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

NCT ID: NCT04819373

Last Updated: 2025-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-30
• Study Completion Date: 2023-05-01

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.

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

Conditions

Tumor, Solid

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

BDB001

Intervention Type: DRUG

BDB001 is an immunotherapy agent.

Interventions

BDB001

BDB001 is an immunotherapy agent.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eikon Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harry Raftopoulos, MD

Role: STUDY_CHAIR

Eikon Therapeutics

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

BDB001-201

Identifier Type: -

Identifier Source: org_study_id