The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted thoracic tumors. The study also aims to determine the safety profile of AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted thoracic tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
Administered PO
Administered IV
Administered IV
Administered IV
Administered IV
Administered PO
Comprehensive Blood and Cancer Center
Bakersfield, California, United States
RECRUITINGCity of Hope National Medical Center
Duarte, California, United States
RECRUITINGCity of Hope Orange County Lennar Foundation Cancer Center
Duarte, California, United States
RECRUITINGTranslational Research in Oncology US Inc, Trio Central Pharmacy
Los Angeles, California, United States
Number of Participants Experiencing Dose Limiting Toxicities (DLT)
Time frame: Up to approximately 21 days
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE)
TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. A serious TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s) that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.
Time frame: Up to approximately 3 years
Number of Participants Experiencing Serious Adverse Events (SAE)
An SAE is defined as any AE that results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgment may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above.
Time frame: Up to approximately 3 years
Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time frame: Up to approximately 3 years
Disease Control (DC) per RECIST v1.1
Time frame: Up to approximately 3 years
Duration of Response (DOR) per RECIST v1.1
Time frame: Up to approximately 3 years
Time to Response (TTR) per RECIST v1.1
Time frame: Up to approximately 3 years
Overall Survival (OS) per RECIST v1.1
Time frame: Up to approximately 3 years
Progression-free Survival (PFS) per RECIST v1.1
Time frame: Up to approximately 3 years
Maximum Plasma Concentration (Cmax) of AMG 193
Time frame: Up to Day 1 of Cycle 5 (one cycle = 21 days)
Time to Maximum Plasma Concentration (tmax) of AMG 193
Time frame: Up to Day 1 of Cycle 5 (one cycle = 21 days)
Area Under the Plasma Concentration-time Curve (AUC) of AMG 193
Time frame: Up to Day 1 of Cycle 5 (one cycle = 21 days)
Intracranial objective response (IOR) per Response Assessment in Neuro Oncology Brain Metastases (RANO-BM )
Time frame: Up to approximately 3 years
Intracranial Disease Control (IDC) per RANO-BM
Time frame: Up to approximately 3 years
Intracranial Duration of Response (IDOR) per RANO-BM
Time frame: Up to approximately 3 years
Time to Intracranial Radiation Therapy per RANO-BM
Time frame: Up to approximately 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of California Irvine
Orange, California, United States
RECRUITINGUniversity of California Los Angeles
Santa Monica, California, United States
RECRUITINGRocky Mountain Cancer Centers
Denver, Colorado, United States
RECRUITINGEastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States
RECRUITINGHealthPartners Institute
Saint Paul, Minnesota, United States
RECRUITINGSaint Lukes Hospital of Kansas City
Kansas City, Missouri, United States
RECRUITING...and 73 more locations