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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04237649
Recruitment Status : Not yet recruiting
First Posted : January 23, 2020
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Solid Tumors Drug: KAZ954 Drug: PDR001 Drug: NIR178 Drug: NZV930 Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 145 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : February 28, 2020
Estimated Primary Completion Date : August 12, 2024
Estimated Study Completion Date : August 12, 2024

Arm Intervention/treatment
Experimental: Arm A
KAZ954
Drug: KAZ954
KAZ954 will be administered in every arm.

Experimental: Arm B
KAZ954 + PDR001
Drug: KAZ954
KAZ954 will be administered in every arm.

Drug: PDR001
KAZ954 + PDR001

Experimental: Arm C
KAZ954 + NIR178
Drug: KAZ954
KAZ954 will be administered in every arm.

Drug: NIR178
KAZ954 + NIR178

Experimental: Arm D
KAZ954 + NZV930
Drug: KAZ954
KAZ954 will be administered in every arm.

Drug: NZV930
KAZ954 + NZV930




Primary Outcome Measures :
  1. Incidence of Dose Limiting Toxicities (DLTs) [ Time Frame: 36 months ]
    Dose Limiting Toxicities


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: 36 months ]
  2. Disease Control Rate (DCR) [ Time Frame: 36 months ]
  3. Progression Free Survival (PFS) [ Time Frame: 36 months ]
    per RECIST v1.1 and iRECIST

  4. Serum concentration profiles of KAZ954 as a single agent Cmax [ Time Frame: 36 months ]
  5. Serum concentration of KAZ954 in combination with PDR001 and derived PK parameters Cmax [ Time Frame: 36 months ]
  6. Serum concentration of KAZ954 in combination with NZV930 and derived PK parameters Cmax [ Time Frame: 36 months ]
  7. Serum/Plasma concentration of KAZ954 in combination with NIR178 Cmax [ Time Frame: 36 months ]
  8. Presence and titer of anti-KAZ954 antibodies [ Time Frame: 36 months ]
  9. Presence and titer of anti-PDR001 antibodies [ Time Frame: 36 months ]
  10. Presence and titer of anti-NZV930 antibodies [ Time Frame: 36 months ]
  11. Serum concentration profiles of KAZ954 as a single agent AUC [ Time Frame: 36 months ]
  12. Serum concentration profiles of KAZ954 in combination with PDR001 and derived PK parameters AUC [ Time Frame: 36 months ]
  13. Serum concentration profiles of KAZ954 incombination with NZV930 and derived PK parameters AUC [ Time Frame: 36 months ]
  14. Serum/Plasma concentration profiles of KAZ954 in combination with NIR178 and derived PK parameters AUC [ Time Frame: 36 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04237649


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, California
UCLA
Los Angeles, California, United States, 90095
Principal Investigator: Zev Wainberg         
United States, Texas
MDACC
Houston, Texas, United States, 77030
Principal Investigator: Shubham Pant         
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04237649    
Other Study ID Numbers: CKAZ954A12101
First Posted: January 23, 2020    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Solid Tumors
KAZ954
PDR001
Spartalizumab
NIR178
NZV930
Immunotherapy
Phase I/Ib
Additional relevant MeSH terms:
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Neoplasms