Description:
A Phase 1 Open-label Dose Escalation Trial of BDB018 in Monotherapy and in Combination with
Pembrolizumab in Subjects with Advanced Solid Tumors
Title
- Brief Title: 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
Clinical Trial IDs
- ORG STUDY ID:
BDB018-101
- NCT ID:
NCT04840394
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| BDB018 | | BDB018 in Combination with Pembrolizumab |
| Pembrolizumab | | BDB018 in Combination with Pembrolizumab |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| BDB018 in Monotherapy | Experimental | 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 | Experimental | 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. | |
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Safety and Tolerability: incidence of adverse events and any dose limiting toxicity |
| Time Frame: | Up to 30 months |
| Safety Issue: | |
| Description: | 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
| Measure: | Determine Maximum Tolerated Dose |
| Time Frame: | From first dose to 21 days after first dose for each patient (cycle 1) |
| Safety Issue: | |
| Description: | 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 |
| Measure: | Radiographic Determination of Tumor Response after BDB018 Dosing |
| Time Frame: | Every 63 days (3 cycles) up to 30 months after the first dose for each patient (each cycle is 21 days) |
| Safety Issue: | |
| Description: | Radiographic determination of tumor response in subjects dosed with BDB018 and BDB018 and pembrolizumab combination therapy using irRECIST |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Seven and Eight Biopharmaceuticals Inc |
Trial Keywords
- TLR
- Immuno-oncology
- TLR 7/8 Agonist
Last Updated
August 3, 2021
