Clinical Study of BDB018: Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

NCT04840394 | Completed Phase 1 FDA Drug

• 2 other identifiers: BDB018-101KEYNOTE-D26
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 3

Brief Summary

A Phase 1 Open-label Dose Escalation Trial of BDB018 in Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

Conditions

Tumor, Solid

Keywords

TLR7/8; Immuno-oncology; TLR 7/8 Agonist; EIK1001

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability: incidence of adverse events and any dose limiting toxicity

  Safety and tolerability of BDB018 in monotherapy and in combination with pembrolizumab as measured by the incidence of adverse events and any dose limiting toxicity

  Up to 30 months

Secondary Outcomes (2)

• Determine Maximum Tolerated Dose

  From first dose to 21 days after first dose for each patient (cycle 1)

• Radiographic Determination of Tumor Response after BDB018 Dosing

  Every 63 days (3 cycles) up to 30 months after the first dose for each patient (each cycle is 21 days)

Study Arms (2)

BDB018 in Monotherapy

EXPERIMENTAL

A single subject will be enrolled at each dose level in the single agent arm. Then dosage escalation will follow a traditional 3+3 dose escalation design. Each successive group of patients will be enrolled at an incrementally higher dosage until the Maximum Tolerable Dose (MTD) or Recommended Phase 2 Dose (RP2D) of single agent BDB018 is reached.

Drug: BDB018

BDB018 in Combination with Pembrolizumab

EXPERIMENTAL

In the combination arm of the study, a standard 3+3 dose escalation design will be utilized for all dose levels. When the MTD or RP2D of single agent BDB018 is reached, the first dose level cohort of the combination arm will begin. Once the MTD or RP2D in combination has been determined, approximately twenty additional subjects will be enrolled in the expansion phase of the study.

Drug: BDB018; Drug: Pembrolizumab

Interventions

BDB018 DRUG

BDB018 is an immunotherapy agent.

BDB018 in Combination with Pembrolizumab; BDB018 in Monotherapy

Pembrolizumab DRUG

Pembrolizumab is a potent humanized monoclonal antibody with high specificity of binding to the PD 1 receptor. Pembrolizumab has an acceptable preclinical safety profile and is approved as an IV therapy for a variety of advanced malignancies.

BDB018 in Combination with Pembrolizumab

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed advanced or metastatic solid tumors that have disease progression after treatment with all available therapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment. Note: there is no limit to the number of prior treatment regimens
• Evidence of progressive disease (PD) within 3 months of signing the informed consent form.
• Have measurable disease

You may not qualify if:

• Has disease that is suitable for local therapy administered with curative intent.
• Prior exposure to TLR7 agonists, TLR8 agonists, TLR 7/8 dual agonists, and TLR9 agonists.

Sponsors & Collaborators

• Eikon Therapeutics: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (3)

Florida Cancer Specialists

Sarasota, Florida, 34230, United States

Location

START MidWest

Grand Rapids, Michigan, 49501, United States

Location

START

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

pembrolizumab

Study Officials

• Harry Raftopoulos, MD

  Eikon Therapeutics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 12, 2021
• Study Start: June 22, 2021
• Primary Completion: March 31, 2024
• Study Completion: September 30, 2024
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)