Clinical Trials /

KAZ954 Alone and With PDR001, NZV930 and NIR178 in Advanced Solid Tumors

NCT04237649

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Not yet recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

Title

  • Brief Title: KAZ954 Alone and With PDR001, NZV930 and NIR178 in Advanced Solid Tumors
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: CKAZ954A12101
  • NCT ID: NCT04237649

Conditions

  • Solid Tumors

Interventions

DrugSynonymsArms
KAZ954Arm A
PDR001Arm B
NIR178Arm C
NZV930Arm D

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Arm AExperimentalKAZ954
  • KAZ954
Arm BExperimentalKAZ954 + PDR001
  • KAZ954
  • PDR001
Arm CExperimentalKAZ954 + NIR178
  • KAZ954
  • NIR178
Arm DExperimentalKAZ954 + NZV930
  • KAZ954
  • NZV930

Eligibility 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. -

        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.

        -
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of Dose Limiting Toxicities (DLTs)
Time Frame:36 months
Safety Issue:
Description:Dose Limiting Toxicities

Secondary Outcome Measures

Measure:Overall Response Rate (ORR)
Time Frame:36 months
Safety Issue:
Description:
Measure:Disease Control Rate (DCR)
Time Frame:36 months
Safety Issue:
Description:
Measure:Progression Free Survival (PFS)
Time Frame:36 months
Safety Issue:
Description:per RECIST v1.1 and iRECIST
Measure:Serum concentration profiles of KAZ954 as a single agent Cmax
Time Frame:36 months
Safety Issue:
Description:
Measure:Serum concentration of KAZ954 in combination with PDR001 and derived PK parameters Cmax
Time Frame:36 months
Safety Issue:
Description:
Measure:Serum concentration of KAZ954 in combination with NZV930 and derived PK parameters Cmax
Time Frame:36 months
Safety Issue:
Description:
Measure:Serum/Plasma concentration of KAZ954 in combination with NIR178 Cmax
Time Frame:36 months
Safety Issue:
Description:
Measure:Presence and titer of anti-KAZ954 antibodies
Time Frame:36 months
Safety Issue:
Description:
Measure:Presence and titer of anti-PDR001 antibodies
Time Frame:36 months
Safety Issue:
Description:
Measure:Presence and titer of anti-NZV930 antibodies
Time Frame:36 months
Safety Issue:
Description:
Measure:Serum concentration profiles of KAZ954 as a single agent AUC
Time Frame:36 months
Safety Issue:
Description:
Measure:Serum concentration profiles of KAZ954 in combination with PDR001 and derived PK parameters AUC
Time Frame:36 months
Safety Issue:
Description:
Measure:Serum concentration profiles of KAZ954 incombination with NZV930 and derived PK parameters AUC
Time Frame:36 months
Safety Issue:
Description:
Measure:Serum/Plasma concentration profiles of KAZ954 in combination with NIR178 and derived PK parameters AUC
Time Frame:36 months
Safety Issue:
Description:

Details

Phase:Early Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Novartis Pharmaceuticals

Trial Keywords

  • Solid Tumors
  • KAZ954
  • PDR001
  • Spartalizumab
  • NIR178
  • NZV930
  • Immunotherapy
  • Phase I/Ib

Last Updated

January 17, 2020