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PD-L1 Inhibitor
BDB001-201: A Clinical Study of BDB001 in Patients With PD-(L)1 Refractory Solid Tumors
Phase 2
Waitlist Available
Research Sponsored by Birdie Biopharmaceuticals HK Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately up to 1.5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests BDB001, a drug that boosts the immune system, in patients with advanced cancers that haven't responded to standard treatments. The drug works by making the immune system more aggressive in attacking cancer cells.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately up to 1.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately up to 1.5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy as measured by Objective Response Rate
Secondary study objectives
Efficacy as measured by Disease Control Rate
Efficacy as measured by Overall Survival (OS)
Efficacy as measured by Progression-Free Survival (PFS)
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: BDB001Experimental Treatment1 Intervention
BDB001 will be administered intravenously as monotherapy in subjects with histologically-confirmed unresectable or metastatic solid tumors that have progressed on anti-PD-1 or anti-PD-L1 mAb treatment either as monotherapy or in combination with other therapies.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BDB001
2021
Completed Phase 2
~10
Find a Location
Who is running the clinical trial?
Birdie Biopharmaceuticals HK LimitedLead Sponsor
2 Previous Clinical Trials
90 Total Patients Enrolled
Seven and Eight Biopharmaceuticals IncIndustry Sponsor
4 Previous Clinical Trials
338 Total Patients Enrolled
Eikon TherapeuticsLead Sponsor
7 Previous Clinical Trials
1,218 Total Patients Enrolled
Robert Andtbacka, MD, CMStudy ChairSeven and Eight Biopharmaceuticals Inc
Harry Raftopoulos, MDStudy ChairEikon Therapeutics
3 Previous Clinical Trials
91 Total Patients Enrolled