Informations générales (source: ClinicalTrials.gov)
A Phase Ib/II Open-label, Multi-center Dose Escalation Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
Interventional
Phase 1/Phase 2
Novartis Pharmaceuticals (Voir sur ClinicalTrials)
février 2021
août 2026
10 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Fabrice BARLESI | 17/05/2024 13:49:05 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Novartis Investigative Site - 13273 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 69373 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 94800 - Villejuif - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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.