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Clinical Trials in Spain / NCT05358249
Active, not recruiting Phase 1/2

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

NCT05358249 · tracked via the Priya Life Science Spain tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 1/2
Started
2022-10-24
Last updated
2026-06-15

Condition(s) studied

KRAS G12C Mutant Solid TumorsCarcinoma, Non-Small Cell LungCarcinoma, Non-Small-Cell LungNon-Small Cell Lung CancerNon-Small Cell Lung CarcinomaNonsmall Cell Lung CancerColorectal CancerColorectal CarcinomaColorectal NeoplasmsColorectal TumorsNeoplasms, Colorectal

Investigational drug(s) / intervention(s)

JDQ443 →trametinib →Ribociclib →cetuximab →

JDQ443: KRAS G12C inhibitor, oral

trametinib: MEK inhibitor, oral

Ribociclib: CDK4/6 inhibitor, oral

cetuximab: EGFR inhibitor, intravenous

Study summary

This is Phase Ib/II, multicenter, open-label adaptive platform study of JDQ443 with select therapies in patients with advanced solid tumors harboring the KRAS G12C mutation.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: Dose Escalation: \- Patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received standard of care therapy or are ineligible to receive such therapy. Phase II: * Patients with advanced (metastatic or unresectable) KRAS G12C mutant non-small cell lung cancer who have received platinum-based chemotherapy regimen and immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy * 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: * ECOG performance status of 0 or 1. * Patients must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines. Exclusion Criteria: * Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutations * Prior treatment with a KRAS G12C inhibitor is excluded for patients in a subset of groups in Phase II. * Active brain metastases, including symptomatic brain metastases or known leptomeningeal disease * Clinically significant cardiac disease or risk factors at screening * Insufficient bone marrow, hepatic or renal function at screening Other protocol-defined inclusion/exclusion criteria may apply

Primary outcome measure(s)

  • Dose escalation: Incidence and severity of dose limiting toxicities (DLTs) of each combination treatment. — 28 days
    A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value that is not primarily related to disease, disease progression, intercurrent illness/injury, or concomitant medications that occurs within the first 28 days of study treatment and meets a defined criteria.
  • Dose escalation: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) by treatment — 24 months
    All information obtained on AE will be displayed by treatment group. Summary tables will include only AEs that started/worsened during the cycles of treatment (treatment-emergent AEs).
  • Dose escalation: Frequency of dose interruptions and reductions, by treatment — 24 months
    The number of patients with dose adjustments (reductions and interruptions) will be summarized by treatment group.
  • Dose Escalation: Dose intensity by treatment — 24 months
    Dose intensity is defined as the ratio of actual cumulative dose received and actual duration of response.
  • PhaseII: Overall Response Rate by Blinded Independent Review Committee (BIRC) per RECIST 1.1 — 24 months
    ORR is the proportion of patients with a best overall response (BOR) of Complete Response (CR) or Partial Response (PR).

Trial sites (13)

FacilityCityRegionStatus
Massachusetts General Hospital Boston Massachusetts
Dana Farber Cancer Institute Boston Massachusetts
NYU School of Medicine New York New York
Novartis Investigative Site Leuven Belgium
Novartis Investigative Site Bordeaux France
Novartis Investigative Site Lyon France
Novartis Investigative Site Freiburg im Breisgau Baden-Wurttemberg
Novartis Investigative Site Milan MI
Novartis Investigative Site Singapore Singapore
Novartis Investigative Site Seoul South Korea
Novartis Investigative Site Barcelona Spain
Novartis Investigative Site Madrid Spain
Novartis Investigative Site Madrid Spain

On this site

📄 Kisqali (ribociclib) drug profile →

More Novartis Pharmaceuticals trials in Spain

Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease Active, not recruiting
A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor. Active, not recruiting
An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Active, not recruiting
A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis (ALS) Active, not recruiting
Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer Active, not recruiting

Other trials for the same condition

Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers Active, not recruiting
Comparing Polypropylene Mesh and "Small Bites" Technique in Emergency Colorectal Surgery's Midline Laparotomy Closure. Study for Incisional Hernia Prevention. Recruiting
Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104). Active, not recruiting
A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015) Recruiting
Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05358249 on ClinicalTrials.gov ↗ ← All trials in Spain