← Back to Search

Other

JDQ443 for Cancer (KontRASt-01 Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

KontRASt-01 Trial Summary

This trial is testing the safety and effectiveness of JDQ443 as a possible treatment for advanced solid tumors.

Who is the study for?

This trial is for adults with advanced solid tumors that have a specific mutation called KRAS G12C. They should have tried standard treatments or be unable to take them, and may have had previous KRAS G12C inhibitor treatment. Participants need at least one tumor that can be measured and must be fairly active and able to care for themselves.Check my eligibility

What is being tested?

The study is testing the safety and effectiveness of JDQ443 alone, and in combination with TNO155 or tislelizumab, in patients with certain advanced cancers. It's an early-phase trial where doses are increased until they find the highest dose people can tolerate without severe side effects.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system since tislelizumab boosts immune activity against cancer cells. Other common drug-related issues might involve skin sensitivity to light, fatigue, digestive problems, changes in blood tests or heart complications.

KontRASt-01 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have advanced cancer with a KRAS G12C mutation and can't take standard treatments.

Select...

I am fully active or can carry out light work.

KontRASt-01 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose Escalation: Dose intensity by treatment

Dose Escalation: Frequency of dose interruptions and reductions, by treatment

Dose Escalation: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

+7 more

Secondary outcome measures

Dose Escalation and Expansion: Antidrug antibody (ADA) incidence by treatment

Dose Escalation and Expansion: Best Overall Response (BOR) per RECIST v1.1

Dose Escalation and Expansion: Disease Control Rate (DCR) per RECIST v1.1

+14 more

KontRASt-01 Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm DExperimental Treatment3 Interventions

JDQ443 in combination with TNO155 and tislelizumab

Group II: Arm CExperimental Treatment2 Interventions

JDQ443 in combination with tislelizumab

Group III: Arm BExperimental Treatment2 Interventions

JDQ443 in combination with TNO155

Group IV: Arm AExperimental Treatment1 Intervention

JDQ443

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,856 Previous Clinical Trials

4,197,230 Total Patients Enrolled

Media Library

JDQ443 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04699188 — Phase 1 & 2

Solid Tumors Research Study Groups: Arm A, Arm B, Arm C, Arm D

Solid Tumors Clinical Trial 2023: JDQ443 Highlights & Side Effects. Trial Name: NCT04699188 — Phase 1 & 2

JDQ443 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04699188 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many different medical facilities can patients participate in this clinical trial?

"In addition to other locations, this particular clinical trial is based out of Emory University School of Medicine/Winship Cancer Institute Winship Cancer Center (Atlanta, Georgia), Providence Cancer Center (Portland, Oregon), and Emory University School of Medicine/Winship Cancer Institute (Boston, Massachusetts)."

Answered by AI

Has a study like this ever been done before?

"JDQ443 has had a long research journey, with the first trials starting back in 2011. These early studies were sponsored by Novartis Pharmaceuticals and only involved 185 patients. However, this was enough to gain Phase 1 drug approval. Now, there are 27 active studies being conducted in 121 cities across 35 countries."

Answered by AI

How many total people are being asked to participate in this research project?

"In order to move forward, this study requires 425 individuals that meet the pre-established inclusion criteria. Currently, there are Emory University School of Medicine/Winship Cancer Institute Winship Cancer Center in Atlanta, Georgia and Providence Cancer Center in Portland, Oregon enrolling patients for this trial."

Answered by AI

Are patients still being actively recruited for this clinical trial?

"From what is noted on clinicaltrials.gov, this study is looking for more participants and was last updated on 10/6/2022. It was originally posted nearly a year ago on 2/24/2021."

Answered by AI

Is this the first time that JDQ443 has been studied?

"The drug JDQ443 was first researched in 2011 at the UCLA School of Medicine. In the decade since, there have been 22 completed trials and 27 more are currently underway. A large number of these active clinical trials are being conducted out of Atlanta, Georgia."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

2021. "Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04699188.

All > Non Small Cell Lung Cancer