Informations générales (source: ClinicalTrials.gov)
A Phase I, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of AZD9592 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumors
Interventional
Phase 1
AstraZeneca (Voir sur ClinicalTrials)
décembre 2022
octobre 2027
12 septembre 2025
This is a first-in-human (FIH) Phase I, multi-center, open-label, study of AZD9592, in
patients with advanced solid tumors. The study consists of several study modules, each
evaluating the safety, tolerability, preliminary efficacy, pharmacokinetics (PK),
pharmacodynamics, anti-tumor activity, and immunogenicity of AZD9592, as monotherapy or
in combination with anti-cancer agents.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | David PLANCHARD | 25/06/2024 10:12:15 | 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 | |||||
| Research Site - 13385 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Research Site - 35000 - Rennes - France | Contact (sur clinicalTrials) | ||||
| Research Site - 94805 - Villejuif Cedex - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
- Life expectancy ≥ 12 weeks
- Measurable disease per RECIST v1.1
- Adequate organ and marrow function as defined in the protocol
Additional Inclusion Criteria for Module 1:
• Histologically or cytologically confirmed metastatic or locally advanced EGFRmut.,
NSCLC; metastatic EGFRwt. NSCLC; recurrent or metastatic HNSCC of the oral cavity;
metastatic CRC.
Additional Inclusion Criteria for Module 2:
• Histologically or cytologically confirmed metastatic NSCLC EGFRmut.
Additional Inclusion Criteria for Module 3:
• Histologically or cytologically confirmed metastatic CRC.
Key
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
- Life expectancy ≥ 12 weeks
- Measurable disease per RECIST v1.1
- Adequate organ and marrow function as defined in the protocol
Additional Inclusion Criteria for Module 1:
• Histologically or cytologically confirmed metastatic or locally advanced EGFRmut.,
NSCLC; metastatic EGFRwt. NSCLC; recurrent or metastatic HNSCC of the oral cavity;
metastatic CRC.
Additional Inclusion Criteria for Module 2:
• Histologically or cytologically confirmed metastatic NSCLC EGFRmut.
Additional Inclusion Criteria for Module 3:
• Histologically or cytologically confirmed metastatic CRC.
Key
- History of (non-infectious) ILD/pneumonitis that required steroids, has current
ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging
at screening.
- Spinal cord compression or a history of leptomeningeal carcinomatosis.
- Active infection including tuberculosis and HBV, HCV or HIV
- Brain metastases unless treated (prior treatment required only for Module 1),
asymptomatic, stable, and not requiring continuous corticosteroids at a dose of > 10
mg prednisone/day or equivalent for at least 4 weeks prior to start of study
treatment.
- Participants with cardiac comorbidities as defined in the study protocol