BDB001-201: A Clinical Study of BDB001 in Patients With PD-(L)1 Refractory Solid Tumors

Recruiting at 2 trial locations

Overseen By Melissa Harney

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Birdie Biopharmaceuticals HK Limited

Must be taking: Anti-PD-1, Anti-PD-L1

Disqualifiers: CNS metastases, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately up to 2 years

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What safety data exists for the treatment BDB001?

The available research does not provide specific safety data for BDB001, but it discusses general methods for evaluating drug safety, such as using databases for adverse drug reactions and modeling approaches to assess potential hazards. ^{1 2 3 4 5}

Research Team

Harry Raftopoulos, MD

Principal Investigator

Eikon Therapeutics

Eligibility Criteria

Inclusion Criteria

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.

Eastern Cooperative Oncology Group (ECOG) score of 0 - 2

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous BDB001 as monotherapy for advanced solid tumors

Approximately up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months through approximately 2 years

Treatment Details

Interventions

• BDB001

Participant Groups

Group I: BDB001 Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Birdie Biopharmaceuticals HK Limited

Lead Sponsor

Trials

3

Recruited

130+

Eikon Therapeutics

Lead Sponsor

Trials

8

Recruited

1,300+

Seven and Eight Biopharmaceuticals Inc

Industry Sponsor

Trials

5

Recruited

380+

Findings from Research

The DIMDI provides comprehensive databases that contain valuable information on adverse drug reactions, which can help healthcare professionals and researchers understand the safety profiles of various medications.

Access to these databases is crucial for monitoring drug safety and improving patient care by identifying potential risks associated with drug treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Information on adverse drug reactions in databases hosted at the German Institute of Medical Documentation and Information (DIMDI)]. Bystrich, E.[2016]

The benchmark dose (BMD) modeling approach provides more detailed insights into dose-response relationships in drug development compared to the traditional no-observed-adverse-effect-level (NOAEL) method, allowing for better hazard characterization.

Using BMD modeling can reduce the need for animal testing by yielding more information from fewer animals and lower doses, making it a promising alternative or complement to the NOAEL approach in assessing potential drug toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benchmark dose-response analyses for multiple endpoints in drug safety evaluation. Vieira Silva, A., Ringblom, J., Moldeus, P., et al.[2021]

The safety of marketed drugs is a significant concern, as some commonly prescribed medications can lead to serious or life-threatening side effects in patients.

The ChEMBL resource will provide a curated drug safety data set, including toxicity classifications and black box warnings, which will be freely available and regularly updated to aid in drug safety research and discovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. Hunter, FMI., Bento, AP., Bosc, N., et al.[2023]

The study analyzed 345,662 spontaneous reports of adverse drug reactions (ADRs) submitted to the German Federal Institute for Drugs and Medical Devices, revealing a steady increase in reports since 1978, primarily due to stricter legal reporting requirements.

The most commonly reported ADRs were linked to drugs for nervous system disorders, with significant differences in reporting patterns between physicians and patients, suggesting a need for better patient education on potential ADRs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequent Adverse Drug Reactions, and Medication Groups under Suspicion. Dubrall, D., Schmid, M., Alešik, E., et al.[2023]

MetaADEDB 2.0 is an updated online database that now includes 744,709 drug-adverse drug event (ADE) associations, representing a 40% increase from its previous version, making it a more comprehensive resource for researchers.

The new version features a user-friendly web interface, enhancing accessibility for drug safety assessments and studies in drug discovery and development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MetaADEDB 2.0: a comprehensive database on adverse drug events. Yu, Z., Wu, Z., Li, W., et al.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Information on adverse drug reactions in databases hosted at the German Institute of Medical Documentation and Information (DIMDI)]. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Benchmark dose-response analyses for multiple endpoints in drug safety evaluation. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Frequent Adverse Drug Reactions, and Medication Groups under Suspicion. [2023]

5. England pubmed.ncbi.nlm.nih.gov

MetaADEDB 2.0: a comprehensive database on adverse drug events. [2021]