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

Tumor, Solid Clinical Trial

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 Details — Status: Completed

Administrative data

• NCT number: NCT04819373
• Other study ID #: BDB001-201
• Status: Completed
• Phase: Phase 2
• Start date: August 30, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: June 2023
• Source: Eikon Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: May 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tumor, Solid

Intervention

Drug:
• BDB001
BDB001 is an immunotherapy agent.

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eikon Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy as measured by Objective Response Rate	Objective Response Rate	Approximately up to 2 years
Secondary	Efficacy as measured by Disease Control Rate	Disease Control Rate (DCR)	Approximately up to 2 years
Secondary	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
Secondary	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
Secondary	Efficacy as measured by Time-to-Treatment Failure (TTF)	Time-to-Treatment Failure (TTF)	Approximately up to 2 years
Secondary	Efficacy as measured by Overall Survival (OS)	Overall Survival (OS)	Approximately up to 2 years
Secondary	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
Secondary	Safety and Tolerability of BDB001	Evaluate Adverse events (AEs) and AEs causing drug discontinuation	Approximately up to 2 years
Secondary	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