Lung Cancer Clinical Trial
AMG 193, Methylthioadenosine (MTA) Cooperative Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor, Alone and in Combination With Docetaxel in Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors
Summary
The primary objective of Parts 1 and 2 of this study is to evaluate the safety, tolerability, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of AMG 193 alone and in combination with docetaxel in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-null solid tumors.
The primary objective of Part 3 of this study is to evaluate the objective response rate (ORR) of AMG 193 in adult participants with metastatic or locally advanced MTAP-null non-small cell lung cancer (NSCLC), after prior treatment with chemotherapy and/or a programmed death-1/ligand 1 (PD-1/L1) inhibitor.
Eligibility Criteria
Inclusion Criteria:
Participant has provided informed consent/assent before initiation of any study specific activities/procedures.
Age ≥ 18 years.
Evidence of homozygous loss of cyclin dependent kinase inhibitor 2A (CDKN2A) (null) and/or methylthioadenosine phosphorylase (MTAP) (null) or lost MTAP expression in the tumor tissue.
Histologically confirmed metastatic or locally advanced solid tumor not amenable to curative treatment with surgery and/or radiation.
Able to swallow and retain orally (PO) administered study treatment and willing to record daily adherence to investigational product.
Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Adequate hematopoietic function per local laboratory.
Adequate renal function per local laboratory.
Adequate glucose control per local laboratory (Part 1 only).
Adequate liver function per local laboratory.
Adequate coagulation parameters.
Adequate pulmonary function.
Adequate cardiac function.
Minimum life expectancy of 12 weeks as per investigator judgement.
Tumor tissue must be available.
Exclusion Criteria:
Spinal cord compression or active brain metastases or leptomeningeal disease from non-brain tumors.
Presence of primary brain cancer.
Presence of hematological malignancy or lymphoma.
History of other malignancy within the past 2 years.
Evidence of lung disease.
Active infection.
History of arterial thrombosis.
Myocardial infarction and/or symptomatic congestive heart failure, unstable angina, or cardiac arrhythmia.
Gastrointestinal tract disease.
History of solid organ transplant.
Diagnosis of Congenital Short QT Syndrome.
Prior treatment with an methionine adenosyltransferase 2α (MAT2A) inhibitor or a protein arginine methyltransferase 5 (PRMT5) inhibitor.
Prior irradiation to greater than 25% of the bone marrow.
Unresolved toxicity from prior anti-cancer therapy.
Currently receiving treatment in another investigational device or drug study.
Known positive test for Human Immunodeficiency Virus.
Evidence of hepatitis B or C infection.
Female participants of childbearing potential with a positive pregnancy test.
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There are 25 Locations for this study
Duarte California, 91010, United States
Indianapolis Indiana, 46250, United States
Bethesda Maryland, 20817, United States
Saint Louis Missouri, 63110, United States
Durham North Carolina, 27710, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
Camperdown New South Wales, 2050, Australia
Salzburg , 5020, Austria
Bruxelles , 1200, Belgium
Edegem , 2650, Belgium
Gent , 9000, Belgium
Dijon cedex , 21079, France
Lille , 59000, France
Villejuif , 94805, France
Halle (Saale) , 06120, Germany
Heidelberg , 69120, Germany
Ulm , 89081, Germany
Würzburg , 97078, Germany
Nagoya-shi Aichi, 464-8, Japan
Kashiwa-shi Chiba, 277-8, Japan
Chuo-ku Tokyo, 104-0, Japan
Bellinzona , 6500, Switzerland
Bern , 3010, Switzerland
Geneve 14 , 1211, Switzerland
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