BDB001 for Cancer

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BDB001 for individuals with advanced solid tumors that haven't responded to previous therapies targeting the PD-1 or PD-L1 proteins. The researchers aim to assess the effectiveness and safety of BDB001 for patients whose cancer has continued to grow despite other treatments. Those with a doctor-confirmed tumor, such as melanoma or head and neck cancer, and whose cancer has progressed after specific immune therapies, might be suitable for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that BDB001 is likely to be safe for humans?

Research has shown that BDB001 has been tested for safety when used with other cancer treatments. One study combined BDB001 with atezolizumab, a cancer drug, to assess treatment tolerance. Although the study did not provide specific safety numbers, it aimed to evaluate the treatment's safety for patients.

Another study tested BDB001 with pembrolizumab, another cancer drug, focusing on safety and initial reactions to BDB001. Again, no specific safety data was shared, but it contributed to ensuring the treatment's safety.

BDB001 is now in a Phase 2 study, indicating it has passed earlier safety tests. So far, BDB001 appears generally well-tolerated, but further research will help confirm this. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for PD-(L)1 refractory solid tumors, which typically include more chemotherapy or targeted therapies, BDB001 works by a new mechanism. It is an experimental drug that stimulates the immune system differently, aiming to activate the body's innate immunity to better fight cancer cells. Researchers are excited about BDB001 because it offers a novel approach by being administered intravenously as monotherapy, potentially providing an option for patients who have not responded to existing anti-PD-1 or anti-PD-L1 therapies. This new approach might offer hope for improved outcomes in a group of patients with limited options.

What evidence suggests that BDB001 might be an effective treatment for advanced solid tumors?

Research has shown that BDB001, the investigational treatment in this trial, has potential in treating advanced solid tumors. It boosts the immune system, helping it recognize and attack cancer cells. Early results suggest that BDB001 can create a strong immune response and lead to lasting improvements in some patients. Previous patients generally tolerated the treatment well, indicating that side effects were manageable. This suggests that BDB001 might be effective for tumors unresponsive to other treatments. ^{1 2 3 5 6}

Who Is on the Research Team?

Harry Raftopoulos, MD

Principal Investigator

Eikon Therapeutics

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• BDB001

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04819373

A Clinical Study of BDB001 in Patients With PD-(L)1 ... BDB001-201 is a multi-center, open-label, Phase II clinical trial to evaluate the efficacy and safety of BDB001 in the treatment of subjects with advanced solid ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04196530

Open Label Dose Escalation of BDB001 in Combination w ... The primary objectives of this study are to evaluate the safety and tolerability of BDB001 in combination with atezolizumab (Tecentriq) in subjects with ...

3. mycancergenome.org mycancergenome.org/content/clinical_trials/NCT04196530/

Clinical Trial: NCT04196530 - BDB001-102 The primary objectives of this study are to evaluate the safety and tolerability of BDB001 in combination with atezolizumab (Tecentriq) in ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9980677/

Trial watch: Toll-like receptor ligands in cancer therapy - PMC BDB018 is an analog of BDB001 designed to further enhance immune activation against cancer, while maintaining a favorable safety profile.

5. researchgate.net researchgate.net/publication/352072683_BDB001_an_intravenously_administered_toll-like_receptor_7_and_8_TLR78_agonist_in_combination_with_pembrolizumab_in_advanced_solid_tumors_Phase_1_safety_and_efficacy_results

BDB001, an intravenously administered toll-like receptor 7 ... BDB001 monotherapy has demonstrated favorable tolerability and robust systemic immune activation leading to durable clinical responses in a phase I dose ...

6. withpower.com withpower.com/trial/phase-3-7-2021-f4297

A Clinical Study of BDB001 in Patients With PD-(L)1 ... What safety data exists for the treatment BDB001? The available research does not provide specific safety data for BDB001, but it discusses general methods ...