BJ-005 for Solid Cancers and Lymphoma

Not currently recruiting at 5 trial locations

Overseen By Joe Zhang, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: BJ Bioscience, Inc.

Disqualifiers: CNS tumor, Hypertension, Cardiovascular, Autoimmune, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effects of a new treatment called BJ-005 for individuals with advanced solid tumors or lymphoma. BJ-005 is a medication designed to block specific proteins that may aid cancer growth. The trial consists of two parts: one to determine the optimal dose and another to evaluate its effectiveness in a larger group. Individuals with advanced solid tumors or lymphoma who have not received certain treatments before might be suitable candidates.

As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in humans.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have had anticancer therapy or radiation therapy within 5 half-lives or 4 weeks before joining the study.

Is there any evidence suggesting that BJ-005 is likely to be safe for humans?

Research shows that BJ-005 is undergoing safety testing in people with advanced solid tumors or lymphoma. This study marks the first use of BJ-005 in humans, so detailed safety information remains unavailable. However, treatments in this early phase receive close monitoring to ensure safety and identify any side effects.

BJ-005 combines two treatment types: one that aids the immune system in attacking cancer cells and another that inhibits cancer cell growth. Although it is too early to determine how well participants tolerate BJ-005, researchers are carefully monitoring for any negative effects during the study. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about BJ-005 because it offers a fresh approach to tackling solid cancers and lymphoma. Unlike traditional treatments, which often focus on killing cancer cells with chemotherapy or radiation, BJ-005 targets cancer at a molecular level, potentially reducing side effects. The treatment involves a novel mechanism that escalates doses in Arm 1 for precision targeting and expands cohorts in Arm 2 to enhance effectiveness. This innovative approach could lead to more effective treatments with fewer side effects, making it a promising candidate in the fight against these cancers.

What evidence suggests that BJ-005 might be an effective treatment for solid cancers and lymphoma?

Research shows that BJ-005 could be a promising treatment for advanced solid tumors and lymphoma. BJ-005 is a unique drug that combines a monoclonal antibody, which helps the immune system attack cancer, with a component that connects to TGF-β, a protein that can weaken the immune system. By blocking both PD-L1, which helps cancer hide from the immune system, and TGF-β, BJ-005 may boost the body's ability to fight cancer. Although direct human data on its effectiveness is not yet available, BJ-005 is designed based on well-researched methods that have shown promise in treating cancer. Early studies support the idea that targeting these pathways can help shrink tumors. Participants in this trial will receive BJ-005 in either a dose escalation or cohort expansion format to evaluate its safety and effectiveness. ^{1 3 4 6 7}

Who Is on the Research Team?

Vicky Gao, MD

Principal Investigator

BJ Bioscience, Inc.

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced solid tumors or lymphoma who have recovered from previous cancer treatments. They must be able to consent, have a life expectancy of at least 3 months, and meet certain health criteria like good liver function and no severe heart issues. People with prior PD-L1/TGFβRⅡ treatment, active infections including HIV/HBV/HCV, recent anticancer therapy, pregnancy, autoimmune diseases, or uncontrolled hypertension cannot join.

Inclusion Criteria

My kidney function, measured by creatinine clearance, is good.

Measurable or evaluable disease per RECIST v1.1

My cancer diagnosis was confirmed through tissue or cell testing.

Exclusion Criteria

I have a serious heart condition.

I have active tuberculosis.

I have an active HIV, hepatitis B, or hepatitis C infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of BJ-005 to evaluate safety and tolerability

8-12 weeks

Cohort Expansion

Participants receive BJ-005 at the determined safe dose to further evaluate pharmacokinetics

12-16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BJ-005

Trial Overview The study tests BJ-005 in patients for the first time. It's a Phase 1 trial focusing on safety and how the body processes the drug. BJ-005 is an experimental molecule combining an anti-PD-L1 antibody with part of TGF-β receptor II aimed at treating advanced cancers.

How Is the Trial Designed?

Group I: Arm1 Experimental Treatment 1 Intervention

BJ-005 dose escalation

Group II: Arm 2 Experimental Treatment 1 Intervention

BJ-005 cohort expansion

Who Is Running the Clinical Trial?

BJ Bioscience, Inc.

Lead Sponsor

Trials

2

Recruited

180+

Published Research Related to This Trial

In a phase Ib study involving 18 patients with primary CNS lymphoma (PCNSL), 94% experienced tumor reductions with ibrutinib monotherapy, highlighting its efficacy, especially in patients with specific mutations (CD79B and MYD88) that enhance B cell receptor signaling.

While ibrutinib showed promising results in reducing tumors and enhancing chemotherapy effectiveness, there was an increased risk of aspergillosis, a fungal infection, indicating a potential safety concern linked to impaired fungal immunity due to BTK inhibition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhibition of B Cell Receptor Signaling by Ibrutinib in Primary CNS Lymphoma. Lionakis, MS., Dunleavy, K., Roschewski, M., et al.[2022]

Ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, has shown promising results in early-phase clinical studies for patients with indolent B-cell lymphomas, leading to increased tumor response rates and significant improvements in survival.

The FDA has designated ibrutinib as a 'breakthrough therapy' for treating relapsed or refractory mantle cell lymphoma and Waldenström macroglobulinemia, highlighting its potential as a novel treatment option in these hematological malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ibrutinib and indolent B-cell lymphomas. Akinleye, A., Furqan, M., Adekunle, O.[2021]

Ibrutinib treatment showed a high overall response rate of 75% in patients with relapsed/refractory primary central nervous system lymphoma (PCNSL), with a median progression-free survival of 4 months, indicating its efficacy in this aggressive cancer type.

Genomic analysis revealed that patients with simpler genetic variants and lower tumor mutation burdens (TMB) responded better to ibrutinib, suggesting that genomic profiling could help predict treatment outcomes and tailor therapies for CNS lymphoma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The outcome of ibrutinib-based regimens in relapsed/refractory central nervous system lymphoma and the potential impact of genomic variants. Wang, S., Zhu, Y., Qian, X., et al.[2023]

A combination treatment of temozolomide, etoposide, doxorubicin, dexamethasone, rituximab, and the BTK inhibitor ibrutinib showed promising responses in patients with primary central nervous system lymphoma.

However, this treatment regimen was linked to significant toxicity, including serious infections like pulmonary and cerebral aspergillosis, highlighting the need for careful monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ibrutinib in PCNSL: The Curious Cases of Clinical Responses and Aspergillosis. Grommes, C., Younes, A.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05115292

Study Details | NCT05115292 | A First-in-Human, Phase 1 ... This is a first-in-human, Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of BJ-005 in patients with advanced solid tumor or lymphoma.

2. withpower.com withpower.com/trial/phase-1-lymphoma-9-2021-6f8fa

BJ-005 for Solid Cancers and Lymphoma In a phase Ib study involving 18 patients with primary CNS lymphoma (PCNSL), 94% experienced tumor reductions with ibrutinib monotherapy, highlighting its ...

3. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/lymphoma

Lymphoma Clinical Trials The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of BJ-005 in patients with advanced solid tumor or lymphoma. BJ-005 ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-08023

A First-in-Human, Phase 1 Dose-Escalation and Cohort ... This is a first-in-human, Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of BJ-005 in patients with advanced solid tumor or lymphoma.

5. ashpublications.org ashpublications.org/blood/article/146/15/1824/546454/Preclinical-advances-in-glofitamab-combinations-a

Preclinical advances in glofitamab combinations: a new ... Preclinical and clinical data suggest that combining ADCs with TCEs may improve therapeutic outcomes, as found in multiple myeloma and other R/R ...

6. mayo.edu mayo.edu/research/clinical-trials/cls-20531161

Clinical Trials The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of BJ-005 in patients with advanced solid tumor or ...

7. synapse.patsnap.com synapse.patsnap.com/drug/c670dea7928a45edbc343ad6739e990b

BJ-005 - Drug Targets, Indications, Patents BJ-005: a PDL1 inhibitors, TGF-β inhibitors Drug, Initially developed by BJ Bioscience Inc., Now, its global highest R&D status is Phase 1, Mechanism: PDL1 ...