BDB018 + Pembrolizumab for Advanced Cancer

Recruiting at 2 trial locations
MH
RA
Overseen ByRobert Andtbacka, MD,CM,
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Seven and Eight Biopharmaceuticals Inc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

HR

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

My cancer can be measured by tests.
My advanced cancer has worsened after all treatments, or I can't tolerate/refuse standard treatments.
Evidence of progressive disease (PD) within 3 months of signing the informed consent form.

Exclusion Criteria

There may be additional requirements for participating in the study that are not listed here.
My condition can be treated with the goal of curing it.
I have been treated with TLR7, TLR8, or TLR9 drugs before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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)

21 days per cycle
Multiple visits per cycle

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

Up to 30 months
Every 63 days (3 cycles)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 30 months

Treatment Details

Interventions

  • BDB018
  • Pembrolizumab
Trial OverviewThe study is testing BDB018 on its own and combined with Pembrolizumab in patients. It's a Phase 1 trial to find out the right dose of BDB018 and see how safe it is when given alone or with Pembrolizumab to people with advanced solid tumors.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: BDB018 in MonotherapyExperimental Treatment1 Intervention
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.
Group II: BDB018 in Combination with PembrolizumabExperimental Treatment2 Interventions
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Seven and Eight Biopharmaceuticals Inc

Lead Sponsor

Trials
5
Recruited
380+

Eikon Therapeutics

Lead Sponsor

Trials
8
Recruited
1,300+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials
4,096
Recruited
5,232,000+
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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

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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