Clinical Trials List
Protocol NumberCFAZ053X2101
NCT Number(ClinicalTrials.gov Identfier)NCT02936102
Completed
2016-10-20 - 2024-11-22
Phase I
Terminated1
ICD-10C80.1
Malignant (primary) neoplasm, unspecified
ICD-9190.0
Malignant neoplasm of eyeball, except conjunctiva, cornea, retina and choroid
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
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
-
Sponsor
Novartis Pharmaceuticals
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Trial scale
Multi-Regional Multi-Center
-
Update
2026/03/01
Investigators and Locations
Co-Principal Investigator
- 廖斌志 無
- CHAO-CHI HO CHAO-CHI HO 無
- YEN-SHEN LU 無
- Wen-Fang Cheng 無
- James Chih-Hsin Yang 無
- Chong-Jen Yu 無
- 廖唯昱 無
- 林季宏 無
- Jih-Hsiang Lee 無
- JIN-YUAN SHIH 無
- 許嘉林 無
- 張端瑩 無
- 徐偉勛 無
- 陳冠宇 無
- 蔡子修 無
- Wei-Wu Chen 無
The Actual Total Number of Participants Enrolled
0 Completed
Audit
None
Condition/Disease
Advanced Solid Tumors
Objectives
Primary Objective(s) and Key Secondary Objective
To assess safety and tolerability of FAZ053 single agent and in combination with
PDR001 and to identify recommended doses and schedules for future studies.
Secondary Objectives
● To characterize the pharmacokinetic profiles of FAZ053 as single agent and in combination with PDR001
● To assess emergence of anti-FAZ053 and anti-PDR001 antibodies following one or more i.v. infusions of FAZ053 single agent and in combination with PDR001
● To characterize the pharmacodynamics profiles of FAZ053 as single agent and in combination with PDR001
● To characterize changes in the immune infiltrate in tumors following the administration of FAZ053 single agent and in combination with PDR001
● To assess the preliminary anti-tumor activity of FAZ053 as a single agent and in combination with PDR001
Test Drug
FAZ053 & PDR001
Active Ingredient
FAZ053
PDR001
PDR001
Dosage Form
Lyophilisate in vial for i.v. infusion
powder for solution for infusion
powder for solution for infusion
Dosage
100 mg FAZ053 per vial
100 mg PDR001 per vial
100 mg PDR001 per vial
Endpoints
Efficacy assessments
Tumor assessment per RECIST v1.1 and per irRC
Safety assessments
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events
(SAEs), including changes in laboratory values, vital signs and Electrocardiograms
(ECGs).
Other assessments
Immunogenicity assessment on PK samples.
Pharmacodynamics assessments on pre- and post- treatment newly obtained tumor
samples, in blood plasma and in peripheral blood mononuclear cells (PBMCs).
Tumor assessment per RECIST v1.1 and per irRC
Safety assessments
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events
(SAEs), including changes in laboratory values, vital signs and Electrocardiograms
(ECGs).
Other assessments
Immunogenicity assessment on PK samples.
Pharmacodynamics assessments on pre- and post- treatment newly obtained tumor
samples, in blood plasma and in peripheral blood mononuclear cells (PBMCs).
Inclution Criteria
1. Written informed consent must be obtained prior to any procedure.
2. Age ≥ 18 years
3. 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.
4. Dose expansion groups of FAZ053 single agent and FAZ053 in
combination with PDR001: 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:
● NSCLC
● Patients with NSCLC must have had disease recurrence or
progression during or after no more than one prior systemic chemotherapy
regimen (platinum doublet-based) for advanced or metastatic disease.
Prior maintenance therapy is allowed (e.g. pemetrexed, erlotinib,
bevacizumab).
● Only patients with EGFR mutation-negative tumor are eligible
(defined as negative for exon 19 deletions and for the L858R mutation in
EGFR at a minimum; however, if more extensive EGFR mutation testing
has been performed, the tumor must not harbor any known activating
EGFR mutations in Exons 18-21 in order to be considered EGFR mutationnegative). All patients must be tested for EGFR mutational status and, for
ALK translocation status if no mutation is detected in EGFR. Patients with
ALK translocation-positive NSCLC must have had disease progression
following treatment with a corresponding inhibitor and no more than one
systemic chemotherapy regimen (platinum doublet-based), in any
sequence.
● TNBC negative for estrogen receptor (ER), progesterone receptor (PR)
and human epidermal growth factor receptor 2 (HER2)
● Endometrial cancer (this group will also include patients with microsatellite
instability (MSI)-high status)
● Anaplastic thyroid cancer without evidence of airway compression clinically
or on imaging
● Selected indication(s) in dose expansion group Q6W dosing regimen
FAZ053 in combination with PDR001:
● NSCLC:
● Patients with NSCLC must have had disease recurrence or
progression during or after no more than one prior systemic chemotherapy
regimen (platinum doublet-based) for advanced or metastatic disease.
Prior maintenance therapy is allowed (e.g. pemetrexed, erlotinib,
bevacizumab).
● Only patients with EGFR mutation-negative tumor are eligible
(defined as negative for exon 19 deletions and for the L858R mutation in
EGFR at a minimum; however, if more extensive EGFR mutation testing
has been performed, the tumor must not harbor any known activating
EGFR mutations in Exons 18-21 in order to be considered EGFR mutationnegative). All patients must be tested for EGFR mutational status and, for
ALK translocation status if no mutation is detected in EGFR. Patients with
ALK translocation-positive NSCLC must have had disease progression
following treatment with a corresponding inhibitor and no more than one
systemic chemotherapy regimen (platinum doublet-based), in any
sequence.
● TNBC negative for ER, PR and HER2
● Selected indication(s) in dose expansion group Q6W dosing regimen
5. ECOG Performance Status ≤ 2
6. 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 or at molecular pre-screening if
applicable, and during therapy on this study. Exceptions may be made on a case by
case basis after documented discussion with Novartis.
2. Age ≥ 18 years
3. 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.
4. Dose expansion groups of FAZ053 single agent and FAZ053 in
combination with PDR001: 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:
● NSCLC
● Patients with NSCLC must have had disease recurrence or
progression during or after no more than one prior systemic chemotherapy
regimen (platinum doublet-based) for advanced or metastatic disease.
Prior maintenance therapy is allowed (e.g. pemetrexed, erlotinib,
bevacizumab).
● Only patients with EGFR mutation-negative tumor are eligible
(defined as negative for exon 19 deletions and for the L858R mutation in
EGFR at a minimum; however, if more extensive EGFR mutation testing
has been performed, the tumor must not harbor any known activating
EGFR mutations in Exons 18-21 in order to be considered EGFR mutationnegative). All patients must be tested for EGFR mutational status and, for
ALK translocation status if no mutation is detected in EGFR. Patients with
ALK translocation-positive NSCLC must have had disease progression
following treatment with a corresponding inhibitor and no more than one
systemic chemotherapy regimen (platinum doublet-based), in any
sequence.
● TNBC negative for estrogen receptor (ER), progesterone receptor (PR)
and human epidermal growth factor receptor 2 (HER2)
● Endometrial cancer (this group will also include patients with microsatellite
instability (MSI)-high status)
● Anaplastic thyroid cancer without evidence of airway compression clinically
or on imaging
● Selected indication(s) in dose expansion group Q6W dosing regimen
FAZ053 in combination with PDR001:
● NSCLC:
● Patients with NSCLC must have had disease recurrence or
progression during or after no more than one prior systemic chemotherapy
regimen (platinum doublet-based) for advanced or metastatic disease.
Prior maintenance therapy is allowed (e.g. pemetrexed, erlotinib,
bevacizumab).
● Only patients with EGFR mutation-negative tumor are eligible
(defined as negative for exon 19 deletions and for the L858R mutation in
EGFR at a minimum; however, if more extensive EGFR mutation testing
has been performed, the tumor must not harbor any known activating
EGFR mutations in Exons 18-21 in order to be considered EGFR mutationnegative). All patients must be tested for EGFR mutational status and, for
ALK translocation status if no mutation is detected in EGFR. Patients with
ALK translocation-positive NSCLC must have had disease progression
following treatment with a corresponding inhibitor and no more than one
systemic chemotherapy regimen (platinum doublet-based), in any
sequence.
● TNBC negative for ER, PR and HER2
● Selected indication(s) in dose expansion group Q6W dosing regimen
5. ECOG Performance Status ≤ 2
6. 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 or at molecular pre-screening if
applicable, and during therapy on this study. Exceptions may be made on a case by
case basis after documented discussion with Novartis.
Exclusion Criteria
1. 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.
2. History of severe hypersensitivity to study treatment excipients and additives or
other mAbs and/or their excipients.
3. 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.
4. 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.
5. Patients receiving systemic chronic steroid therapy or any immunosuppressive
therapy (≥ 10mg/day prednisone or equivalent). Topical, inhaled, nasal and
ophthalmic steroids are allowed.
6. Active infection requiring systemic antibiotic therapy.
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.
2. History of severe hypersensitivity to study treatment excipients and additives or
other mAbs and/or their excipients.
3. 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.
4. 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.
5. Patients receiving systemic chronic steroid therapy or any immunosuppressive
therapy (≥ 10mg/day prednisone or equivalent). Topical, inhaled, nasal and
ophthalmic steroids are allowed.
6. Active infection requiring systemic antibiotic therapy.
The Estimated Number of Participants
-
Taiwan
16 participants
-
Global
154 participants
