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

Phase 1

Active, not recruiting

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

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.

Other protocol defined inclusion/exclusion criteria could apply

Arm && Interventions

Group	Intervention	Description
BDB018 in Combination with Pembrolizumab	BDB018	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.
BDB018 in Monotherapy	BDB018	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.
BDB018 in Combination with Pembrolizumab	Pembrolizumab	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.

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability: incidence of adverse events and any dose limiting toxicity	Up to 30 months	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

Secondary Outcome Measures

Name	Time	Method
Determine Maximum Tolerated Dose	From first dose to 21 days after first dose for each patient (cycle 1)	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
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)	Radiographic determination of tumor response in subjects dosed with BDB018 and BDB018 and pembrolizumab combination therapy using irRECIST

Locations (3): START MidWest
🇺🇸
Grand Rapids, Michigan, United States
Florida Cancer Specialists
🇺🇸
Sarasota, Florida, United States
START
🇺🇸
San Antonio, Texas, United States