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KRAS G12C Inhibitor

JDQ443 Combinations for Advanced Cancer (KontRASt-03 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

Phase II: Patients with advanced (metastatic or unresectable) KRAS G12C mutant colorectal cancer who have received fluropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, unless patient was ineligible to such therapy

All patients: Patients must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

KontRASt-03 Trial Summary

This trialstudies how well new treatments work in people with advanced cancer with a specific gene mutation.

Who is the study for?

This trial is for adults with advanced solid tumors that have a specific mutation called KRAS G12C. It's open to those who've had standard treatments or can't receive them, and they should be able to undergo a tumor biopsy. People with poor organ function, active brain metastases, significant heart issues, or prior treatment with KRAS G12C inhibitors (in some cases) are excluded.Check my eligibility

What is being tested?

The study is testing JDQ443 in combination with other drugs like trametinib, ribociclib, and cetuximab on patients whose tumors have the KRAS G12C mutation. This adaptive platform study will adjust based on results as it progresses through phases Ib/II.See study design

What are the potential side effects?

Potential side effects may include typical reactions from cancer therapies such as fatigue, skin changes, digestive disturbances (like diarrhea), liver enzyme alterations leading to potential liver damage, blood count variations which could affect immunity and clotting.

KontRASt-03 Trial Eligibility Criteria

Inclusion Criteria

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

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I have advanced colorectal cancer with a specific mutation and have been treated with certain chemotherapies.

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I can have a biopsy based on my hospital's rules.

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I am fully active or can carry out light work.

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My cancer is advanced with a KRAS G12C mutation and I've had or can't have standard treatment.

KontRASt-03 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) by treatment

+2 more

Secondary outcome measures

Dose escalation and Phase II: Disease Control Rate (DCR) by local review per RECIST 1.1

Dose escalation and Phase II: Duration of Response (DoR) by local review per RECIST 1.1

Dose escalation and Phase II: ORR by local review per RECIST 1.1

+13 more

KontRASt-03 Trial Design

3Treatment groups

Experimental Treatment

Group I: JDQ443+trametinibExperimental Treatment2 Interventions

JDQ443 in combination with trametinib

Group II: JDQ443+ribociclibExperimental Treatment2 Interventions

JDQ443 in combination with ribociclib

Group III: JDQ443+cetuximabExperimental Treatment2 Interventions

JDQ443 in combination with cetuximab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

trametinib

2012

Completed Phase 2

~200

Ribociclib

2018

Completed Phase 3

~2330

cetuximab

2000

Completed Phase 3

~7290

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,855 Previous Clinical Trials

4,197,041 Total Patients Enrolled

Media Library

JDQ443 (KRAS G12C Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05358249 — Phase 1 & 2

Solid Tumors Research Study Groups: JDQ443+trametinib, JDQ443+ribociclib, JDQ443+cetuximab

Solid Tumors Clinical Trial 2023: JDQ443 Highlights & Side Effects. Trial Name: NCT05358249 — Phase 1 & 2

JDQ443 (KRAS G12C Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05358249 — Phase 1 & 2

Frequently Asked Questions

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

Is there still room for participants in this research?

"Affirmative. According to the information posted on clinicaltrials.gov, recruitment for this trial is currently underway. Initial postings were made in January of 2022 and a subsequent update was done nine months later in September 2023. The study seeks 346 participants from two different sites."

Answered by AI

What is the current cohort size for this research endeavor?

"Affirmative. Clinicaltrials.gov data indicates that this experiment, which was originally published on May 1st 2022, is actively seeking participants. Approximately 346 individuals need to be sourced from two different research sites."

Answered by AI

What is the purpose of this clinical research endeavor?

"Novartis Pharmaceuticals, the trial sponsor, states that the primary endpoint of this two year long study is Dose escalation: Incidence and severity of dose limiting toxicities (DLTs) for each treatment regimen. As secondary outcomes, researchers will consider Dose escalation and Phase II Disease Control Rate (DCR) by local review per RECIST 1.1 which measures tumor shrinkage or slowing down as signs of activity; Tmax-Cmax time to achieve maximum plasma drug concentration after single dose administration; and DCR by BIRC per RECIST 1.1 measuring tumor response in a similar fashion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05358249.

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