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NCT05358249 · ClinicalTrials.gov registry record · Phase 1
Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
A Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
- 13
- Study locations
NCT05358249: Active Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, sponsored by Novartis Pharmaceuticals.
NCT05358249 is a Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 74 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (89% lower). The trial reports 13 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05358249, a Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
- 13
- Study locations
Study Summary
This is Phase Ib/II, multicenter, open-label adaptive platform study of JDQ443 with select therapies in patients with advanced solid tumors harboring the KRAS G12C mutation.
Primary Outcome
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value that is not primarily related to disease, disease progression, intercurrent illness/injury, or concomitant medications that occurs within the first 28 days of study treatment and meets a defined criteria.
Conditions Studied
Interventions
- DRUG trametinib
- DRUG Ribociclib
- BIOLOGICAL cetuximab
- DRUG JDQ443
Study Locations (13)
Other
- Novartis Investigative Site - Leuven
- Novartis Investigative Site - Bordeaux
- Novartis Investigative Site - Lyon
- Novartis Investigative Site - Singapore
- Novartis Investigative Site - Barcelona
- Novartis Investigative Site - Madrid
- Novartis Investigative Site - Madrid
Massachusetts
- Massachusetts General Hospital - Boston
- Dana Farber Cancer Institute - Boston
New York
- NYU School of Medicine - New York
Baden-Wurttemberg
- Novartis Investigative Site - Freiburg im Breisgau
MI
- Novartis Investigative Site - Milan
Korea
- Novartis Investigative Site - Seoul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2022-10-24 |
| Est. Completion | 2026-11-30 |
| Phase | Phase 1 |
What the registry record for NCT05358249 still lists
NCT05358249 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (89% lower).
The record links to 8 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 4 interventions - of which trametinib is the first listed.
NCT05358249 lists 13 locations in 6 states (Other, Massachusetts, New York).
Frequently Asked Questions
What is clinical trial NCT05358249 about?
NCT05358249 is a clinical study titled "Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation". This is Phase Ib/II, multicenter, open-label adaptive platform study of JDQ443 with select therapies in patients with advanced solid tumors harboring the KRAS G12C mutation.
What is the current status of trial NCT05358249?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2022-10-24. Estimated completion is 2026-11-30.
What conditions does trial NCT05358249 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Colorectal Cancer, Carcinoma, Non-Small Cell Lung, Colorectal Neoplasms, Colorectal Carcinoma.
What interventions are being tested in trial NCT05358249?
The interventions under investigation include: trametinib (DRUG), Ribociclib (DRUG), cetuximab (BIOLOGICAL), JDQ443 (DRUG).
Who is sponsoring clinical trial NCT05358249?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05358249 being conducted?
This trial has 13 study locations across Massachusetts, New York, Baden-Wurttemberg, MI, Korea. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05358249's enrollment target sits among peer trials
74 281st of 454 higher than 174 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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.
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