Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04237649 · ClinicalTrials.gov registry record · Early Phase 1
KAZ954 Alone and With PDR001, NZV930 and NIR178 in Advanced Solid Tumors
A Early Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 77
- Enrollment target
NCT04237649: Clinical Trial Early Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT04237649 is a Early Phase 1 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 77 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (45% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04237649, a Early Phase 1 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 77 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG PDR001
- DRUG NIR178
- DRUG KAZ954
- DRUG NZV930
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2020-02-20 |
| Est. Completion | 2023-09-15 |
| Phase | Early Phase 1 |
Why NCT04237649 stopped before completion
NCT04237649 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (45% higher).
The record links to 0 conditions, and to 4 interventions - of which PDR001 is the first listed.
NCT04237649 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04237649 about?
NCT04237649 is a clinical study titled "KAZ954 Alone and With PDR001, NZV930 and NIR178 in 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.
What is the current status of trial NCT04237649?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 77 participants. The study started on 2020-02-20. Estimated completion is 2023-09-15.
What interventions are being tested in trial NCT04237649?
The interventions under investigation include: PDR001 (DRUG), NIR178 (DRUG), KAZ954 (DRUG), NZV930 (DRUG).
Who is sponsoring clinical trial NCT04237649?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04237649's enrollment target sits among peer trials
77 302nd of 2000 higher than 1,698 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02127398 · 77 participants · Phase 2
Stool Transplants to Treat Refractory Clostridium Difficile Colitis
- NCT04159103 · 77 participants · Phase 1
Open-Label Study of mRNA-3927 in Participants With Propionic Acidemia
- NCT04683003 · 77 participants · Phase 3
A Study of TAK-755 in Participants With Congenital Thrombotic Thrombocytopenic Purpura
- NCT05004116 · 77 participants · Phase 1
A Study of Repotrectinib in Combination With Chemotherapy in Children and Young Adults With Solid Tumor Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI