What side effects are associated with this type of intervention?

Common treatments for solid tumors, including those similar to JDQ443 (KRAS G12C inhibitors), often result in side effects such as gastrointestinal issues (diarrhea, nausea), dermatologic reactions (rash, alopecia), metabolic disturbances (hyperglycemia), and hematologic toxicities (anemia, neutropenia). Immune checkpoint inhibitors, another common treatment, can also cause immune-related adverse events like pneumonitis and colitis.

What prior FDA approvals exist?

The FDA has approved several treatments for solid tumors, particularly those targeting specific genetic mutations. For instance, KRAS G12C inhibitors like sotorasib have been approved for the treatment of non-small cell lung cancer (NSCLC) with the KRAS G12C mutation. These targeted therapies represent a significant advancement in the treatment of solid tumors by focusing on specific genetic alterations, similar to the investigational drug JDQ443 being studied for advanced solid tumors harboring the KRAS G12C mutation.

What other types of research exist?

Promising alternatives to JDQ443 for solid tumors with KRAS G12C mutation include sotorasib and adagrasib. Both have shown efficacy in clinical trials and are being actively studied for various solid tumors.

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KRAS G12C Inhibitor

JDQ443 Combinations for Advanced Cancer (KontRASt-03 Trial)

Phase 1 & 2

Waitlist Available

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

Must not have

Insufficient bone marrow, hepatic or renal function at screening

Active brain metastases, including symptomatic brain metastases or known leptomeningeal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests JDQ443, a new drug, combined with other treatments for patients with advanced cancers having the KRAS G12C mutation. The drug aims to stop cancer growth by targeting a specific genetic fault.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My liver, kidneys, or bone marrow are not working well.

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I have active brain cancer spread.

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I have heart problems or risk factors for heart disease.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2018

Completed Phase 2

~260

Ribociclib

2018

Completed Phase 3

~2420

cetuximab

2000

Completed Phase 3

~7290

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for solid tumors often involve targeted therapies that focus on specific genetic mutations within cancer cells. For instance, JDQ443 is a KRAS G12C inhibitor that targets a specific mutation in the KRAS gene, which is known to drive cancer growth in various solid tumors. By inhibiting this mutation, JDQ443 can effectively block the signaling pathways that promote tumor proliferation and survival. This precision in targeting allows for more effective treatment with potentially fewer side effects compared to traditional chemotherapy. For patients with solid tumors, such targeted therapies offer a promising approach to manage their disease, especially when conventional treatments have failed.

Breast Cancer Resistance to Cyclin-Dependent Kinases 4/6 Inhibitors: Intricacy of the Molecular Mechanisms.Protein kinase inhibitors for the treatment of prostate cancer.Regorafenib plus best supportive care versus placebo plus best supportive care in Asian patients with previously treated metastatic colorectal cancer (CONCUR): a randomised, double-blind, placebo-controlled, phase 3 trial.