Clinical trial NCT04840394: Clinical Study of BDB018: Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tumor, Solid
Keywords: TLR7/8
Immuno-oncology
TLR 7/8 Agonist
EIK1001
Lead sponsor: Eikon Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2021-04-12
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety and Tolerability: incidence of adverse events and any dose limiting toxicity
timeFrame: Up to 30 months
Secondary outcomes:
measure: Determine Maximum Tolerated Dose
timeFrame: From first dose to 21 days after first dose for each patient (cycle 1)
measure: Radiographic Determination of Tumor Response after BDB018 Dosing
timeFrame: Every 63 days (3 cycles) up to 30 months after the first dose for each patient (each cycle is 21 days)
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Grand Rapids
country: United States
facility: START MidWest
state: Michigan
city: San Antonio
country: United States
facility: START
state: Texas
Study officials:
affiliation: Eikon Therapeutics
name: Harry Raftopoulos, MD
role: STUDY_CHAIR
References: