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.

View Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

340

Study ID:

NCT05094336

Recruitment Status:

Recruiting

Sponsor:

Amgen

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There are 25 Locations for this study

See Locations Near You

City of Hope National Medical Center
Duarte California, 91010, United States
Community Health Network
Indianapolis Indiana, 46250, United States
American Oncology Partners of Maryland, PA
Bethesda Maryland, 20817, United States
Washington University
Saint Louis Missouri, 63110, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
South Texas Accelerated Research Therapeutics
San Antonio Texas, 78229, United States
Chris OBrien Lifehouse
Camperdown New South Wales, 2050, Australia
Landeskrankenhaus Salzburg
Salzburg , 5020, Austria
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Bruxelles , 1200, Belgium
Universitair Ziekenhuis Antwerpen
Edegem , 2650, Belgium
Universitair Ziekenhuis Gent
Gent , 9000, Belgium
Centre Georges François Leclerc
Dijon cedex , 21079, France
Centre Oscar Lambret
Lille , 59000, France
Institut Gustave Roussy
Villejuif , 94805, France
Universitaetsklinikum Halle - Saale
Halle (Saale) , 06120, Germany
Nationales Centrum für Tumorerkrankungen Heidelberg
Heidelberg , 69120, Germany
Universitaetsklinikum Ulm
Ulm , 89081, Germany
Universitaetsklinikum Wuerzburg
Würzburg , 97078, Germany
Aichi Cancer Center
Nagoya-shi Aichi, 464-8, Japan
National Cancer Center Hospital East
Kashiwa-shi Chiba, 277-8, Japan
National Cancer Center Hospital
Chuo-ku Tokyo, 104-0, Japan
Istituto Oncologico della Svizzera Italiana
Bellinzona , 6500, Switzerland
Inselspital Bern
Bern , 3010, Switzerland
Hopitaux Universitaires de Geneve
Geneve 14 , 1211, Switzerland

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

340

Study ID:

NCT05094336

Recruitment Status:

Recruiting

Sponsor:


Amgen

How clear is this clinincal trial information?

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