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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04840394
Recruitment Status : Recruiting
First Posted : April 12, 2021
Last Update Posted : August 3, 2021
Sponsor:
Information provided by (Responsible Party):
Birdie Biopharmaceuticals HK Limited ( Seven and Eight Biopharmaceuticals Inc )

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

Condition or disease Intervention/treatment Phase
Tumor, Solid Drug: BDB018 Drug: Pembrolizumab Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 22, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BDB018 in Monotherapy

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.

Drug: BDB018
BDB018 is an immunotherapy agent.

Experimental: BDB018 in Combination with 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.

Drug: BDB018
BDB018 is an immunotherapy agent.

Drug: Pembrolizumab
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.




Primary Outcome Measures :
  1. Safety and Tolerability: incidence of adverse events and any dose limiting toxicity [ Time Frame: 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 :
  1. Determine Maximum Tolerated Dose [ Time Frame: 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

  2. 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) ]
    Radiographic determination of tumor response in subjects dosed with BDB018 and BDB018 and pembrolizumab combination therapy using irRECIST



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04840394


Contacts
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Contact: Robert Andtbacka, MD,CM, 18483000086 randtbacka@7and8biopharma.com
Contact: Melissa Harney 18483000086 mharney@7and8biopharma.com

Locations
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United States, Florida
Florida Cancer Specialists Recruiting
Sarasota, Florida, United States, 34230
Contact: Seven and Eight Biopharma    848-300-0086      
Principal Investigator: Manish Patel, MD         
United States, Michigan
START MidWest Recruiting
Grand Rapids, Michigan, United States, 49501
Contact: Seven and Eight Biopharmaceuticals         
Principal Investigator: Manish Sharma, MD         
Sponsors and Collaborators
Seven and Eight Biopharmaceuticals Inc
Investigators
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Study Chair: Robert Andtbacka, MD, CM, Seven and Eight Biopharmaceuticals Inc
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Responsible Party: Seven and Eight Biopharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT04840394    
Other Study ID Numbers: BDB018-101
First Posted: April 12, 2021    Key Record Dates
Last Update Posted: August 3, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Birdie Biopharmaceuticals HK Limited ( Seven and Eight Biopharmaceuticals Inc ):
TLR
Immuno-oncology
TLR 7/8 Agonist
Additional relevant MeSH terms:
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Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents