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

Tumor, Solid Clinical Trial

Official title:

Phase 1 Open-Label Dose Escalation Study of BDB001 as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04840394
• Other study ID #: BDB018-101
• Secondary ID: KEYNOTE-D26
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: June 22, 2021
• Est. completion date: March 2025

Study information

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

Clinical Trial Summary

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

Description:

This clinical trial is a study of an experimental drug called BDB018. BDB018 is a next-generation Toll-like receptor (TLR) 7/8 agonist that activates the immune system.

The primary objectives of this study are to evaluate the safety and tolerability of BDB018 in monotherapy and in combination with pembrolizumab (Keytruda) in subjects with unresectable or metastatic solid tumors that have relapsed or are refractory to standard treatment or for which there is no approved therapy.

This is a multi-center, open-label, dose escalation/dose expansion Phase 1 study of BDB018 in monotherapy and in combination with pembrolizumab.

The study will be conducted in two separate but independent parts: a dose escalation part with BDB018 in monotherapy and in combination with pembrolizumab and a dose expansion part of BDB018 in combination with pembrolizumab.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. 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

2. Evidence of progressive disease (PD) within 3 months of signing the informed consent form.

3. Have measurable disease

Exclusion Criteria:

1. Has disease that is suitable for local therapy administered with curative intent.

2. Prior exposure to TLR7 agonists, TLR8 agonists, TLR 7/8 dual agonists, and TLR9 agonists.

Other protocol defined inclusion/exclusion criteria could apply

Related Conditions & MeSH terms

• Tumor, Solid

Intervention

Drug:
• BDB018
BDB018 is an immunotherapy agent.
• Pembrolizumab
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.

Locations

Country	Name	City	State
United States	START MidWest	Grand Rapids	Michigan
United States	START	San Antonio	Texas
United States	Florida Cancer Specialists	Sarasota	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Eikon Therapeutics	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Determine Maximum Tolerated Dose	Determination of the maximum tolerated dose by assessing the frequency of BDB018 related and BDB018 and pembrolizumab-related adverse events using CTCAE version 5.0 to categorize adverse event severity	From first dose to 21 days after first dose for each patient (cycle 1)
Secondary	Radiographic Determination of Tumor Response after BDB018 Dosing	Radiographic determination of tumor response in subjects dosed with BDB018 and BDB018 and pembrolizumab combination therapy using irRECIST	Every 63 days (3 cycles) up to 30 months after the first dose for each patient (each cycle is 21 days)