Clinical Trials List
Protocol NumberCKAZ954A12101
NCT Number(ClinicalTrials.gov Identfier)NCT04237649
Completed
2020-03-02 - 2023-09-15
Phase I
Not yet recruiting1
A Phase I/Ib, Open-label, Multi-center, Study of KAZ954 as a Single Agent and in Combination With Spartalizumab, NZV930 and NIR178 in Patients With Advanced Solid Tumors
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
Novartis Pharmaceuticals
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Ann-Lii Cheng 無
- 梁逸歆 無
- 陳國興 無
- JHE-CYUAN GUO 無
- SHIH-HUNG YANG 無
- Chiun Hsu 無
- TA-CHEN HUANG 無
- SHIH-HUNG YANG 未分科
- Chih-Hung Hsu 無
- 郭弘揚 無
- Kun-Huei Yeh 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Advanced Solid Tumors
Objectives
The purpose of this trial is to explore the clinical utility of several therapies in patients with advanced cancer.
This is a multi-center, open-label Phase I/Ib study. The study consists of a dose escalation part, a dose expansion part testing KAZ954 as a single agent or KAZ954 in combination with PDR001, NZV930 and NIR178. The dose escalation parts will estimate the MTD and/or RD and test different dosing schedules.
The dose expansion parts of the study will use the MTD/RDE determined in the dose escalation part to assess the activity, safety and tolerability of the investigational products in patients with specific types of cancer.
Approximately 135 adult patients with advanced solid tumors will be enrolled.
Test Drug
KAZ954, Spartalizumab, NZV930 & NIR178
Active Ingredient
KAZ954
NIR178
NZV930
PDR001
NIR178
NZV930
PDR001
Dosage Form
Concentrate for solution for infusion
100 mg
Powder for solution for infusion
Hard capsules
100 mg
Powder for solution for infusion
Hard capsules
Dosage
150 mg
mg/ 4 mL vial
100 mg
40 mg/ 80 mg/ 160 mg
mg/ 4 mL vial
100 mg
40 mg/ 80 mg/ 160 mg
Endpoints
Primary Outcome Measures :
Incidence of Dose Limiting Toxicities (DLTs) [ Time Frame: 36 months ]
Dose Limiting Toxicities
Secondary Outcome Measures :
Overall Response Rate (ORR) [ Time Frame: 36 months ]
Disease Control Rate (DCR) [ Time Frame: 36 months ]
Progression Free Survival (PFS) [ Time Frame: 36 months ]
per RECIST v1.1 and iRECIST
Serum concentration profiles of KAZ954 as a single agent Cmax [ Time Frame: 36 months ]
Serum concentration of KAZ954 in combination with PDR001 and derived PK parameters Cmax [ Time Frame: 36 months ]
Serum concentration of KAZ954 in combination with NZV930 and derived PK parameters Cmax [ Time Frame: 36 months ]
Serum/Plasma concentration of KAZ954 in combination with NIR178 Cmax [ Time Frame: 36 months ]
Presence and titer of anti-KAZ954 antibodies [ Time Frame: 36 months ]
Presence and titer of anti-PDR001 antibodies [ Time Frame: 36 months ]
Presence and titer of anti-NZV930 antibodies [ Time Frame: 36 months ]
Serum concentration profiles of KAZ954 as a single agent AUC [ Time Frame: 36 months ]
Serum concentration profiles of KAZ954 in combination with PDR001 and derived PK parameters AUC [ Time Frame: 36 months ]
Serum concentration profiles of KAZ954 incombination with NZV930 and derived PK parameters AUC [ Time Frame: 36 months ]
Serum/Plasma concentration profiles of KAZ954 in combination with NIR178 and derived PK parameters AUC [ Time Frame: 36 months ]
Assess the correlation between PD-L1 expression level in tumor using a validated assay and response to KAZ954 and in combo with PDR001, NIR178 or NZV930 [ Time Frame: 36 months ]
Expression of PD-L1, and determination of ORR & PFS per RECIST 1.1 and iRECIST.
Incidence of Dose Limiting Toxicities (DLTs) [ Time Frame: 36 months ]
Dose Limiting Toxicities
Secondary Outcome Measures :
Overall Response Rate (ORR) [ Time Frame: 36 months ]
Disease Control Rate (DCR) [ Time Frame: 36 months ]
Progression Free Survival (PFS) [ Time Frame: 36 months ]
per RECIST v1.1 and iRECIST
Serum concentration profiles of KAZ954 as a single agent Cmax [ Time Frame: 36 months ]
Serum concentration of KAZ954 in combination with PDR001 and derived PK parameters Cmax [ Time Frame: 36 months ]
Serum concentration of KAZ954 in combination with NZV930 and derived PK parameters Cmax [ Time Frame: 36 months ]
Serum/Plasma concentration of KAZ954 in combination with NIR178 Cmax [ Time Frame: 36 months ]
Presence and titer of anti-KAZ954 antibodies [ Time Frame: 36 months ]
Presence and titer of anti-PDR001 antibodies [ Time Frame: 36 months ]
Presence and titer of anti-NZV930 antibodies [ Time Frame: 36 months ]
Serum concentration profiles of KAZ954 as a single agent AUC [ Time Frame: 36 months ]
Serum concentration profiles of KAZ954 in combination with PDR001 and derived PK parameters AUC [ Time Frame: 36 months ]
Serum concentration profiles of KAZ954 incombination with NZV930 and derived PK parameters AUC [ Time Frame: 36 months ]
Serum/Plasma concentration profiles of KAZ954 in combination with NIR178 and derived PK parameters AUC [ Time Frame: 36 months ]
Assess the correlation between PD-L1 expression level in tumor using a validated assay and response to KAZ954 and in combo with PDR001, NIR178 or NZV930 [ Time Frame: 36 months ]
Expression of PD-L1, and determination of ORR & PFS per RECIST 1.1 and iRECIST.
Inclution Criteria
Inclusion Criteria:
Patients with metastatic and/or advanced malignancies not amenable to curative treatment by surgery.
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 and during the study.
ECOG Performance Status of <2. -
Patients with metastatic and/or advanced malignancies not amenable to curative treatment by surgery.
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 and during the study.
ECOG Performance Status of <2. -
Exclusion Criteria
Exclusion Criteria:
Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require concurrent treatment - including surgery, radiation and/or corticosteroids.
History of severe hypersensitivity reaction to any ingredient of study drug(s) and other mAbs and/or their excipients.
Impaired cardiac function HIV Known history of tuberculosis Systemic chronic steroid therapy
Other protocol-defined inclusion/exclusion criteria may apply.
Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require concurrent treatment - including surgery, radiation and/or corticosteroids.
History of severe hypersensitivity reaction to any ingredient of study drug(s) and other mAbs and/or their excipients.
Impaired cardiac function HIV Known history of tuberculosis Systemic chronic steroid therapy
Other protocol-defined inclusion/exclusion criteria may apply.
The Estimated Number of Participants
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Taiwan
25 participants
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Global
210 participants
