What side effects are associated with this type of intervention?

Common side effects of treatments similar to BJ-005, which involve anti-PD-L1 and TGF-β pathway inhibition, include immune-related adverse events such as rash, pruritus, diarrhea, and pneumonitis. Other potential side effects are fatigue, nausea, and endocrine disorders like hypothyroidism. Severe adverse events can include grade 3 or 4 toxicities such as severe pneumonitis, colitis, and hepatitis. These side effects are consistent with those observed in treatments involving immune checkpoint inhibitors like pembrolizumab and atezolizumab.

What prior FDA approvals exist?

Several FDA-approved treatments for solid tumors and lymphomas target the PD-1/PD-L1 pathway, similar to the anti-PD-L1 component of BJ-005. Notable examples include Pembrolizumab (Keytruda) and Nivolumab (Opdivo), which are approved for various cancers such as non-small cell lung cancer, melanoma, and Hodgkin lymphoma. Atezolizumab (Tecentriq) is another anti-PD-L1 therapy approved for urothelial carcinoma and non-small cell lung cancer. While there are no specific FDA approvals for therapies combining anti-PD-L1 with TGF-β pathway inhibition, these drugs represent the current landscape of immunotherapies targeting the PD-1/PD-L1 axis.

What other types of research exist?

Promising novel alternatives to BJ-005 for solid tumor or lymphoma patients include: 1) Pembrolizumab, a PD-1 inhibitor, which has shown activity in relapsed/refractory classical Hodgkin's lymphoma. 2) Tucatinib, capecitabine, and trastuzumab combination, which has improved progression-free survival and overall survival in HER2-positive metastatic breast cancer with brain metastases. 3) Blinatumomab and inotuzumab ozogamicin (INO), which are being incorporated into induction chemotherapy regimens for acute lymphoblastic leukemia (ALL). 4) Bispecific antibodies such as epcoritamab, mosunetuzumab, and glofitamab, which are being investigated for diffuse large B-cell lymphoma (DLBCL).

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Monoclonal Antibodies

BJ-005 for Solid Cancers and Lymphoma

Phase 1

Waitlist Available

Research Sponsored by BJ Bioscience, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Calculated creatinine clearance (CrCL) > 50 mL/min (Cockroft-Gault Equation)

Histologically or cytologically confirmed advanced solid tumors or lymphoma

Must not have

Severe cardiovascular disease

Active tuberculosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment called BJ-005 in patients with advanced cancers. BJ-005 helps the immune system attack cancer cells and blocks growth signals for these cells. The study aims to see if this treatment is safe and how it behaves in the body.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not fully known since this is a first-in-human study but may include typical reactions to monoclonal antibodies such as infusion-related reactions, immune system effects causing inflammation in organs (like colitis), fatigue, skin rash or allergic responses.

Eligibility Criteria

Inclusion Criteria

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

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

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My cancer diagnosis was confirmed through tissue or cell testing.

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I have recovered from side effects of previous cancer treatments.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious heart condition.

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I have active tuberculosis.

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

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My high blood pressure is not under control.

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I have previously been treated with anti PD-L1 or TGFβRⅡ therapy.

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I am currently being treated for an infection.

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I have had major blood clotting or bleeding issues.

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I have received CAR-T therapy before.

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I have or had an autoimmune disease or inflammatory disorder.

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I have a brain tumor or cancer spread to my brain causing symptoms.

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I haven't had cancer treatment or radiation in the last 4 weeks or within 5 half-lives of the therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm1Experimental Treatment1 Intervention

BJ-005 dose escalation

Group II: Arm 2Experimental Treatment1 Intervention

BJ-005 cohort expansion

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Anti-PD-L1 therapies block the PD-L1 protein on cancer cells, allowing the immune system to recognize and attack these cells more effectively. TGF-β pathway inhibitors target the TGF-β signaling pathway, which is involved in tumor growth and immune evasion, thereby reducing tumor proliferation and enhancing immune response. These mechanisms are important for patients with solid tumors or lymphoma as they offer a targeted approach to improve immune function and inhibit tumor growth, potentially leading to better treatment outcomes.

Expanding Therapeutic Options for Older Adults: Case-Based Updates in Breast and Lung Cancer.Small-Molecule Targets in Immuno-Oncology.Constitutive NF- κ B Activation Underlines Major Mechanism of Drug Resistance in Relapsed Refractory Diffuse Large B Cell Lymphoma.