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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 41 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug, FAZ053, to see if it is safe and effective when given alone or with another drug, PDR001. The trial will test different doses of FAZ053 to see what the maximum tolerated dose is.

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.Check my eligibility
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.See study design
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
Select...
I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~41 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 41 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose intensity
Dose interruptions and reductions
Incidence of Dose Limiting Toxicities (DLTs)
+1 more
Secondary outcome measures
Area under the curve (AUC) for FAZ053 as single agent and FAZ053 in combination with PDR001.
Best overall response per RECIST v1.1
Characterization of Tumor Infiltrating Lymphocytes (TILs) by Immunohistochemistry (IHC)
+19 more

Side effects data

From 2019 Phase 1 & 2 trial • 172 Patients • NCT02325739
83%
Aspartate aminotransferase increased
67%
Alanine aminotransferase increased
67%
Diarrhoea
50%
Pyrexia
50%
Abdominal distension
50%
Hyperphosphataemia
33%
Blood bilirubin increased
33%
Oedema peripheral
33%
Anaemia
33%
Abdominal pain
33%
Nausea
33%
Fatigue
33%
Neutrophil count decreased
33%
Pruritus
33%
Rash
17%
Epistaxis
17%
Productive cough
17%
Liver carcinoma ruptured
17%
Tinea cruris
17%
Dysgeusia
17%
Oesophageal varices haemorrhage
17%
Hyperglycaemia
17%
Blood creatinine increased
17%
Hypokalaemia
17%
Vomiting
17%
Rash pustular
17%
Sinusitis
17%
Blood creatine phosphokinase increased
17%
Weight decreased
17%
Gamma-glutamyltransferase increased
17%
Platelet count decreased
17%
Arthralgia
17%
Myalgia
17%
Insomnia
17%
Dyspnoea exertional
17%
Hot flush
17%
Headache
17%
Cough
17%
Pneumonitis
17%
Hyperthyroidism
17%
Blood alkaline phosphatase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase I: FGF401 120 mg + PDR001 300 mg
All Patients of Combination Dose
Phase I: 120 mg Fed
Phase I: 150 mg Fasted
Phase II: Group 1 - FGF401 120 mg QD
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 80 mg + PDR001 300 mg
All Patients
Phase I: 50 mg Fasted
Phase I: 80 mg Fasted
Phase I: 80 mg Fed
Phase I: 120 mg Fasted

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
~2700

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,199 Total Patients Enrolled
88 Trials studying Breast Cancer
37,812 Patients Enrolled for Breast Cancer

Media Library

FAZ053 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02936102 — Phase 1
Breast Cancer Research Study Groups: FAZ053 single agent, FAZ053 + PDR001
Breast Cancer Clinical Trial 2023: FAZ053 Highlights & Side Effects. Trial Name: NCT02936102 — Phase 1
FAZ053 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02936102 — Phase 1
Breast Cancer Patient Testimony for trial: Trial Name: NCT02936102 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this particular clinical trial a pioneering endeavor?

"Since 2011, FAZ053 has been under intense clinical scrutiny. The initial trial was sponsored by Novartis Pharmaceuticals in the same year and included 185 participants. This study set off a chain of events culminating in Phase 1 drug approval for FAZ053 at present day, with 27 active studies spanning 122 cities and 35 nations."

Answered by AI

What has been observed concerning the security of FAZ053 for human consumption?

"Due to the fact that FAZ053 is entering Phase 1 trials, there remains a limited amount of data pertaining to its safety and efficacy. Consequently, it was given an overall rating of one on our scale from 1-3."

Answered by AI

How many individuals are actively participating in this clinical experiment?

"At present, this medical trial is closed to recruitment. The first posting was on October 20th of 2016 and the last update occurred on July 28th 2022. If one desires to investigate other studies, 849 clinical trials are actively searching for individuals with solid tumors or advanced solid tumors while 27 trials specifically seek patients taking part in FAZ053."

Answered by AI

Could you provide me with a summary of all the scientific investigations done using FAZ053?

"At present, 27 trials for FAZ053 are underway. 1 of those is in the advanced Phase 3 stage and 508 sites across the United States offer enrolment opportunities. The majority of these studies take place in New york City."

Answered by AI

Is there still room for enrolment in this investigation?

"Per data hosted on clinicaltrials.gov, this research initiative is not currently enrolling participants. Initially posted in October of 2016 and last updated July 28th 2022, the trial has ceased to recruit candidates at this time; however, 876 alternative studies are presently open for patient recruitment."

Answered by AI

Who else is applying?

What site did they apply to?
UT MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

What questions have other patients asked about this trial?

Do I have to pay for the treatment? How long will my treatment process take?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I hope thus clinical trial help me.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of FAZ053 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.
2016. "A Study of FAZ053 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02936102.
All > Metastatic Triple Negative Breast Cancer > Chordoma
~10 spots leftby Nov 2024
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