What side effects are associated with this type of intervention?

Common side effects of immune checkpoint inhibitors, such as those similar to BI 765179, include cutaneous immune-related adverse events like rash, pruritus (itchiness), and vitiligo. Other frequent side effects are fatigue, diarrhea, and endocrine disorders such as hypothyroidism or hyperthyroidism. Severe but less common side effects can include pneumonitis, hepatitis, colitis, and myocarditis. These treatments can also cause infusion-related reactions and, in some cases, more serious immune-mediated conditions that require prompt medical attention.

What prior FDA approvals exist?

Several antibodies that help the immune system fight cancer have received FDA approval for the treatment of tumors. Notable examples include pembrolizumab and nivolumab, which are PD-1 inhibitors approved for various cancers such as melanoma, non-small cell lung cancer (NSCLC), and renal cell carcinoma. Ipilimumab, a CTLA-4 inhibitor, is approved for melanoma. Atezolizumab, a PD-L1 inhibitor, is approved for NSCLC and other cancers. These drugs work by targeting immune checkpoints, thereby enhancing the immune system's ability to attack cancer cells.

What other types of research exist?

Promising novel alternatives to BI 765179 for tumor patients include: 1) Nivolumab and Pembrolizumab, which are PD-1 inhibitors showing efficacy in various cancers such as non-small cell lung cancer and melanoma. 2) Atezolizumab, a PD-L1 inhibitor used in urothelial carcinoma and non-small cell lung cancer. 3) Ibrutinib, a BTK inhibitor for chronic lymphocytic leukemia. 4) Enfortumab Vedotin, an antibody-drug conjugate for urothelial carcinoma. These treatments have demonstrated significant clinical benefits and are expected to be relevant in 2024.

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Monoclonal Antibodies

BI 765179 + Ezabenlimab for Advanced Cancer

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

Patients with locally advanced, unresectable or metastatic solid tumors who are either refractory after standard therapy for the disease or for whom standard therapy is not appropriate

Tumor with expected high expression of Fibroblast activation protein (FAP) of the following histologies: Non-small cell lung carcinoma (NSCLC), Gastric cancer, Esophageal adenocarcinoma or squamous cell carcinoma, Urothelial bladder carcinoma, Head and neck squamous cell carcinoma, Cutaneous malignant melanoma, Cutaneous squamous cell carcinoma, Hepatocellular carcinoma, Pancreatic adenocarcinoma, Colorectal cancer, Malignant pleural mesothelioma, Cervical squamous cell cancer, Ovarian carcinoma, Triple-negative breast cancer

Must not have

Previous treatment with agents targeting CD137

Known leptomeningeal disease or spinal cord compression due to disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new medicine called BI 765179, alone or with ezabenlimab, for adults with advanced cancer who didn't respond to other treatments. These medicines aim to help the immune system fight cancer. Participants are monitored over several years to see if the treatment helps and is safe.

Who is the study for?

Adults with advanced solid tumors that didn't respond to standard treatments or for whom such treatments aren't suitable can join. This includes those with certain types of cancers like lung, gastric, and breast cancer, among others. Participants must be over 18, have at least one measurable tumor outside the brain, be in good physical condition (ECOG 0 or 1), and have proper organ function. Women who can bear children and men who can father a child must use effective birth control.

What is being tested?

The trial is testing the highest tolerable dose of BI 765179 alone or combined with ezabenlimab in patients with advanced cancer. Both drugs are antibodies designed to help the immune system fight cancer; this is the first time BI 765179 is being used on people. Treatments are given via infusion every three weeks for up to three years if beneficial and tolerable.

What are the potential side effects?

While specific side effects aren't listed here, participants will be monitored regularly for any health problems related to treatment which could include typical antibody-related reactions like immune system complications, infusion reactions, fatigue or allergic responses.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is advanced and hasn't responded to standard treatments, or standard treatments aren't suitable for me.

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My cancer is expected to have high FAP expression.

Select...

I am at least 18 years old or the legal age of consent in my country.

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I have a tumor outside the brain that can be measured.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am using or willing to use effective birth control during and 6 months after the study.

Exclusion Criteria

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

Select...

I have been treated with drugs targeting CD137 before.

Select...

My cancer has spread to the lining of my brain or spinal cord.

Select...

I have been diagnosed with an immune system disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years.

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

Treatment Details

Study Objectives

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

Primary study objectives

Phase 1a: Maximum Tolerated Dose (MTD)

Phase 1b: Objective response (OR)

Secondary study objectives

Phase 1b: DoR assessed by iRECIST

Phase 1b: OR assessed by the Investigator according to immune-related RECIST (iRECIST)

Phase 1b: OS rate at 12 months

+5 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Placebo + CRT Followed by Placebo

Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Phase 1b Cohort 2: pembrolizumab + high dose of BI 765179Experimental Treatment2 Interventions

Group II: Phase 1b Cohort 1: pembrolizumab + low dose of BI 765179Experimental Treatment2 Interventions

Group III: Phase 1a Arm B: BI 765179 + ezabenlimabExperimental Treatment2 Interventions

Group IV: Phase 1 Arm A: BI 765179Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

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

Immunotherapies, such as BI 765179, work by enhancing the body's immune system to recognize and attack cancer cells. These treatments often involve antibodies that target specific proteins on the surface of cancer cells or immune cells, thereby boosting the immune response against the tumor. This approach is crucial for tumor patients because it offers a targeted method to combat cancer, potentially leading to fewer side effects compared to traditional therapies like chemotherapy. By harnessing the body's natural defenses, immunotherapies can provide a more effective and personalized treatment option for patients with advanced cancers.