Solid TumorsEarly Phase 1NCT04237649
KAZ954 Alone and With PDR001, NZV930 and NIR178 in Advanced Solid Tumors
A Early Phase 1 study testing KAZ954, PDR001 and NIR178 in people with Solid Tumors, run by Novartis Pharmaceuticals at 13 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- KAZ954, PDR001 and NIR178
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 13 sitesin 8 countries
- Study dates
- 20 Feb 2020to 15 Sep 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 8 countries.
13 sites in 8 countries
United States5 sites
Northwestern University Med School
Chicago, Illinois, 60611
Uni of TX MD Anderson Cancer Cntr
Houston, Texas, 77030
University Of California LA
Los Angeles, California, 90095
Yale University Yale Cancer Center
New Haven, Connecticut, 06511
WA Uni School Of Med Dept. of Siteman Cancer Center
St Louis, Missouri, 63110
Italy2 sites
Novartis Investigative Site
Milan, MI, 20133
Novartis Investigative Site
Milan, MI, 20162
Hong Kong1 site
Novartis Investigative Site
Shatin New Territories, Hong Kong
About this study
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
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.
Read the detailed description
The purpose of this trial was 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 consisted of a dose escalation part and a dose expansion part testing KAZ954 as a single agent or KAZ954 in combination with PDR001, NZV930 and NIR178.
The dose escalation part estimated the MTD and/or RD and tested different dosing schedules. The dose escalation arm KAZ954 + NZV930 was not opened.
The dose expansion part of the study was planned to 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. The dose expansion part of the study was not started.
- Conditions
- Solid Tumors
- Being tested
- KAZ954, PDR001, NIR178, NZV930
- Keywords
- Solid Tumors, KAZ954, PDR001, Spartalizumab, NIR178, NZV930, Immunotherapy, Phase I/Ib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KAZ954Drug
KAZ954 will be administered in every arm.
PDR001Drug
KAZ954 + PDR001
NIR178Drug
KAZ954 + NIR178
NZV930Drug
KAZ954 + NZV930
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | KAZ954 Receives: Drug: KAZ954 |
| Arm B | Experimental | KAZ954 + PDR001 Receives: Drug: KAZ954; Drug: PDR001 |
| Arm C | Experimental | KAZ954 + NIR178 Receives: Drug: KAZ954; Drug: NIR178 |
| Arm D | Experimental | KAZ954 + NZV930 Receives: Drug: KAZ954; Drug: NZV930 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR), based on local investigator assessment per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1. For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Measured: Up to approximately 48 weeks (KAZ954 single agent), 16 weeks (KAZ954+PDR001) and 20 weeks (KAZ954+NIR178)
Overall Response Rate (ORR) per iRECIST
ORR is the percentage of patients with a best overall response of complete response (iCR) or partial response (iPR), based on local investigator assessment per immune-related RECIST (iRECIST). For iRECIST, the principles used to determine objective tumor response are largely unchanged from RECIST v1.1, while the major change of iRECIST is the concept of 'resetting the bar' if RECIST v1.1 progression is followed by tumor shrinkage. Unlike RECIST v1.1, iRECIST requires the confirmation of progression.
Measured: 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
DCR is the percentage of patients with a best overall response of complete response (CR), partial response (PR) or stable disease (SD), based on local investigator assessment per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1. For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression.
Measured: Up to approximately 48 weeks (KAZ954 single agent), 16 weeks (KAZ954+PDR001) and 20 weeks (KAZ954+NIR178)
Disease Control Rate (DCR) per iRECIST
DCR is the percentage of patients with a best overall response of complete response (iCR), partial response (iPR), stable disease (iSD), based on local investigator assessment per immune-related RECIST (iRECIST). For iRECIST, the principles used to determine objective tumor response are largely unchanged from RECIST v1.1, while the major change of iRECIST is the concept of 'resetting the bar' if RECIST v1.1 progression is followed by tumor shrinkage. Unlike RECIST v1.1, iRECIST requires the confirmation of progression.
Measured: 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
For assessment per RECIST v1.1, PFS is the time from date of start of treatment to the date of event defined as the first progression or death due to any cause. If a subject had not had an event, PFS was censored at the date of last adequate tumor assessment. PFS was analyzed using the Kaplan-Meier method.
Measured: Up to approximately 52 weeks (KAZ954 single agent), 20 weeks (KAZ954+PDR001) and 24 weeks (KAZ954+NIR178)
Progression-Free Survival (iPFS) per iRECIST
For assessment per iRECIST, iPFS is the time from date of start of treatment to the date of event defined as the first documented confirmed progression or death due to any cause. If a subject had not had an event, iPFS was censored at the date of last adequate tumor assessment. PFS was analyzed using the Kaplan-Meier method.
Measured: Up to approximately 52 weeks (KAZ954 single agent), 20 weeks (KAZ954+PDR001) and 24 weeks (KAZ954+NIR178)
Maximum observed serum concentration (Cmax) of KAZ954
Pharmacokinetic (PK) parameters were calculated based on free KAZ954 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed concentration following a dose.
Measured: Cycle 1 Day 1 (C1D1) and Cycle 3 Day 1 (C3D1): pre-dose, 1, 24, 72, 168, 240 and 360 hours after the end of the infusion. The duration of the infusion was 2 hours. One cycle=28 days
Maximum observed serum concentration (Cmax) of PDR001
PK parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed concentration following a dose.
Measured: Cycle 1 Day 1 (C1D1) and Cycle 3 Day 1 (C3D1): pre-dose, 1, 168, 336 and 672 hours after the end of the infusion. The duration of the infusion was 30 minutes. One cycle=28 days
Maximum observed plasma concentration (Cmax) of NIR178 and its metabolite NJI765
PK parameters were calculated based on NIR178 and NJI765 plasma concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed concentration following a dose.
Measured: Cycle 1 Day 1 (C1D1) and Cycle 2 Day 1 (C2D1): pre-dose, 15 minutes, 1, 2, 4 and 6 hours after morning dose and 12 hours after evening dose. One cycle=28 days
Area under the serum concentration-time curve from time zero to 14 days post dose (AUC0-14d) of KAZ954
PK parameters were calculated based on free KAZ954 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for area under the curve (AUC) calculation.
Measured: Cycle 1 Day 1 (C1D1) and Cycle 3 Day 1 (C3D1): pre-dose, 1, 24, 72, 168, 240 and 360 hours after the end of the infusion. The duration of the infusion was 2 hours. One cycle=28 days
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) of PDR001
PK parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation.
Measured: Cycle 1 Day 1 (C1D1) and Cycle 3 Day 1 (C3D1): pre-dose, 1, 168, 336 and 672 hours after the end of the infusion. The duration of the infusion was 30 minutes. One cycle=28 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) of NIR178 and its metabolite NJI765
PK parameters were calculated based on NIR178 and NJI765 plasma concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation.
Measured: Cycle 1 Day 1 (C1D1) and Cycle 2 Day 1 (C2D1): pre-dose, 15 minutes, 1, 2, 4 and 6 hours after morning dose and 12 hours after evening dose. One cycle=28 days
Number of participants with anti-KAZ954 antibodies
KAZ954 immunogenicity was evaluated in serum samples. Patient anti-drug antibodies (ADA) status was defined as follows:
- ADA-negative at baseline: ADA-negative sample at baseline
- ADA-positive at baseline: ADA-positive sample at baseline
- ADA-negative post-baseline: ADA-negative sample at baseline and at least 1 post-baseline sample, all of which are ADA-negative samples
- Treatment-reduced ADA-positive: ADA-positive sample at baseline and at least 1 post-baseline sample, all of which are ADA-negative samples
- Treatment-induced ADA-positive: ADA-negative sample at baseline and at least 1 treatment-induced ADA-positive sample
- Treatment-boosted ADA-positive: ADA-positive sample at baseline and at least 1 treatment-boosted ADA-positive sample
Measured: Baseline (before first dose) and post-baseline (assessed throughout the treatment, up to approximately 48 weeks, 16 weeks and 20 weeks for KAZ954 single agent, KAZ954+PDR001 and KAZ954+NIR178, respectively)
Number of participants with anti-PDR001 antibodies
PDR001 immunogenicity was evaluated in serum samples. Patient anti-drug antibodies (ADA) status was defined as follows:
- ADA-negative at baseline: ADA-negative sample at baseline
- ADA-positive at baseline: ADA-positive sample at baseline
- ADA-negative post-baseline: ADA-negative sample at baseline and at least 1 post-baseline sample, all of which are ADA-negative samples
- Treatment-reduced ADA-positive: ADA-positive sample at baseline and at least 1 post-baseline sample, all of which are ADA-negative samples
- Treatment-induced ADA-positive: ADA-negative sample at baseline and at least 1 treatment-induced ADA-positive sample
- Treatment-boosted ADA-positive: ADA-positive sample at baseline and at least 1 treatment-boosted ADA-positive sample
Measured: Baseline (before first dose) and post-baseline (assessed throughout the treatment, up to approximately 16 weeks)
Overall Response Rate (ORR) using RECIST v1.1 and iRECIST by PD-L1 expression
Programmed Death-Ligand 1 (PD-L1) expression was assessed centrally using the 22C3 PharmDx assay. PD-L1 expression levels were defined based on the tumor proportion score (TPS). The PD-L1 expression levels were categorized as high (TPS ≥ 50%), medium (TPS 1% - 49%) and low (TPS <1%) expressors. ORR using RECIST v1.1 and iRECIST was summarized by PD-L1 expression.
Measured: Up to approximately 48 weeks (KAZ954 single agent), 16 weeks (KAZ954+PDR001) and 20 weeks (KAZ954+NIR178)
Progression Free Survival (PFS) using RECIST v1.1 and iRECIST by PD-L1 expression
Programmed Death-Ligand 1 (PD-L1) expression was assessed centrally using the 22C3 PharmDx assay. PD-L1 expression levels were defined based on the tumor proportion score (TPS). The PD-L1 expression levels were categorized as high (TPS ≥ 50%), medium (TPS 1% - 49%) and low (TPS <1%) expressors. PFS using RECIST v1.1 and iRECIST was summarized by PD-L1 expression.
Measured: Up to approximately 52 weeks (KAZ954 single agent), 20 weeks (KAZ954+PDR001) and 24 weeks (KAZ954+NIR178)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start20 Feb 2020
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Why it stopped: Business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237649
- Sponsor's protocol ID
- CKAZ954A12101
- Other IDs
- 2019-002841-39, 2019
- Status last verified
- May 2025
- First submitted
- 17 Jan 2020
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04237649
- Acronym / sponsor ID
- CKAZ954A12101
- Conditions
- Solid Tumors
- Keywords
- Solid Tumors, KAZ954, PDR001, Spartalizumab, NIR178, NZV930, Immunotherapy, Phase I/Ib
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business reasons
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this trial was 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 consisted of a dose escalation part and a dose expansion part testing KAZ954 as a single agent or KAZ954 in combination with PDR001, NZV930 and NIR178.
The dose escalation part estimated the MTD and/or RD and tested different dosing schedules. The dose escalation arm KAZ954 + NZV930 was not opened.
The dose expansion part of the study was planned to 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. The dose expansion part of the study was not started.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: KAZ954KAZ954 |
| Arm B | Experimental | Drug: KAZ954, Drug: PDR001KAZ954 + PDR001 |
| Arm C | Experimental | Drug: KAZ954, Drug: NIR178KAZ954 + NIR178 |
| Arm D | Experimental | Drug: KAZ954, Drug: NZV930KAZ954 + NZV930 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KAZ954KAZ954 will be administered in every arm. | Drug | Arm A, Arm B, Arm C, Arm D |
| PDR001KAZ954 + PDR001 | Drug | Arm B |
| NIR178KAZ954 + NIR178 | Drug | Arm C |
| NZV930KAZ954 + NZV930 | Drug | Arm D |
Primary outcome
Incidence of Dose Limiting Toxicities (DLTs)
Time frame: Up to 35 days
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.
Incidence of adverse events and serious adverse events during the on-treatment period
Time frame: Up to approximately 52 weeks (KAZ954 single agent), 20 weeks (KAZ954+PDR001) and 24 weeks (KAZ954+NIR178)
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.
Number of participants with dose interruptions and dose reductions
Time frame: Up to approximately 48 weeks (KAZ954 single agent), 16 weeks (KAZ954+PDR001) and 20 weeks (KAZ954+NIR178)
Number of participants with at least one dose interruption or reduction of KAZ954 and its combination partners during study treatment to assess tolerability.
Dose intensity of study treatment
Time frame: Up to approximately 48 weeks (KAZ954 single agent), 16 weeks (KAZ954+PDR001) and 20 weeks (KAZ954+NIR178)
Dose intensity of KAZ954 and its combination partners computed as the ratio of actual cumulative dose received and actual duration of exposure.
16 secondary outcomes
Overall Response Rate (ORR) per RECIST v1.1
Time frame: Up to approximately 48 weeks (KAZ954 single agent), 16 weeks (KAZ954+PDR001) and 20 weeks (KAZ954+NIR178)
Overall Response Rate (ORR) per iRECIST
Time frame: 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
Time frame: Up to approximately 48 weeks (KAZ954 single agent), 16 weeks (KAZ954+PDR001) and 20 weeks (KAZ954+NIR178)
Disease Control Rate (DCR) per iRECIST
Time frame: 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
Time frame: Up to approximately 52 weeks (KAZ954 single agent), 20 weeks (KAZ954+PDR001) and 24 weeks (KAZ954+NIR178)
Progression-Free Survival (iPFS) per iRECIST
Time frame: Up to approximately 52 weeks (KAZ954 single agent), 20 weeks (KAZ954+PDR001) and 24 weeks (KAZ954+NIR178)
Maximum observed serum concentration (Cmax) of KAZ954
Time frame: Cycle 1 Day 1 (C1D1) and Cycle 3 Day 1 (C3D1): pre-dose, 1, 24, 72, 168, 240 and 360 hours after the end of the infusion. The duration of the infusion was 2 hours. One cycle=28 days
Maximum observed serum concentration (Cmax) of PDR001
Time frame: Cycle 1 Day 1 (C1D1) and Cycle 3 Day 1 (C3D1): pre-dose, 1, 168, 336 and 672 hours after the end of the infusion. The duration of the infusion was 30 minutes. One cycle=28 days
Maximum observed plasma concentration (Cmax) of NIR178 and its metabolite NJI765
Time frame: Cycle 1 Day 1 (C1D1) and Cycle 2 Day 1 (C2D1): pre-dose, 15 minutes, 1, 2, 4 and 6 hours after morning dose and 12 hours after evening dose. One cycle=28 days
Area under the serum concentration-time curve from time zero to 14 days post dose (AUC0-14d) of KAZ954
Time frame: Cycle 1 Day 1 (C1D1) and Cycle 3 Day 1 (C3D1): pre-dose, 1, 24, 72, 168, 240 and 360 hours after the end of the infusion. The duration of the infusion was 2 hours. One cycle=28 days
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) of PDR001
Time frame: Cycle 1 Day 1 (C1D1) and Cycle 3 Day 1 (C3D1): pre-dose, 1, 168, 336 and 672 hours after the end of the infusion. The duration of the infusion was 30 minutes. One cycle=28 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) of NIR178 and its metabolite NJI765
Time frame: Cycle 1 Day 1 (C1D1) and Cycle 2 Day 1 (C2D1): pre-dose, 15 minutes, 1, 2, 4 and 6 hours after morning dose and 12 hours after evening dose. One cycle=28 days
Number of participants with anti-KAZ954 antibodies
Time frame: Baseline (before first dose) and post-baseline (assessed throughout the treatment, up to approximately 48 weeks, 16 weeks and 20 weeks for KAZ954 single agent, KAZ954+PDR001 and KAZ954+NIR178, respectively)
Number of participants with anti-PDR001 antibodies
Time frame: Baseline (before first dose) and post-baseline (assessed throughout the treatment, up to approximately 16 weeks)
Overall Response Rate (ORR) using RECIST v1.1 and iRECIST by PD-L1 expression
Time frame: Up to approximately 48 weeks (KAZ954 single agent), 16 weeks (KAZ954+PDR001) and 20 weeks (KAZ954+NIR178)
Progression Free Survival (PFS) using RECIST v1.1 and iRECIST by PD-L1 expression
Time frame: Up to approximately 52 weeks (KAZ954 single agent), 20 weeks (KAZ954+PDR001) and 24 weeks (KAZ954+NIR178)
Results and safety
The study was stopped early (reason given: Business reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Study ResultsLink provided by the sponsor.
- A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
13 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing KAZ954, PDR001 and NIR178 in people with Solid Tumors, run by Novartis Pharmaceuticals at 13 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Italy, Canada, Hong Kong, Japan and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose Limiting Toxicities (DLTs) (time frame: Up to 35 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.