A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 193 in Combination With Other Therapies in Subjects With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous MTAP-deletion

Status: Recruiting
Location: See all (77) 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 gastrointestinal, biliary tract, or pancreatic cancers. 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 gastrointestinal, biliary tract, or pancreatic cancers.

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

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

• Histologically or cytologically confirmed diagnosis of metastatic and/or unresectable (locally advanced) adenocarcinoma of the pancreas.

• Tumor tissue (FFPE sample) or an archival block must be available. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before dosing.

• Homozygous MTAP-deletion.

• Disease measurable as defined by RECIST v1.1.

• Adequate organ function as defined in the protocol.

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

• Histologically or cytologically confirmed diagnosis of metastatic and/or unresectable (locally advanced) adenocarcinoma of the pancreas.

• Homozygous MTAP-deletion.

• Rat Sarcoma Viral Oncogene Homolog (RAS) mutation

• Received at least 1 prior systemic therapy for advanced or metastatic PDAC.

• Disease measurable as defined by RECIST v1.1.

• Adequate organ function as defined in the protocol.

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
University of California San Diego Moores Cancer Center
RECRUITING
La Jolla
Translational Research in Oncology US Inc, Trio Central Pharmacy
RECRUITING
Los Angeles
University of California Los Angeles
RECRUITING
Santa Monica
Colorado
Rocky Mountain Cancer Centers
RECRUITING
Aurora
Connecticut
Hartford Hospital
RECRUITING
Hartford
Yale University
RECRUITING
New Haven
Norwalk Hospital
RECRUITING
Norwalk
Illinois
University of Chicago
RECRUITING
Chicago
Indiana
Indiana University
RECRUITING
Indianapolis
Kentucky
Norton Cancer Institute
RECRUITING
Louisville
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Dana-Farber Cancer Institute
RECRUITING
Boston
Missouri
Washington University
RECRUITING
St Louis
North Carolina
Duke University
RECRUITING
Durham
Nebraska
University of Nebraska
RECRUITING
Omaha
Nevada
Comprehensive Cancer Centers of Nevada
TERMINATED
Las Vegas
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Ohio
Cleveland Clinic Foundation
RECRUITING
Cleveland
Tennessee
United States Oncology Regulatory Affairs Corporate Office
RECRUITING
Nashville
Texas
Oncology Consultants Cancer Center
TERMINATED
Houston
US Oncology Research Investigational Products Center
RECRUITING
Irving
Virginia
University of Virginia Cancer Center
RECRUITING
Charlottesville
Virginia Cancer Specialists PC
RECRUITING
Fairfax
Washington
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Northwest Medical Specialties, PLLC
RECRUITING
Tacoma
Northwest Cancer Specialists - Vancouver
RECRUITING
Vancouver
Other Locations
Australia
Chris OBrien Lifehouse
RECRUITING
Camperdown
Austin Health, Austin Hospital
RECRUITING
Heidelberg
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
Epworth Healthcare
RECRUITING
St Albans
GenesisCare -North Shore Oncology
RECRUITING
St Leonards
The Queen Elizabeth Hospital
RECRUITING
Woodville South
Belgium
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
RECRUITING
Brussels
Universitair Ziekenhuis Antwerpen
RECRUITING
Edegem
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
RECRUITING
Leuven
Canada
Arthur J E Child Comprehensive Cancer Centre
RECRUITING
Calgary
CHU de Quebec Hopital de l Enfant Jesus
RECRUITING
Québec
Princess Margaret Cancer Centre
RECRUITING
Toronto
China
The First Bethune Hospital of Jilin University
RECRUITING
Changchun
Mengchao Hepatobiliary hospital of Fujian Medical University
RECRUITING
Fuzhou
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Harbin Medical University Cancer Hospital
RECRUITING
Harbin
Union Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITING
Wuhan
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Denmark
Herlev og Gentofte Hospital
RECRUITING
Herlev
France
Institut Bergonie
RECRUITING
Bordeaux
Centre Georges Francois Leclerc
RECRUITING
Dijon
Institut Paoli Calmettes
RECRUITING
Marseille
Gustave Roussy
RECRUITING
Villejuif
Germany
Universitaetsklinikum Essen
RECRUITING
Essen
Universitaetsklinikum 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
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING
Milan
IRCCS Istituto Clinico Humanitas
RECRUITING
Rozzano Mi
Centro Ricerche Cliniche Di Verona Societa responsabilita limitata
RECRUITING
Verona
Japan
National Cancer Center Hospital
RECRUITING
Chuo-ku
National Cancer Center Hospital East
RECRUITING
Kashiwa-shi
Aichi Cancer Center
RECRUITING
Nagoya
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
RECRUITING
Yokohama
Netherlands
Radboud Universitair Medisch Centrum
RECRUITING
Nijmegen
Spain
Hospital Universitari Vall d Hebron
RECRUITING
Barcelona
Hospital General Universitario Gregorio Maranon
RECRUITING
Madrid
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Taiwan
National Cheng Kung University Hospital
RECRUITING
Tainan
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
United Kingdom
Queen Elizabeth Hospital Birmingham
RECRUITING
Birmingham
Sarah Cannon Research Institute UK
RECRUITING
London
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date: 2024-05-29
Estimated Completion Date: 2029-02-25
Participants
Target number of participants: 350
Treatments
Experimental: Subprotocol B: Pancreatic Ductal Adenocarcinoma (PDAC) Arm A
Part 1: Participants with MTAP-deleted PDAC will receive doses of AMG 193 orally in combination with gemcitabine and nab-paclitaxel IV.~Part 2: Participants with MTAP-deleted PDAC will receive the recommended dose of AMG 193 in combination with gemcitabine and nab-paclitaxel.
Experimental: Subprotocol B: PDAC Arm B
Part 1: Participants with MTAP-deleted PDAC will receive doses of AMG 193 orally in combination with mFOLFIRINOX (irinotecan, fluorouracil, leucovorin calcium, oxaliplatin) IV.~Part 2: Participants with MTAP-deleted PDAC will receive the recommended dose of AMG 193 in combination with mFOLFIRINOX.
Experimental: Subprotocol C: Dose Exploration
Part 1: Participants with MTAP-deleted PDAC will receive oral doses of AMG 193 and RMC-6236.
Experimental: Subprotocol C: Dose Expansion
Part 2: Participants with MTAP-deleted PDAC will receive oral doses of AMG 193 andRMC-6236.
Related Therapeutic Areas
Pancreatic Cancer
Sponsors
Leads: Amgen

This content was sourced from clinicaltrials.gov

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