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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 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.

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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.

Conditions Studied

Lung Cancer Carcinoma, Non-Small Cell Lung Cancer of the Lung Pulmonary Cancer Neoplasms, Lung Neoplasms, Pulmonary Cancer of Lung Carcinoma, Colorectal KRAS G12C Mutant Solid Tumors Pulmonary Neoplasms

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

FieldValue
Enrollment Target 344 participants
Start Date 2021-02-24
Est. Completion 2027-01-25
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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What the Registry Record Tells You About NCT04699188

The ClinicalTrials.gov registry entry for NCT04699188 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 344 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 935-participant average among 409 other Lung Cancer trials with a reported enrollment target (63% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.