BDB001-101: Clinical Study of BDB001 as a Mono-therapy or in Combination With Pembrolizumab

Phase 1

Active, not recruiting

Brief Summary: Phase 1 Open-Label Dose Escalation Study of BDB001 as a Single Agent and in combination with Pembrolizumab in Subjects with Advanced Solid Tumors

Detailed Description: This clinical trial is a study of an experimental drug called BDB001. BDB001 is a Toll-like receptor (TLR) agonist that activates the immune system.

The primary objectives of this study are to evaluate the safety and tolerability of BDB001 as a single agent and in combination with pembrolizumab and to determine the maximum tolerated dose (MTD) or the recommended Phase 2 dose (RP2D) when given in combination with pembrolizumab in subjects with advanced solid tumors.

This is a multi-center, open-label, dose escalation/dose expansion Phase 1 study of BDB001 as a single agent and in combination with pembrolizumab in subjects with histologically-confirmed, incurable, unresectable or metastatic solid tumors that have relapsed or are refractory to standard therapies or for whom there is no approved therapy.

The study will be conducted in two separate but independent dose escalation arms: a single agent arm (BDB001 alone) and a combination arm (BDB001 in combination with pembrolizumab).

Participants will be allowed to continue treatment beyond study termination until occurrence of significant treatment-related toxicity, progressive disease or discontinuation criteria are met.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Single Agent BDB001	BDB001	A single subject will be enrolled at each dose level in the single agent arm until any ≥ Grade 2 treatment-emergent adverse event (TEAE) is observed in the first cycle. 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 BDB001 is reached.
BDB001 in Combination with Pembrolizumab	BDB001	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 BDB001 is reached, the first dose level cohort of the combination arm will begin. Once the MTD or RP2D in combination has been determined, twenty additional subjects will be enrolled in the expansion phase of the study.
BDB001 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 BDB001 is reached, the first dose level cohort of the combination arm will begin. Once the MTD or RP2D in combination has been determined, 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 BDB001 as a single agent and in combination with pembrolizumab as measured by the incidence of adverse events and any dose limiting toxicity

Secondary Outcome Measures

Name	Time	Method
Radiographic Determination of Tumor Response after BDB001 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 BDB001 and BDB001 and pembrolizumab using irRECIST
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 BDB001-related and BDB001 and pembrolizumab-related adverse events using CTCAE version 4.03 to categorize adverse event severity

Locations (5): Florida Cancer Specialists
🇺🇸
Sarasota, Florida, United States
Atlantic Health
🇺🇸
Morristown, New Jersey, United States
NEXT Oncology
🇺🇸
San Antonio, Texas, United States
South Texas Accelerated Research Therapeutics (START)
🇺🇸
San Antonio, Texas, United States
Tennessee Oncology
🇺🇸
Nashville, Tennessee, United States