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NCT04699188 · ClinicalTrials.gov registry record · Phase 1
Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
A Phase 1 study of Lung Cancer and Carcinoma, Non-Small Cell Lung, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 1
- Development phase
- 344
- Enrollment target
- 20
- Study locations
NCT04699188: Active Phase 1 study of Lung Cancer and Carcinoma, Non-Small Cell Lung, sponsored by Novartis Pharmaceuticals.
NCT04699188 is a Phase 1 study of Lung Cancer and Carcinoma, Non-Small Cell Lung that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 344 participants, below the 935-participant average among 409 other Lung Cancer trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04699188, a Phase 1 study of Lung Cancer and Carcinoma, Non-Small Cell Lung, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 344 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a phase Ib/II open label study. The escalation part will characterize the safety and tolerability of JDQ443 single agent and JDQ443 in combination with the other study treatments (TNO155 and tislelizumab) in advanced solid tumor patients. After the determination of the maximum tolerated dose / recommended dose for a particular treatment arm, dose expansion will assess the anti-tumor activity and further assess the safety, tolerability, and PK/PD of each regimen at the maximum tolerated dose / recommended dose or lower dose.
Primary Outcome
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment
Conditions Studied
Interventions
- DRUG JDQ443
- DRUG TNO155
- BIOLOGICAL tislelizumab
Study Locations (20)
Other
- Novartis Investigative Site - Leuven
- Novartis Investigative Site - Beijing
- Novartis Investigative Site - Copenhagen
- Novartis Investigative Site - Lyon
- Novartis Investigative Site - Marseille
- Novartis Investigative Site - Villejuif
- Novartis Investigative Site - Essen
- Novartis Investigative Site - Hong Kong
Massachusetts
- Massachusetts General Hospital Cancer Center - Boston
- Massachusetts General Hospital - Boston
Georgia
- Emory University School of Medicine-Winship Cancer Institute - Atlanta
Pennsylvania
- Hillman Cancer Center - Pittsburgh
Texas
- Uni Of TX MD Anderson Cancer Cntr - Houston
Victoria
- Novartis Investigative Site - Melbourne
Quebec
- Novartis Investigative Site - Montreal
Guangdong
- Novartis Investigative Site - Guangzhou
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 344 participants |
| Start Date | 2021-02-24 |
| Est. Completion | 2027-01-25 |
| Phase | Phase 1 |
What the registry record for NCT04699188 still lists
NCT04699188 is an interventional study that assigns participants to a tested intervention. The registered 344 participants enrollment target is mid-sized for trials with a published cap, below the 935-participant average among 409 other Lung Cancer trials with a reported enrollment target (63% lower).
The record links to 10 conditions, with Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which JDQ443 is the first listed.
NCT04699188 names 20 study sites across 12 states, led by Other, Massachusetts, Georgia.
Frequently Asked Questions
What is clinical trial NCT04699188 about?
NCT04699188 is a clinical study titled "Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation". This is a phase Ib/II open label study. The escalation part will characterize the safety and tolerability of JDQ443 single agent and JDQ443 in combination with the other study treatments (TNO155 and tislelizumab) in advanced solid tumor patients. After the determination of the maximum tolerated dose...
What is the current status of trial NCT04699188?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 344 participants. The study started on 2021-02-24. Estimated completion is 2027-01-25.
What conditions does trial NCT04699188 study?
This clinical trial studies the following conditions: Lung Cancer, Carcinoma, Non-Small Cell Lung, Cancer of the Lung, Pulmonary Cancer, Neoplasms, Lung.
What interventions are being tested in trial NCT04699188?
The interventions under investigation include: JDQ443 (DRUG), TNO155 (DRUG), tislelizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04699188?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04699188 being conducted?
This trial has 20 study locations across Georgia, Massachusetts, Pennsylvania, Texas, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04699188's enrollment target sits among peer trials
344 93rd of 409 higher than 317 of 409 other Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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