What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly those involving PD-L1 inhibitors like FAZ053, include immune checkpoint inhibitors such as pembrolizumab and atezolizumab. Known side effects of these treatments can include fatigue, nausea, diarrhea, rash, and immune-related adverse effects such as pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. These side effects are generally manageable but can be severe in some cases. Other common treatments for breast cancer, such as chemotherapy and targeted therapies, may cause additional side effects like myelosuppression, neuropathy, and alopecia.

What prior FDA approvals exist?

The FDA has approved several PD-L1 inhibitors for the treatment of breast cancer. A notable example is Atezolizumab, which was approved for use in combination with nab-paclitaxel for patients with PD-L1-positive, metastatic triple-negative breast cancer (TNBC). This approval was based on the results of the IMpassion130 trial, which demonstrated a significant improvement in progression-free survival for patients receiving the combination therapy compared to those receiving chemotherapy alone. Other PD-1/PD-L1 inhibitors, such as Pembrolizumab, are also being explored in clinical trials for their efficacy in treating various subtypes of breast cancer.

What other types of research exist?

Promising novel alternatives to FAZ053 for breast cancer patients in 2024 include other PD-L1 inhibitors like Atezolizumab and Durvalumab. Additionally, novel therapies such as PARP inhibitors (e.g., Olaparib), CDK4/6 inhibitors (e.g., Palbociclib), and antibody-drug conjugates (e.g., Trastuzumab Deruxtecan) are showing significant promise. Combination therapies involving immune checkpoint inhibitors with chemotherapy or targeted agents are also being actively explored.

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Monoclonal Antibodies

FAZ053 + PDR001 for Cancer

Phase 1

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Performance Status (PS) ≤ 2:

Be older than 18 years old

Must not have

Presence of symptomatic central nervous system (CNS) metastases or CNS metastases that require local CNS-directed therapy (e.g. radiotherapy or surgery) or increasing doses of corticosteroids within the prior 2 weeks. Patients with treated brain metastases should be neurologically stable (for 4 weeks post-treatment and prior to study enrollment) and off of steroids for at least 2 weeks before administration of any study treatment.

Active infection requiring systemic antibiotic therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 41 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, FAZ053, given through a vein, alone or with another drug, PDR001. It targets adults with serious cancers and works by helping the immune system attack cancer cells.

Who is the study for?

This trial is for adults with advanced solid tumors, including breast cancer and rare cancers like chordoma and alveolar soft part sarcoma. Participants may have had previous treatments but must have progressed despite those or have no standard treatment options available. They should be able to undergo a tumor biopsy and not be on chronic steroids or immunosuppressive therapy, nor should they have untreated brain metastases or severe allergies to monoclonal antibodies.

What is being tested?

The study tests FAZ053 alone and combined with PDR001 in patients with advanced malignancies. It aims to evaluate the safety, dosage levels, how the body processes these drugs, their effects on tumors by activating immune responses against cancer cells, and overall antitumor activity.

What are the potential side effects?

Potential side effects include reactions related to the immune system's activation such as inflammation of organs (like colitis), skin reactions (rash), endocrine issues (thyroid dysfunction), fatigue, infusion-related reactions from the drug administration process, and possibly others as this is an early-phase trial.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

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

Select...

I do not have active brain metastases needing immediate treatment.

Select...

I am currently on antibiotics for an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 41 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 41 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 41 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

Dose intensity

Dose interruptions and reductions

Incidence of Dose Limiting Toxicities (DLTs)

+1 more

Side effects data

From 2019 Phase 1 & 2 trial • 172 Patients • NCT02325739

73%

Diarrhoea

48%

Aspartate aminotransferase increased

43%

Alanine aminotransferase increased

27%

Decreased appetite

23%

Nausea

20%

Blood bilirubin increased

20%

Pyrexia

19%

Vomiting

19%

Fatigue

19%

Oedema peripheral

19%

Abdominal pain

17%

Pruritus

15%

Asthenia

14%

Constipation

13%

Anaemia

12%

Cough

12%

Abdominal pain upper

12%

Blood alkaline phosphatase increased

11%

Ascites

11%

Gamma-glutamyltransferase increased

10%

Dyspnoea

10%

Insomnia

Abdominal distension

Back pain

Weight decreased

Lipase increased

Hyperphosphataemia

Hypoalbuminaemia

Headache

Musculoskeletal pain

Hyponatraemia

Dry skin

Rash

Hypertension

Dysgeusia

Nasopharyngitis

Procedural pain

Productive cough

Platelet count decreased

Arthralgia

Blood creatine phosphokinase increased

Chills

Anxiety

Hyperlipasaemia

Myalgia

Dysphagia

Dry mouth

Rhinitis

Blood creatinine increased

Gastrooesophageal reflux disease

Hypokalaemia

Haemoptysis

Hepatic pain

Hyperglycaemia

Hyperbilirubinaemia

Pain in extremity

Upper gastrointestinal haemorrhage

Dizziness

Epistaxis

Neutrophil count decreased

Hypertriglyceridaemia

Stomatitis

Jaundice

Dyspepsia

Melaena

Hyperkalaemia

Bronchitis

Pleural effusion

Haematemesis

Peripheral swelling

Night sweats

Hepatocellular injury

Malaise

Oedema

Pain

Leukopenia

Abdominal discomfort

Duodenal ulcer

Pneumonia

Urinary tract infection

Amylase increased

C-reactive protein increased

Transaminases increased

Hypercalcaemia

Hypophosphataemia

Flank pain

Muscle spasms

Musculoskeletal chest pain

Oropharyngeal pain

Oesophageal varices haemorrhage

Dysphonia

Depression

Palpitations

Paraparesis

Bronchostenosis

Groin pain

Gastrointestinal haemorrhage

Haemorrhoids

Folliculitis

Gastritis

Lymphopenia

Oesophageal stenosis

Haemorrhoidal haemorrhage

Dyspnoea exertional

Venous thrombosis

Hypovolaemic shock

Peripheral sensory neuropathy

Cholangitis

Spinal cord compression

Varices oesophageal

Spinal pain

Biloma

Herpes zoster

Calculus urinary

Atelectasis

Thrombocytopenia

Animal bite

Hepatic function abnormal

Bone contusion

Malnutrition

Sleep disorder

Gait disturbance

Abdominal tenderness

Hypomagnesaemia

Confusional state

Bilirubin conjugated increased

Female genital tract fistula

Gastroenteritis

Blood albumin decreased

Pulmonary embolism

Gastrointestinal sounds abnormal

Duodenal obstruction

Sinusitis

Pneumonitis

Prothrombin time prolonged

Cancer pain

Rash pustular

Oesophageal ulcer

Hyperuricaemia

Tumour thrombosis

Hepatomegaly

Hepatorenal syndrome

General physical health deterioration

Hernia

Acute coronary syndrome

Coronary artery disease

Gastric varices

Cholestasis

Hepatic haematoma

Pyelonephritis acute

Varicella

Carotid artery stenosis

Cerebrovascular accident

Dysarthria

Haemorrhage intracranial

Paraesthesia

Paraplegia

Urinary retention

Aneurysm

Bleeding varicose vein

Hyperglobulinaemia

Hyperthyroidism

Angular cheilitis

Toothache

Chest discomfort

Jaundice cholestatic

Candida infection

Herpes virus infection

Tinea cruris

Activated partial thromboplastin time prolonged

Blood cholesterol increased

Blood phosphorus decreased

Haemoglobin decreased

Osteoporosis

Tumour associated fever

Visual field defect

Scrotal oedema

Varicocele

Rash macular

Rash maculo-papular

Haematoma

Hot flush

Vertigo

Hepatic cirrhosis

Multiple organ dysfunction syndrome

Lung infection

Hypoglycaemia

Liver carcinoma ruptured

Acute kidney injury

Bronchial obstruction

Vena cava thrombosis

Inferior vena caval occlusion

100%

80%

60%

40%

20%

Study treatment Arm

All Patients

Phase I: 80 mg Fed

Phase I: 50 mg Fasted

Phase I: 80 mg Fasted

Phase I: 120 mg Fasted

Phase I: 120 mg Fed

Phase I: 150 mg Fasted

Phase II: Group 1 - FGF401 120 mg QD

Phase I: FGF401 80 mg + PDR001 300 mg

Phase II: Group 2 - FGF401 120 mg QD

Phase II: Group 3 - FGF401 120 mg QD

All Patients of Single Agent FGF401

Phase I: FGF401 120 mg + PDR001 300 mg

All Patients of Combination Dose

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: FAZ053 single agentExperimental Treatment1 Intervention

Group II: FAZ053 + PDR001Experimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PDR001

2016

Completed Phase 2

~2890

0 / 3Eligibility 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

Breast cancer treatments often include targeted therapies, such as PD-L1 inhibitors like FAZ053, which block the interaction between PD-L1 and its receptors (PD-1 and B7.1), thereby activating an antitumor immune response. This is crucial for patients as it helps the immune system recognize and attack cancer cells. Other common treatments include HER2 inhibitors like trastuzumab, which target the HER2 protein on cancer cells to inhibit their growth, and hormone therapies that block hormones like estrogen, which can fuel certain types of breast cancer. Understanding these mechanisms allows patients to appreciate how these therapies specifically target cancer cells, potentially leading to more effective and personalized treatment plans.

Stress Granules in the Anti-Cancer Medications Mechanism of Action: A Systematic Scoping Review.Profile of farletuzumab and its potential in the treatment of solid tumors.[Trastuzumab (Herceptin) and breast cancer: mechanisms of resistance].