Advanced Solid TumorsPhase 1NCT02936102
A Study of FAZ053 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.
A Phase 1 study testing FAZ053 and PDR001 in people with Advanced Solid Tumors and Triple Negative Breast Cancer, run by Novartis Pharmaceuticals at 12 sites in 9 countries.
Trial summary
The purpose of this "first-in-human" study of FAZ053 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of FAZ053 administered Intravenously (i.v.)as a single agent or in combination with PDR001 in adult patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Advanced Solid Tumors, Triple Negative Breast Cancer, Chordoma and Alveolar Soft Part Sarcoma
- What is being tested?
- FAZ053 and PDR001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 12 sitesin 9 countries
- Study dates
- 20 Oct 2016to 22 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent prior to any procedure.
- Dose escalation cohorts of FAZ053 single agent and FAZ053 in combination with PDR001: Patients with advanced/metastatic solid tumors with measurable or non-measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 who may or may not have received prior treatment with an immune checkpoint inhibitor, who have progressed despite standard therapy, or for whom no standard therapy is available.
- Dose expansion groups of FAZ053 single agent: Patients with advanced/metastatic solid tumors with at least one measurable lesion as determined by RECIST version 1.1 who may or may not have received prior treatment with an immune checkpoint inhibitor (for FAZ053 single agent no treatment with an anti-PD-L1 inhibitor is permitted), who have progressed despite standard therapy, or for whom no standard therapy is available and fit into one of the following groups:
- FAZ053 single agent: TNBC/ Chordoma/ ASPS
- Performance Status (PS) ≤ 2:
- Patient must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines. Patient must be willing to undergo a new tumor biopsy at screening/ baseline and during therapy on this study.
Who cannot join
- 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.
- History of severe hypersensitivity to study treatment excipients and additives or other monoclonal antibodies (mAbs) and/or their excipients.
- Active, known or suspected autoimmune disease. Patients with vitiligo, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur in the absence of an external trigger should not be excluded. Patients previously exposed to anti-PD-1/PD-L1 treatment who are adequately treated for skin rash or with replacement therapy for endocrinopathies should not be excluded.
- Treatment with cytotoxic or targeted antineoplastics within 3 weeks of initiation of study treatment. For cytotoxic agents that have major delayed toxicity a washout period of one cycle is indicated (examples are nitrosoureas and mitomycin C which typically require a 6 week washout). Prior antibodies or immunotherapies require a 6 week washout.
- Patients receiving systemic chronic steroid therapy or any immunosuppressive therapy (≥ 10mg/day prednisone or equivalent). Topical, inhaled, nasal and ophthalmic steroids are allowed.
- Active infection requiring systemic antibiotic therapy.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
12 sites in 9 countries.
12 sites in 9 countries
United States2 sites
UT MD Anderson Cancer Center
Houston, Texas, 77030
Memorial Sloan Kettering Cancer Ctr
New York, New York, 10065
Italy2 sites
Novartis Investigative Site
Milan, MI, 20133
Novartis Investigative Site
Modena, MO, 41124
Spain2 sites
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Seville, Andalusia, 41013
About this study
Official title: A Phase I, Open-label, Multi-center Dose Escalation Study of FAZ053 as Single Agent and in Combination With PDR001 in Adult Patients With Advanced Malignancies
The purpose of this "first-in-human" study of FAZ053 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of FAZ053 administered Intravenously (i.v.)as a single agent or in combination with PDR001 in adult patients with advanced solid tumors.
By blocking the interaction between Programmed Death Ligand-1 (PD-L1) and its receptors, Programmed Death-1 (PD-1) and B7.1, FAZ053 inhibits the PD-L1 immune checkpoint, resulting in activation of an antitumor immune response by activating effector T-cells and inhibiting regulatory T-cells.
Read more
This study has been designed as a Phase I, open-label, multi-center study with a dose escalation part of FAZ053 as single agent and in combination with PDR001, followed by a dose expansion part of FAZ053 as single agent.
FAZ053 will initially be dosed every three weeks. A less frequent dosing regimen such as every 6 weeks may be evaluated in parallel.
A patient may continue treatment with FAZ053 single agent or in combination with PDR001 until the patient experiences unacceptable toxicity, confirmed disease progression per immune related Response Criteria and/or treatment is discontinued at the discretion of the investigator or the patient.
- Conditions
- Advanced Solid Tumors, Triple Negative Breast Cancer, Chordoma and Alveolar Soft Part Sarcoma
- Being tested
- FAZ053, PDR001
- Keywords
- Phase I, FAZ053, PDR001, Checkpoint inhibitor, PD-L1, PD-1
- Medical subject headings
- Triple Negative Breast Neoplasms, Chordoma, Sarcoma, Alveolar Soft Part
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAZ053Drug
Anti-PD-L1 Antibody
PDR001Drug
Anti-PD-1 Antibody
| Study group | Role | What they receive |
|---|---|---|
| FAZ053 single agent | Experimental | Not described Receives: Drug: FAZ053 |
| FAZ053 + PDR001 | Experimental | Not described Receives: Drug: FAZ053; Drug: PDR001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Incidence and severity of AEs and SAEs by treatment group, including changes in vital signs, electrocardiograms (ECGs) and laboratory parameters qualifying and reported as AEs.
Measured: throughout the study and up to 150 days after end of treatment (up to approximately 46 months)
Incidence of Dose Limiting Toxicities (DLTs)
A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications, which occurs within the first 21 days of treatment with FAZ053 alone or within the first 42 days when FAZ053 is given in combination with PDR001 during the dose escalation part of the study. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Measured: 21 days (single agent FAZ053) and 42 days (FAZ053+PDR001)
Dose interruptions and reductions
Number of participants with dose interruptions and reductions as a measure of tolerability.
Measured: Up to approximately 41 months
Dose intensity
Dose intensity is defined as actual dose received divided by actual duration of exposure.
Measured: Up to approximately 41 months
Secondary outcomes (22)
Serum concentration-time profiles of FAZ053 as single agent and FAZ053 in combination with PDR001.
Measured: 41 months
Presence of anti-FAZ053 and anti-PDR001.
Measured: 41 months
Concentration of anti-FAZ053 and anti-PDR001.
Measured: 41 months
Receptor Occupancy (RO) profiles when FAZ053 is given as single agent.
Measured: 41 months
Total soluble/shed PD-L1 concentration-time profiles when FAZ053 is given as single agent and for FAZ053 in combination with PDR001.
Measured: 41 months
Histopathology of tumor infiltrating lymphocytes (TILs) by hematoxylin.
Measured: 41 months
Histopathology of tumor infiltrating lymphocytes (TILs) by eosin (H&E) stain.
Measured: 41 months
Overall response rate (ORR) per RECIST v1.1
Measured: 41 months
Best overall response per RECIST v1.1
Measured: 41 months
Disease control rate per RECIST 1.1
Measured: 41 months
Progression free survival (PFS) per RECIST 1.1
Measured: 41 months
Duration of response per RECIST 1.1
Measured: 41 months
Overall response rate (ORR) per immune related Response Criteria (irRC).
Measured: 41 months
Progression free survival (PFS) per immune related Response Criteria (irRC).
Measured: 41 months
Characterization of Tumor Infiltrating Lymphocytes (TILs) by Immunohistochemistry (IHC)
Measured: 41 months
Characterization of myeloid cell infiltrate by IHC.
Measured: 41 months
Area under the curve (AUC) for FAZ053 as single agent and FAZ053 in combination with PDR001.
Measured: 41 months
Cmax for FAZ053 as single agent and FAZ053 in combination with PDR001.
Measured: 41 months
Tmax for FAZ053 as single agent and FAZ053 in combination with PDR001.
Measured: 41 months
Half-life for FAZ053 as single agent and FAZ053 in combination with PDR001.
Measured: 41 months
Clast for FAZ053 as single agent and FAZ053 in combination with PDR001.
Measured: 41 months
Tlast for FAZ053 as single agent and FAZ053 in combination with PDR001.
Measured: 41 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study start20 Oct 2016
- Primary completion22 Nov 2024
- Study completion22 Nov 2024
Why it stopped: The early termination was based on a business decision that FAZ053 would no longer be formulated and was not a consequence of any safety concern.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936102
- Sponsor's protocol ID
- CFAZ053X2101
- Other IDs
- 2016-001470-15, 2016
- Status last verified
- Nov 2025
- First submitted
- 15 Sep 2016
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Multi-center Dose Escalation Study of FAZ053 as Single Agent and in Combination With PDR001 in Adult Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT02936102
- Acronym / sponsor ID
- CFAZ053X2101
- Conditions
- Advanced Solid Tumors, Triple Negative Breast Cancer, Chordoma and Alveolar Soft Part Sarcoma
- Keywords
- Phase I, FAZ053, PDR001, Checkpoint inhibitor, PD-L1, PD-1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The early termination was based on a business decision that FAZ053 would no longer be formulated and was not a consequence of any safety concern.
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2016 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 22 Nov 2024 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this "first-in-human" study of FAZ053 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of FAZ053 administered Intravenously (i.v.)as a single agent or in combination with PDR001 in adult patients with advanced solid tumors.
By blocking the interaction between Programmed Death Ligand-1 (PD-L1) and its receptors, Programmed Death-1 (PD-1) and B7.1, FAZ053 inhibits the PD-L1 immune checkpoint, resulting in activation of an antitumor immune response by activating effector T-cells and inhibiting regulatory T-cells.
This study has been designed as a Phase I, open-label, multi-center study with a dose escalation part of FAZ053 as single agent and in combination with PDR001, followed by a dose expansion part of FAZ053 as single agent.
FAZ053 will initially be dosed every three weeks. A less frequent dosing regimen such as every 6 weeks may be evaluated in parallel.
A patient may continue treatment with FAZ053 single agent or in combination with PDR001 until the patient experiences unacceptable toxicity, confirmed disease progression per immune related Response Criteria and/or treatment is discontinued at the discretion of the investigator or the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FAZ053 single agent | Experimental | Drug: FAZ053 |
| FAZ053 + PDR001 | Experimental | Drug: FAZ053, Drug: PDR001 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent prior to any procedure.
- Dose escalation cohorts of FAZ053 single agent and FAZ053 in combination with PDR001: Patients with advanced/metastatic solid tumors with measurable or non-measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 who may or may not have received prior treatment with an immune checkpoint inhibitor, who have progressed despite standard therapy, or for whom no standard therapy is available.
- Dose expansion groups of FAZ053 single agent: Patients with advanced/metastatic solid tumors with at least one measurable lesion as determined by RECIST version 1.1 who may or may not have received prior treatment with an immune checkpoint inhibitor (for FAZ053 single agent no treatment with an anti-PD-L1 inhibitor is permitted), who have progressed despite standard therapy, or for whom no standard therapy is available and fit into one of the following groups:
- FAZ053 single agent: TNBC/ Chordoma/ ASPS
- Performance Status (PS) ≤ 2:
Key exclusion criteria (7 listed)
- 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.
- History of severe hypersensitivity to study treatment excipients and additives or other monoclonal antibodies (mAbs) and/or their excipients.
- Active, known or suspected autoimmune disease. Patients with vitiligo, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur in the absence of an external trigger should not be excluded. Patients previously exposed to anti-PD-1/PD-L1 treatment who are adequately treated for skin rash or with replacement therapy for endocrinopathies should not be excluded.
- Treatment with cytotoxic or targeted antineoplastics within 3 weeks of initiation of study treatment. For cytotoxic agents that have major delayed toxicity a washout period of one cycle is indicated (examples are nitrosoureas and mitomycin C which typically require a 6 week washout). Prior antibodies or immunotherapies require a 6 week washout.
- Patients receiving systemic chronic steroid therapy or any immunosuppressive therapy (≥ 10mg/day prednisone or equivalent). Topical, inhaled, nasal and ophthalmic steroids are allowed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAZ053Anti-PD-L1 Antibody | Drug | FAZ053 + PDR001, FAZ053 single agent |
| PDR001Anti-PD-1 Antibody | Drug | FAZ053 + PDR001 |
Primary outcome
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: throughout the study and up to 150 days after end of treatment (up to approximately 46 months)
Incidence and severity of AEs and SAEs by treatment group, including changes in vital signs, electrocardiograms (ECGs) and laboratory parameters qualifying and reported as AEs.
Incidence of Dose Limiting Toxicities (DLTs)
Time frame: 21 days (single agent FAZ053) and 42 days (FAZ053+PDR001)
A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications, which occurs within the first 21 days of treatment with FAZ053 alone or within the first 42 days when FAZ053 is given in combination with PDR001 during the dose escalation part of the study. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Dose interruptions and reductions
Time frame: Up to approximately 41 months
Number of participants with dose interruptions and reductions as a measure of tolerability.
Dose intensity
Time frame: Up to approximately 41 months
Dose intensity is defined as actual dose received divided by actual duration of exposure.
22 secondary outcomes
Serum concentration-time profiles of FAZ053 as single agent and FAZ053 in combination with PDR001.
Time frame: 41 months
Presence of anti-FAZ053 and anti-PDR001.
Time frame: 41 months
Concentration of anti-FAZ053 and anti-PDR001.
Time frame: 41 months
Receptor Occupancy (RO) profiles when FAZ053 is given as single agent.
Time frame: 41 months
Total soluble/shed PD-L1 concentration-time profiles when FAZ053 is given as single agent and for FAZ053 in combination with PDR001.
Time frame: 41 months
Histopathology of tumor infiltrating lymphocytes (TILs) by hematoxylin.
Time frame: 41 months
Histopathology of tumor infiltrating lymphocytes (TILs) by eosin (H&E) stain.
Time frame: 41 months
Overall response rate (ORR) per RECIST v1.1
Time frame: 41 months
Best overall response per RECIST v1.1
Time frame: 41 months
Disease control rate per RECIST 1.1
Time frame: 41 months
Progression free survival (PFS) per RECIST 1.1
Time frame: 41 months
Duration of response per RECIST 1.1
Time frame: 41 months
Overall response rate (ORR) per immune related Response Criteria (irRC).
Time frame: 41 months
Progression free survival (PFS) per immune related Response Criteria (irRC).
Time frame: 41 months
Characterization of Tumor Infiltrating Lymphocytes (TILs) by Immunohistochemistry (IHC)
Time frame: 41 months
Characterization of myeloid cell infiltrate by IHC.
Time frame: 41 months
Area under the curve (AUC) for FAZ053 as single agent and FAZ053 in combination with PDR001.
Time frame: 41 months
Cmax for FAZ053 as single agent and FAZ053 in combination with PDR001.
Time frame: 41 months
Tmax for FAZ053 as single agent and FAZ053 in combination with PDR001.
Time frame: 41 months
Half-life for FAZ053 as single agent and FAZ053 in combination with PDR001.
Time frame: 41 months
Clast for FAZ053 as single agent and FAZ053 in combination with PDR001.
Time frame: 41 months
Tlast for FAZ053 as single agent and FAZ053 in combination with PDR001.
Time frame: 41 months
Results and safety
The study was stopped early (reason given: The early termination was based on a business decision that FAZ053 would no longer be formulated and was not a consequence of any safety concern.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- CFAZ053X2101 Clinical Trial ResultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
12 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FAZ053 and PDR001 in people with Advanced Solid Tumors and Triple Negative Breast Cancer, run by Novartis Pharmaceuticals at 12 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Italy, Spain, Canada, France and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The early termination was based on a business decision that FAZ053 would no longer be formulated and was not a consequence of any safety concern.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: throughout the study and up to 150 days after end of treatment (up to approximately 46 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.