Clinical Trials in Italy / 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 Italy tracker
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: 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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 Italy
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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 Italy