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

Eikon Therapeutics1 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tumor, Solid

Interventions

BDB018DRUG

BDB018 is an immunotherapy agent.

PembrolizumabDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Florida Cancer Specialists

Sarasota, Florida, United States

START MidWest

Grand Rapids, Michigan, United States

START

San Antonio, Texas, United States

Outcomes

Primary Outcomes

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

Time frame: Up to 30 months

Secondary Outcomes

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

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

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

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

Data from ClinicalTrials.gov

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