What side effects are associated with this type of intervention?

Treatments for solid tumors involving immune system modulation and immune checkpoint inhibition, such as BI 1831169 and ezabenlimab, commonly cause side effects like fatigue, rash, diarrhea, and pruritus. More severe but less frequent side effects include pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. These adverse events result from the immune system attacking normal tissues and require careful monitoring and management, often with immunosuppressive therapies.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of solid tumors that involve immune system modulation and immune checkpoint inhibition. Notable examples include Pembrolizumab and Nivolumab, both of which are PD-1 inhibitors used in various cancers such as melanoma, non-small cell lung cancer, and head and neck cancer. Ipilimumab, a CTLA-4 inhibitor, is another approved drug for melanoma. These treatments work by enhancing the body's immune response against cancer cells, similar to the investigational drugs BI 1831169 and Ezabenlimab being studied for their potential to help the immune system fight cancer.

What other types of research exist?

Promising alternatives to BI 1831169 and Ezabenlimab for solid tumor patients include Pembrolizumab and Nivolumab, both of which are immune checkpoint inhibitors. Pembrolizumab has shown efficacy in various cancers, including melanoma and non-small cell lung cancer, while Nivolumab has been effective in melanoma, renal cell carcinoma, and non-small cell lung cancer. Additionally, combination therapies such as Pembrolizumab with chemotherapy or Nivolumab with Ipilimumab are also promising options.

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Monoclonal Antibodies

BI 1831169 + Ezabenlimab for Advanced Cancers

Phase 1

Recruiting

Research Sponsored by Boehringer Ingelheim

Eligibility Criteria Checklist

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

Must have

Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic or relapsed/refractory solid tumor

If only one accessible lesion is available, this lesion must have a minimum lesion diameter of ≥10mm for injection of BI 1831169 and be amenable to biopsy

Must not have

Patients with history of human immunodeficiency virus (HIV) infection who meet one or more of the following criteria

Not receiving antiretroviral therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 49 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is for adults with advanced cancers that can be injected and who have no other treatment options. It tests a new medicine, BI 1831169, alone and with another medicine, ezabenlimab, to see if they can help the immune system fight cancer. The study aims to find the highest safe doses and check if the medicines can shrink tumors.

Who is the study for?

Adults with advanced solid tumors that haven't responded to previous treatments or have no other options can join. They need at least one tumor suitable for injection and biopsy, be over 18 years old, in good health for trial procedures, have a performance status of 0 or 1, and proper organ function. Patients must not have had recent radiation to the target lesions or suffer from conditions like uncontrolled HIV/AIDS.

What is being tested?

The study is testing BI 1831169 alone and combined with ezabenlimab on different types of advanced cancers. Part one determines the highest tolerable dose of BI 1831169; part two does the same for its combination with ezabenlimab. Treatments are given every three weeks via injection into the tumor or infusion into a vein.

What are the potential side effects?

Potential side effects include typical immune-related reactions such as inflammation in various organs due to an activated immune system fighting cancer cells, possible allergic responses to treatment components, fatigue from body's response to therapy, and infection risks.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is advanced, cannot be surgically removed, and has either spread or not responded to treatment.

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I have a tumor that is at least 10mm wide and can be biopsied.

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I have two tumors that can be biopsied; one is at least 10mm wide.

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I am fully active or have some restrictions but can still care for myself.

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My liver function tests are within the required limits.

Exclusion Criteria

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

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I have HIV and meet specific health criteria.

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I am not on antiretroviral therapy.

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I have brain tumors or cancer spread to the brain, confirmed by recent scans.

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I do not have an active infection needing treatment when the trial starts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 49 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 49 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 49 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Part 1.1, Dose escalation/Confirmation: Occurrence of Dose limiting toxicities (DLTs) during the mono Maximum tolerated dose (MTD) evaluation period

Part 1.2, Dose expansion: Objective response (OR) defined as best overall response (BOR) of confirmed intratumoral immunotherapy complete response (itCR) or confirmed intratumoral immunotherapy partial response (itPR)

Part 2.1, Dose escalation/Confirmation: Occurrence of Dose limiting toxicities (DLTs) during the combination Maximum tolerated dose (MTD) evaluation period

+2 more

Secondary study objectives

Part 2.2 - Dose Expansion by Indication, Arm D: Duration of objective response (DoR)

Part 2.2, Dose Expansion by Indication, Arm D: Disease control (DC)

Part 2.2, Dose Expansion by Indication, Arm E: Progression-Free Survival (PFS) rate at 4 months

+2 more

Side effects data

From 2021 Phase 2 trial • 22 Patients • NCT03019640

100%

Anemia

100%

Neutrophil count decreased

100%

White blood cell decreased

100%

Nausea

100%

Fever

100%

Lymphocyte count decreased

100%

Platelet count decreased

95%

Diarrhea

82%

Hyperglycemia

77%

Mucositis oral

77%

Fatigue

64%

Sinus tachycardia

59%

Anorexia

59%

Hypotension

55%

Constipation

55%

Edema limbs

55%

Rash maculo-papular

55%

Hypophosphatemia

50%

Headache

45%

Alanine aminotransferase increased

45%

Hypoalbuminemia

45%

Hypocalcemia

41%

Dizziness

41%

Hypokalemia

36%

Anxiety

36%

Hyponatremia

32%

Vomiting

32%

Hypertension

32%

Cough

32%

Chills

32%

Insomnia

32%

Investigations

32%

Febrile neutropenia

27%

Aspartate aminotransferase increased

27%

Alkaline phosphatase increased

27%

Pain

23%

Arthralgia

23%

Hiccups

23%

Dysphagia

23%

Esophagitis

23%

Hypomagnesemia

23%

Infections and infestations

18%

Hemorrhoids

18%

Abdominal pain

18%

Allergic rhinitis

18%

Dehydration

18%

Dyspnea

18%

Generalized muscle weakness

18%

Hypoxia

14%

Bloating

14%

Hypermagnesemia

14%

Dyspepsia

14%

Paresthesia

14%

Rectal pain

14%

Infusion related reaction

14%

Immune system disorders

14%

INR increased

14%

Pleural effusion

Back pain

Renal and urinary disorders

Hypernatremia

Arthritis

Blood bilirubin increased

Upper respiratory infection

Sore throat

Bone pain

Creatinine increased

Skin ulceration

Cholesterol high

Dry skin

Dysgeusia

Flushing

Non-cardiac chest pain

General disorders and administration site conditions

Hyperuricemia

Nasal congestion

Papulopustular rash

Hypercalcemia

Skin hyperpigmentation

Thromboembolic event

Bladder infection

Gastrointestinal pain

Ear pain

Eye disorders

Nervous system disorders

Tremor

Urinary frequency

Encephalopathy

Respiratory failure

Lung

Atrial fibrillation

Epistaxis

Urinary tract infection

Atelectasis

Rash acneiform

Flatulence

Weight gain

Acute kidney injury

Gastroesophageal reflux disease

Edema face

Endocrine disorders

Metabolism and nutrition disorders

Mucosal infection

Neck pain

Prostatic obstruction

Pulmonary edema

Hematuria

Hemorrhoidal hemorrhage

Hypoglycemia

Musculoskeletal and connective tissue disorder

Myalgia

Hypothyroidism

Lung infection

Lymph node pain

Lymphocyte count increased

Pain in extremity

Peripheral motor neuropathy

Restlessness

Sinus bradycardia

Sinusitis

Skin and subcutaneous tissue disorder

Urinary tract pain

Vascular disorders

Ileus

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Chemotherapy, NK Infusion, Stem Cell Transplant)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

7Treatment groups

Experimental Treatment

Group I: Part 2 (Combination therapy): Arm GExperimental Treatment2 Interventions

Group II: Part 2 (Combination therapy): Arm FExperimental Treatment2 Interventions

Arm F: i.t.+i.v. administration

Group III: Part 2 (Combination therapy): Arm EExperimental Treatment2 Interventions

Arm E: Intravenous (i.v.) administration

Group IV: Part 2 (Combination therapy): Arm DExperimental Treatment2 Interventions

Arm D: Intratumoral (i.t.) administration

Group V: Part 1 (Monotherapy): Arm CExperimental Treatment1 Intervention

Arm C: i.t.+i.v. administration

Group VI: Part 1 (Monotherapy): Arm BExperimental Treatment1 Intervention

Arm B: Intravenous (i.v.) administration

Group VII: Part 1 (Monotherapy): Arm AExperimental Treatment1 Intervention

Arm A: Intratumoral (i.t.) administration

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

anti-PD-1 antibody

2017

Completed Phase 2

~120

0 / 9Eligibility 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

The most common treatments for solid tumors often involve immune system modulation and immune checkpoint inhibition. Immune system modulation, as seen with BI 1831169, aims to enhance the body's immune response against cancer cells by activating immune cells directly within the tumor environment. Immune checkpoint inhibitors, like ezabenlimab, work by blocking proteins that prevent immune cells from attacking cancer cells, thereby allowing the immune system to recognize and destroy these cells more effectively. These mechanisms are crucial for solid tumor patients because they offer a targeted approach to treatment, potentially leading to better outcomes with fewer side effects compared to traditional therapies like chemotherapy. By harnessing the body's own immune system, these treatments can provide a more personalized and effective cancer therapy.

Radiofrequency ablation of liver metastasis: potential impact on immune checkpoint inhibitor therapy.Recurrent glioma clinical trial, CheckMate-143: the game is not over yet.