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Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
NCT04699188 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04699188
The ClinicalTrials.gov registry entry for NCT04699188 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 344 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04699188 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, Massachusetts, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04699188?
The interventions under investigation include: JDQ443 (DRUG), TNO155 (DRUG), tislelizumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04699188?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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