What side effects are associated with this type of intervention?

Common treatments for solid tumors, particularly monoclonal antibodies like BI-1206 and immune checkpoint inhibitors such as pembrolizumab, can cause a range of side effects. These include infusion-related reactions (fever, chills, allergic reactions), immune-related adverse events (pneumonitis, colitis, hepatitis, endocrinopathies, skin reactions), and general symptoms like fatigue, rash, and pruritus. Severe immune-mediated reactions may occur and require immunosuppressive therapy.

What prior FDA approvals exist?

The FDA has approved several monoclonal antibodies and immune checkpoint inhibitors for the treatment of solid tumors. Notable examples include pembrolizumab and nivolumab, both anti-PD-1 antibodies, and ipilimumab, an anti-CTLA-4 antibody. These treatments enhance the immune system's ability to target and destroy cancer cells. While specific approvals for monoclonal antibodies targeting CD32b (FcγRIIB) like BI-1206 are not detailed, the use of monoclonal antibodies in cancer therapy is a well-established and evolving field.

What other types of research exist?

Promising novel alternatives to BI-1206 for solid tumor patients include: 1) Pembrolizumab (anti-PD-1 antibody) in combination with other agents such as lenvatinib or axitinib, which have shown efficacy in various solid tumors. 2) Nivolumab (anti-PD-1 antibody) combined with ipilimumab (anti-CTLA-4 antibody), which has demonstrated significant activity in melanoma and renal cell carcinoma. 3) Atezolizumab (anti-PD-L1 antibody) combined with bevacizumab, which has been effective in metastatic renal cell carcinoma. 4) Novel agents targeting specific mutations or pathways, such as dabrafenib and trametinib for BRAF-mutated tumors. These alternatives are in various stages of clinical trials and have shown promising results in treating advanced solid tumors.

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Monoclonal Antibody

BI-1206 + Pembrolizumab for Advanced Cancer

Phase 1 & 2

Recruiting

Led By Carneiro, PhD

Research Sponsored by BioInvent International AB

Eligibility Criteria Checklist

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

Must have

Has an ECOG performance status of 0-1.

Has a histologically confirmed advanced solid tumor. Subjects must have received at least 2 doses of an approved anti-PD-1/L1 mAb, and have documented progression on or within 12 weeks from the last dose of anti-PD-1/L1 mAb.

Must not have

Needs doses of prednisolone >10 mg daily (or equipotent doses of other corticosteroids)

Has cardiac or renal amyloid light-chain (AL) amyloidosis.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests BI-1206 and pembrolizumab in patients with advanced solid tumors who didn't respond well to previous treatments. BI-1206 removes a shield protecting cancer cells, and pembrolizumab boosts the body's natural defenses to fight the cancer.

Who is the study for?

Adults with advanced solid tumors who've had at least two doses of anti-PD-1/L1 therapy and disease progression within 12 weeks after the last dose. They must have measurable disease, a life expectancy over 12 weeks, good organ function, and be able to consent. Exclusions include active brain metastases, severe pneumonitis history, high steroid needs, pregnancy or breastfeeding women, recent major surgery recovery patients, high medical risk due to systemic diseases including infections or graft versus host disease.

What is being tested?

The trial is testing BI-1206 in combination with Pembrolizumab for those whose tumors progressed after anti-PD-1/L1 treatment. It's a Phase 1/2a study focusing on safety and effectiveness across different cohorts based on tumor type and previous treatments.

What are the potential side effects?

Potential side effects may include reactions related to the immune system such as inflammation in various organs (like lungs), infusion-related reactions which can occur during drug administration; fatigue; digestive issues; blood disorders that affect cell counts; increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or can carry out light work.

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My advanced cancer progressed despite receiving at least 2 doses of anti-PD-1/L1 treatment.

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My organ functions are within normal ranges according to recent tests.

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I have received prior anti-PD-1/PD-L1 therapy for my cancer.

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I am 18 years old or older.

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I cannot or choose not to receive standard cancer treatments.

Exclusion Criteria

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

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I need more than 10 mg of prednisolone or a similar medication daily.

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I have AL amyloidosis affecting my heart or kidneys.

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I've had severe side effects from previous immune therapy.

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I have chronic graft versus host disease.

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I am a woman who can become pregnant, am currently pregnant, or am breastfeeding.

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I have HIV or a history of hepatitis B or C, or tested positive for them.

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I am a man whose partner can become pregnant and I've recently had major surgery.

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I have had active tuberculosis in the past.

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I have serious heart problems that are not under control.

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I have not taken immunosuppressive drugs in the last 7 days.

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I am at high risk due to a severe infection being treated with antibiotics, antifungals, or antivirals.

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I have had or currently have lung inflammation treated with steroids.

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I have received an organ or tissue transplant from another person.

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I have cancer that has spread to my brain or spinal cord.

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I still have side effects from cancer treatment that are not mild.

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I have been diagnosed with more than one type of cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determining the MTD of BI-1206 at the same dose level experiencing a BI-1206 or pembrolizumab-related or possibly related dose-limiting toxicity (DLT)

Documenting AEs and SAEs and determining causality in relation to BI-1206 IV or SC and/or pembrolizumab

Secondary study objectives

Evaluation of ADA response to BI-1206 IV or SC

Evaluation of PK parameters for BI-1206 IV and SC.

Measurement of CD32b receptor occupancy on B cells.

Other study objectives

Assessment of best disease responses according to Immunological Response Evaluation Criteria in Solid Tumors (iRECIST).

Evaluate BI-1206 IV or SC and pembrolizumab tumor penetrance in biopsies

Measurement of duration of objective response and objective response rate

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Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: BI-1206 + Pembrolizumab 25mg/mL (MK-3475)Experimental Treatment1 Intervention

BI-1206 administrated either IV or SC + Pembrolizumab 200mg administered IV every third week as a fixed dose will be used.

0 / 22Eligibility 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

Monoclonal antibodies, such as BI-1206 targeting CD32b (FcγRIIB), are a key component in the treatment of solid tumors. These antibodies work by binding to specific antigens on the surface of cancer cells, marking them for destruction by the immune system. In the case of BI-1206, it targets the FcγRIIB receptor, which can modulate immune responses and enhance the efficacy of other immunotherapies like pembrolizumab. This combination can potentially overcome resistance to previous treatments and improve patient outcomes. For solid tumor patients, these therapies are crucial as they offer a targeted approach that can lead to more effective and personalized treatment options, potentially reducing side effects compared to traditional chemotherapy.

Fc-engineered anti-CD40 antibody enhances multiple effector functions and exhibits potent in vitro and in vivo antitumor activity against hematologic malignancies.Fc receptors as targets for immunotherapy.