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NCT Number: NCT04819373

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

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.

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Key information

Conditions

Tumor, Solid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants are eligible to be included in the study only if all of the following criteria apply:

  • 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.
  • Tumor progression on the most recent line of treatment with anti-PD-1 or anti-PD-L1 mAb as monotherapy or in combination.
  • Eastern Cooperative Oncology Group (ECOG) score of 0 - 2
  • At least 1 lesion with measurable disease at baseline
  • 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:

  • Greater than 4 lines of prior DNA-damaging chemotherapies.
  • Uncontrolled CNS metastases.
  • Active autoimmune disease.

Other protocol defined inclusion/exclusion criteria could apply

Treatment and study plan

BDB001

Drug

BDB001 is an immunotherapy agent.

Primary outcomes

  1. Efficacy as measured by Objective Response Rate

    Time frame: Approximately up to 2 years

    Objective Response Rate

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Eikon Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 29, 2021
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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