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PD-L1 Inhibitor

BDB001 for 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
Histologically or cytologically confirmed: Cutaneous SCC, Head and Neck SCC, Melanoma, Merkel Cell Carcinoma, NSCLC, Renal Cell Carcinoma, or Urothelial Carcinoma. Other tumor types will be allowed at Sponsor's discretion.
Tumor progression on the most recent line of treatment with anti-PD-1 or anti-PD-L1 mAb as monotherapy or in combination.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately up to 1.5 years
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is effective and safe in treating subjects with advanced solid tumors that have progressed despite treatment with other drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately up to 1.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately up to 1.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy as measured by Objective Response Rate
Secondary outcome measures
Efficacy as measured by Disease Control Rate
Efficacy as measured by Overall Survival (OS)
Efficacy as measured by Progression-Free Survival (PFS)
+5 more

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
5 Previous Clinical Trials
231 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

BDB001: Is this experimental medication safe for human use?

"BDB001's safety has been partially supported by data, giving it a score of 2."

Answered by AI

Are people being accepted into this clinical trial right now?

"Unfortunately, this study is not presently recruiting patients as noted on clinicaltrials.gov. The trial was first announced on 8/30/2021 and the most recent update was 11/9/2021. There are 472 other trials that might be a better match for those looking to participate in medical research right now."

Answered by AI
~0 spots leftby Mar 2025