Active — Not RecruitingPhase 1/2

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

United States, Australia, Belgium344 participantsStarted 2021-02-24

Plain-language 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.

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 Other protocol-defined inclusion/exclusion criteria may apply.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dose Escalation: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of monotherapy or combination treatment

Timeframe: 21 days

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

Timeframe: 24 months

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

Timeframe: 24 months

Dose Escalation: Dose intensity by treatment

Timeframe: 24 months

Dose Expansion: Overall response rate (ORR) per RECIST v1.1, by treatment

Timeframe: 24 months

Dose expansion: Overall intracranial response rate (OIRR) per mRANO-BM

Timeframe: 24 months

Dose expansion: Incidence and severity of AEs and SAEs

Timeframe: 24 months

Trial details

NCT IDNCT04699188

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01-25

View on ClinicalTrials.gov More KRAS G12C Mutant Solid Tumors trials

Plain-language summary

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Dose Escalation: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of monotherapy or combination treatment

Timeframe: 21 days

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

Timeframe: 24 months

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

Timeframe: 24 months

Dose Escalation: Dose intensity by treatment

Timeframe: 24 months

Dose Expansion: Overall response rate (ORR) per RECIST v1.1, by treatment

Timeframe: 24 months

Dose expansion: Overall intracranial response rate (OIRR) per mRANO-BM

Timeframe: 24 months

Dose expansion: Incidence and severity of AEs and SAEs

Timeframe: 24 months