Suspended

KontRASt-01JDQ443 Treatment for Advanced Solid Tumors with KRAS G12C Mutation

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Study Aim

This study aims to evaluate the safety, tolerability, and effectiveness of JDQ443 treatment in adults with advanced solid tumors carrying the KRAS G12C mutation, primarily focusing on dose intensity, frequency of dose interruptions and reductions, incidence of adverse events, and overall response rate.

What is being tested

JDQ443

+ TNO155

+ tislelizumab

DrugBiological
Who is being recruted

Bronchial Neoplasms+20

+ Carcinoma, Bronchogenic

+ Carcinoma, Non-Small-Cell Lung

From 18 to 100 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: February 2021
See protocol details

Summary

Principal SponsorNovartis Pharmaceuticals
Last updated: March 19, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 24, 2021

Actual date on which the first participant was enrolled.

This study focuses on patients with advanced solid tumors that have a specific mutation known as KRAS G12C. The main goal is to test the safety and effectiveness of a drug called JDQ443, both alone and in combination with other treatments (TNO155 and tislelizumab). The study is important as it aims to find the best dose of these treatments for patients with this specific type of tumor, which could potentially improve their care and address the current challenges in treating advanced solid tumors. During the study, participants will receive the treatments and the researchers will monitor their response. The study measures the results by looking at how well the treatments are tolerated, how often the dose needs to be adjusted, and the frequency of side effects. It also evaluates how well the treatments shrink the tumors. The potential risks include side effects from the treatments, but the researchers will closely monitor these. The potential benefits could be a reduction in tumor size or improved quality of life.

Official TitleA Phase Ib/II Open-label, Multi-center Dose Escalation Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
NCT04699188
Principal SponsorNovartis Pharmaceuticals
Last updated: March 19, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

344 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungColonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsLung DiseasesLung NeoplasmsNeoplasm MetastasisNeoplasmsNeoplasms by SiteNeoplastic ProcessesPathologic ProcessesRectal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsPathological Conditions, Signs and SymptomsThoracic NeoplasmsColorectal Neoplasms

Criteria

4 inclusion criteria required to participate
Adult patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received standard of care or are intolerant or ineligible to approved therapies
ECOG Performance Status of 0 or 1
At least one measurable lesion as defined by RECIST 1.1
Prior treatment with a KRAS G12C inhibitor may be allowed for dose escalations of combinations and a subset of groups in dose expansion
4 exclusion criteria prevent from participating
Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutations
Symptomatic brain metastases or known leptomeningeal disease. Patients with asymptomatic treated or untreated brain metastases may be eligible
Clinically significant cardiac disease or risk factors at screening
A medical condition that results in increased photosensitivity

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
JDQ443

Group II

Experimental
JDQ443 in combination with TNO155

Group III

Experimental
JDQ443 in combination with tislelizumab

Group IV

Experimental
JDQ443 in combination with TNO155 and tislelizumab

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 38 locations

Suspended

Novartis Investigative Site

Chuo Ku, JapanOpen Novartis Investigative Site in Google Maps
Suspended

Emory University School of Medicine-Winship Cancer Institute

Atlanta, United States
Suspended

Massachusetts General Hospital Cancer Center

Boston, United States
Suspended

Massachusetts General Hospital

Boston, United States
Suspended38 Study Centers