| TITRE |
(EN) A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 193 in Subjects With Methylthioadenosine Phosphorylase (MTAP)-Deleted Previously Treated Advanced Non-Small Cell Lung Cancer |
| PROTOCOLE ID |
20230153 |
| CLINICAL TRIAL.gov ID |
NCT06593522 |
| TYPE(S) DE CANCER |
Poumon non à petites cellules |
| PHASE |
Phase II |
| TYPE D'ÉTUDE |
Clinique |
| INSTITUTION |
CUSM
1001 boul. Décarie
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Benjamin Shieh
|
| COORDONATEUR(RICE) |
|
| STATUT |
Actif en recrutement
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- Histologically or cytologically confirmed metastatic or unresectable locally advanced MTAP-deleted (Homozygous deletion of MTAP in the tumor tissue) non-small cell lung cancer
- Participants will have received and progressed or experienced disease recurrence on or after receiving at least 1 prior systemic therapy for locally advanced and unresectable or metastatic disease.
- Either an archival tissue sample or an archival block must be available.
- Life expectancy of greater than 3 months, in the opinion of the investigator.
- Participants who have had brain metastases and have been appropriately treated with radiation therapy or surgery ending at least 14 days before study day 1 are eligible.
- Participants with untreated asymptomatic brain metastases smaller or equal to 2 cm in size (per lesion if more than one) and not requiring corticosteroid treatment are eligible.
|
| CRITÈRES D'EXCLUSION |
(EN) Disease Related
- Tumors harboring the following mutations amenable to targeted therapies: epidermal growth factor receptor (EGFR), ALK receptor tyrosine kinase (ALK), ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), MET proto-oncogene (MET), B-Raf proto-oncogene (BRAF), RET proto-oncogene (RET), Human epidermal growth factor receptor 2 (HER2), KRAS proto-oncogene (KRAS).
Other Medical Conditions
- Major surgery within 28 days of study day 1.
- Untreated symptomatic central nervous system (CNS) metastatic disease regardless of size or asymptomatic brain metastases greater than 2 cm per lesion.
|
