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

NCT04819373 | Completed Phase 2 FDA Drug

• 1 other identifier: BDB001-201
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Tumor, Solid

Keywords

TLR, Immuno-oncology

Outcome Measures

Primary Outcomes (1)

• Efficacy as measured by Objective Response Rate

  Objective Response Rate

  Approximately up to 2 years

Secondary Outcomes (8)

• Efficacy as measured by Disease Control Rate

  Approximately up to 2 years

• Efficacy as measured by Progression-Free Survival (PFS)

  3 months through approximately 2 years

• Evaluate Duration of Response (DoR)

  3 months through approximately 2 years

• Efficacy as measured by Time-to-Treatment Failure (TTF)

  Approximately up to 2 years

• Efficacy as measured by Overall Survival (OS)

  Approximately up to 2 years

Study Arms (1)

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.

Drug: BDB001

Interventions

BDB001 DRUG

BDB001 is an immunotherapy agent.

BDB001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eikon Therapeutics: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

BDB001

Study Officials

• Harry Raftopoulos, MD

  Eikon Therapeutics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: March 29, 2021
• Study Start: August 30, 2021
• Primary Completion: April 1, 2023
• Study Completion: May 1, 2023
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)