A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol)

Status: Recruiting
Location: See all (80) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

⁃ Subprotocol A, B, and C

• Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).

• Tumor tissue (formalin-fixed, paraffin-embedded sample) or an archival block must be available. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before AMG 193 dosing.

• Homozygous MTAP-deletion

• Able to swallow and retain PO administered study treatment.

• Disease measurable as defined by RECIST v1.1.

⁃ Subprotocol A - Histologically or cytologically confirmed diagnosis of NSCLC.

⁃ Arm A (AMG 193 + carboplatin + paclitaxel + pembrolizumab):

⁃ \- Predominantly squamous histology.

⁃ Arm B (AMG 193 + carboplatin + pemetrexed + pembrolizumab):

⁃ \- Predominantly non-squamous histology.

⁃ Arm C (AMG 193 + pembrolizumab):

⁃ \- PD-L1 positive.

⁃ Subprotocol B - Histologically confirmed NSCLC with homozygous MTAP-deletion and KRAS p.G12C mutation.

⁃ Subprotocol C

• Histologically or cytologically confirmed diagnosis of NSCLC with brain metastases.

• Brain lesion meeting RANO-BM criteria for measurable disease.

Locations
United States
California
Comprehensive Blood and Cancer Center
RECRUITING
Bakersfield
City of Hope National Medical Center
RECRUITING
Duarte
City of Hope Orange County Lennar Foundation Cancer Center
RECRUITING
Duarte
Translational Research in Oncology US Inc, Trio Central Pharmacy
RECRUITING
Los Angeles
University of California Irvine
RECRUITING
Orange
University of California Los Angeles
RECRUITING
Santa Monica
Colorado
Rocky Mountain Cancer Centers
RECRUITING
Denver
Connecticut
Eastern Connecticut Hematology and Oncology Associates
RECRUITING
Norwich
Minnesota
HealthPartners Institute
RECRUITING
Saint Paul
Missouri
Saint Lukes Hospital of Kansas City
RECRUITING
Kansas City
Nevada
Comprehensive Cancer Centers of Nevada
TERMINATED
Las Vegas
New York
Roswell Park Cancer Institute
RECRUITING
Buffalo
New York University Grossman School of Medicine
RECRUITING
New York
Perlmutter Cancer Center at New York University Langone Hospital----Long Island
RECRUITING
New York
Upstate University Hospital
RECRUITING
Syracuse
Oklahoma
Hightower Clinical
RECRUITING
Oklahoma City
Pennsylvania
Fox Chase Cancer Center
RECRUITING
Philadelphia
Tennessee
University of Tennessee Medical Center Knoxville
RECRUITING
Knoxville
United States Oncology Regulatory Affairs Corporate Office
RECRUITING
Nashville
Texas
Texas Oncology - Dallas Fort Worth
RECRUITING
Dallas
US Oncology Research Investigational Products Center
RECRUITING
Dallas
Oncology Consultants Cancer Center
TERMINATED
Houston
Texas Oncology Northeast Texas
RECRUITING
Tyler
Virginia
Virginia Cancer Specialists PC
RECRUITING
Fairfax
Washington
Northwest Medical Specialties, PLLC
RECRUITING
Tacoma
Other Locations
Argentina
Instituto Argentino de Diagnóstico y Tratamiento
RECRUITING
Ciudad Automona De Buenos Aires
Cemic
RECRUITING
Ciudad Autonoma Buenos Aires
Australia
Orange Health Service
RECRUITING
Orange
The Queen Elizabeth Hospital
RECRUITING
Woodville South
Austria
Medizinische Universitaet Graz
RECRUITING
Graz
Medizinische Universitaet Innsbruck
RECRUITING
Innsbruck
Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
RECRUITING
Liège
Brazil
Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda
RECRUITING
Ijuí
Fund Fac Reg Med Sao Jose Rio Preto
RECRUITING
São José Do Rio Preto
Beneficencia Portuguesa de Sao Paulo - Bp
RECRUITING
São Paulo
Instituto Cancer Sao Paulo Icesp
RECRUITING
São Paulo
Canada
Princess Margaret Cancer Centre
RECRUITING
Toronto
China
Beijing Cancer Hospital
RECRUITING
Beijing
Jilin Cancer Hospital
RECRUITING
Changchun
West China Hospital of Sichuan University
RECRUITING
Chengdu
Mengchao Hepatobiliary hospital of Fujian Medical University
RECRUITING
Fuzhou
Guangdong Provincial Peoples Hospital
RECRUITING
Guangzhou
Union Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITING
Wuhan
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
France
Institut Bergonie
RECRUITING
Bordeaux
Hopital de la Timone
RECRUITING
Marseille
Institut de Cancerologie de l Ouest Rene Gauducheau
RECRUITING
Saint-herblain
Gustave Roussy
RECRUITING
Villejuif
Germany
Universitaetsklinikum Essen
RECRUITING
Essen
Thoraxklinik Heidelberg
RECRUITING
Heidelberg
Universitaetsklinikum Wuerzburg
RECRUITING
Würzburg
Greece
Alexandra Hospital
RECRUITING
Athens
General Hospital Of Thessaloniki Papageorgiou
RECRUITING
Thessaloniki
Saint Luke Hospital
RECRUITING
Thessaloniki
Hong Kong Special Administrative Region
Queen Mary Hospital, The University of Hong Kong
RECRUITING
Hong Kong
Prince of Wales Hospital, Chinese University of Hong Kong
RECRUITING
Shatin, New Territories
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING
Alessandria
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
IRCCS Istituto Clinico Humanitas
RECRUITING
Rozzano (mi)
Centro Ricerche Cliniche Di Verona Societa responsabilita limitata
RECRUITING
Verona
Japan
National Cancer Center Hospital East
RECRUITING
Kashiwa-shi
Aichi Cancer Center
RECRUITING
Nagoya
Shizuoka Cancer Center
RECRUITING
Sunto-gun
Wakayama Medical University Hospital
RECRUITING
Wakayama
Netherlands
Radboud Universitair Medisch Centrum
RECRUITING
Nijmegen
Poland
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gdansk
Narodowy Instytut Onkologii im Marii Slodowskiej-Curie Panstwowy Instytut Badawczy
RECRUITING
Gliwice
Futuremeds spolka z ograniczona odpowiedzialnoscia
RECRUITING
Krakow
Instytut Centrum Zdrowia Matki Polki
RECRUITING
Lodz
Centrum Medyczne Hope Clinic Sebastian Szklener
RECRUITING
Lublin
Republic of Korea
Asan Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Spain
Hospital Clinic i Provincial de Barcelona
RECRUITING
Barcelona
Hospital Universitari Vall d Hebron
RECRUITING
Barcelona
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Taiwan
National Cheng Kung University Hospital
RECRUITING
Tainan City
Taipei Veterans General Hospital
RECRUITING
Taipei
Turkey
Adana Sehir Egitim ve Arastirma Hastanesi
RECRUITING
Adana
Ankara Bilkent Sehir Hastanesi
RECRUITING
Ankara
Hacettepe Universitesi Tip Fakultesi Hastanesi
RECRUITING
Ankara
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date: 2024-09-17
Estimated Completion Date: 2031-10-27
Participants
Target number of participants: 500
Treatments
Experimental: Subprotocol A: Non-Small Cell Lung Cancer (NSCLC) Arm A
Participants with MTAP-deleted NSCLC will receive a regimen of AMG 193 orally (PO) and carboplatin, paclitaxel, and pembrolizumab intravenously (IV)
Experimental: Subprotocol A: NSCLC Arm B
Participants with MTAP-deleted NSCLC will receive a regimen of AMG 193 PO and carboplatin, pemetrexed, and pembrolizumab IV
Experimental: Subprotocol A: NSCLC Arm C
Participants with MTAP-deleted NSCLC will receive a combination of AMG 193 PO and pembrolizumab IV
Experimental: Subprotocol B: NSCLC With KRasG12C Mutation
Participants with MTAP-deleted NSCLC and KRasG12C mutation will receive a combination of AMG 193 and sotorasib PO
Experimental: Subprotocol C: NSCLC With Brain Metastases
Participants with MTAP-deleted NSCLC with brain metastases will receive AMG 193 PO
Sponsors
Leads: Amgen

This content was sourced from clinicaltrials.gov