NCT04237649

Brief Summary

The primary objective of the trial was to characterize the safety, tolerability, and maximum tolerated dose (MTD)/recommended dose (RD) for expansion of single agent KAZ954 and KAZ954 in combination with PDR001, NIR178 and NZV930.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Feb 2020

Typical duration for early_phase_1

Geographic Reach
8 countries

13 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
28 days until next milestone

Study Start

First participant enrolled

February 20, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

May 18, 2025

Status Verified

May 1, 2025

Enrollment Period

3.6 years

First QC Date

January 17, 2020

Last Update Submit

May 14, 2025

Conditions

Solid Tumors

Keywords

Solid TumorsKAZ954PDR001SpartalizumabNIR178NZV930ImmunotherapyPhase I/Ib

Outcome Measures

Primary Outcomes (4)

  • Incidence of Dose Limiting Toxicities (DLTs)

    A dose-limiting toxicity (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 DLT period. The DLT period for Schedule 1 is 28 days and covers two infusions. The DLT period for Schedule 2 and Schedule 3 is 35 days to cover two infusions of the Experimental dose. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.

    Up to 35 days

  • Incidence of adverse events and serious adverse events during the on-treatment period

    Number of participants with AEs (any AE regardless of seriousness) and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. The on-treatment period is defined from the day of first administration of study treatment up to 30 days after the date of its last administration.

    Up to approximately 52 weeks (KAZ954 single agent), 20 weeks (KAZ954+PDR001) and 24 weeks (KAZ954+NIR178)

  • Number of participants with dose interruptions and dose reductions

    Number of participants with at least one dose interruption or reduction of KAZ954 and its combination partners during study treatment to assess tolerability.

    Up to approximately 48 weeks (KAZ954 single agent), 16 weeks (KAZ954+PDR001) and 20 weeks (KAZ954+NIR178)

  • Dose intensity of study treatment

    Dose intensity of KAZ954 and its combination partners computed as the ratio of actual cumulative dose received and actual duration of exposure.

    Up to approximately 48 weeks (KAZ954 single agent), 16 weeks (KAZ954+PDR001) and 20 weeks (KAZ954+NIR178)

Secondary Outcomes (16)

  • Overall Response Rate (ORR) per RECIST v1.1

    Up to approximately 48 weeks (KAZ954 single agent), 16 weeks (KAZ954+PDR001) and 20 weeks (KAZ954+NIR178)

  • Overall Response Rate (ORR) per iRECIST

    Up to approximately 48 weeks (KAZ954 single agent), 16 weeks (KAZ954+PDR001) and 20 weeks (KAZ954+NIR178)

  • Disease Control Rate (DCR) per RECIST v1.1

    Up to approximately 48 weeks (KAZ954 single agent), 16 weeks (KAZ954+PDR001) and 20 weeks (KAZ954+NIR178)

  • Disease Control Rate (DCR) per iRECIST

    Up to approximately 48 weeks (KAZ954 single agent), 16 weeks (KAZ954+PDR001) and 20 weeks (KAZ954+NIR178)

  • Progression-Free Survival (PFS) per RECIST v1.1

    Up to approximately 52 weeks (KAZ954 single agent), 20 weeks (KAZ954+PDR001) and 24 weeks (KAZ954+NIR178)

  • +11 more secondary outcomes

Study Arms (4)

Arm A

EXPERIMENTAL

KAZ954

Drug: KAZ954

Arm B

EXPERIMENTAL

KAZ954 + PDR001

Drug: KAZ954Drug: PDR001

Arm C

EXPERIMENTAL

KAZ954 + NIR178

Drug: KAZ954Drug: NIR178

Arm D

EXPERIMENTAL

KAZ954 + NZV930

Drug: KAZ954Drug: NZV930

Interventions

KAZ954DRUG

KAZ954 will be administered in every arm.

Arm AArm BArm CArm D
PDR001DRUG

KAZ954 + PDR001

Arm B
NIR178DRUG

KAZ954 + NIR178

Arm C
NZV930DRUG

KAZ954 + NZV930

Arm D

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University Of California LA

Los Angeles, California, 90095, United States

Location

Yale University Yale Cancer Center

New Haven, Connecticut, 06511, United States

Location

Northwestern University Med School

Chicago, Illinois, 60611, United States

Location

WA Uni School Of Med Dept. of Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

Uni of TX MD Anderson Cancer Cntr

Houston, Texas, 77030, United States

Location

Novartis Investigative Site

Toronto, Ontario, M5G 2M9, Canada

Location

Novartis Investigative Site

Shatin New Territories, Hong Kong, Hong Kong

Location

Novartis Investigative Site

Milan, MI, 20133, Italy

Location

Novartis Investigative Site

Milan, MI, 20162, Italy

Location

Novartis Investigative Site

Sunto Gun, Shizuoka, 411 8777, Japan

Location

Novartis Investigative Site

Singapore, 119074, Singapore

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Taipei, 10002, Taiwan

Location

Related Links

MeSH Terms

Interventions

spartalizumab

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2020

First Posted

January 23, 2020

Study Start

February 20, 2020

Primary Completion

September 15, 2023

Study Completion

September 15, 2023

Last Updated

May 18, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)TW(1)US(5)ES(1)JP(1)IT(2)HK(1)SG(1)