame: | Approximately up to 1.5 years |
| Safety Issue: | |
| Description: | Evaluate blood samples and tumor biopsy samples for signs of systemic and local immunologic changes by measuring cytokines and transcriptional RNA, and by immunophenotyping. |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Birdie Biopharmaceuticals HK Limited |
Trial Keywords
Last Updated
August 4, 2021
