BDB018 + Pembrolizumab for Advanced Cancer
Trial Summary
What is the purpose of this trial?
This trial is testing a new drug called BDB018, both by itself and with another drug called pembrolizumab. It aims to help patients with advanced cancers that don't respond to other treatments. BDB018 works by boosting the immune system to better attack cancer cells. Pembrolizumab is a humanized antibody approved for the treatment of various types of cancer.
Research Team
Harry Raftopoulos, MD
Principal Investigator
Eikon Therapeutics
Eligibility Criteria
This trial is for adults with advanced solid tumors that have worsened within the last 3 months despite treatment, or who can't tolerate or refuse standard treatments. They must have measurable disease and not have been treated with TLR7, TLR8, dual agonists, or TLR9 agonists before.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive BDB018 in monotherapy or in combination with pembrolizumab following a 3+3 dose escalation design to determine the Maximum Tolerable Dose (MTD) or Recommended Phase 2 Dose (RP2D)
Dose Expansion
Approximately twenty additional subjects are enrolled to further evaluate the safety and efficacy of BDB018 in combination with pembrolizumab at the determined MTD or RP2D
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- BDB018
- Pembrolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Seven and Eight Biopharmaceuticals Inc
Lead Sponsor
Eikon Therapeutics
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University