A Study Evaluating AMG 193 in Combination With Other Therapies in Participants With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous Methylthioadenosine Phosphorylase (MTAP)-Deletion
- Conditions
- Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers
- Interventions
- Registration Number
- NCT06360354
- Lead Sponsor
- Amgen
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 188
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Subprotocol B: Pancreatic Ductal Adenocarcinoma (PDAC) Arm A AMG 193 Part 1: Participants with MTAP-deleted PDAC will receive escalating 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. Subprotocol B: Pancreatic Ductal Adenocarcinoma (PDAC) Arm A Nab-paclitaxel Part 1: Participants with MTAP-deleted PDAC will receive escalating 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. Subprotocol B: PDAC Arm B AMG 193 Part 1: Participants with MTAP-deleted PDAC will receive escalating 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. Subprotocol B: PDAC Arm B Modified FOLFIRINOX Part 1: Participants with MTAP-deleted PDAC will receive escalating 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. Subprotocol B: Pancreatic Ductal Adenocarcinoma (PDAC) Arm A Gemcitabine Part 1: Participants with MTAP-deleted PDAC will receive escalating 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.
- Primary Outcome Measures
Name Time Method Number of Participants Experiencing Dose Limiting Toxicities (DLT) Up to 28 days Number of Participants Experiencing Serious Adverse Events (SAE) Up to approximately 2 years Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE) Up to approximately 2 years Any clinically significant changes in vital signs, electrocardiogram, or lab parameters will be recorded as TEAEs.
- Secondary Outcome Measures
Name Time Method Time to Response (TTR) per RECIST v1.1 Up to approximately 2 years Time to Maximum Plasma Concentration (tmax) of AMG193 Up to Day 1 of Cycle 5 (one cycle = 21 or 28 days) Disease Control (DC) per RECIST v1.1 Up to approximately 2 years Duration of Response (DOR) per RECIST v1.1 Up to approximately 2 years Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Up to approximately 2 years Overall Survival (OS) per RECIST v1.1 Up to approximately 2 years Progression-free Survival (PFS) per RECIST v1.1 Up to approximately 2 years Maximum Plasma Concentration (Cmax) of AMG193 Up to Day 1 of Cycle 5 (one cycle = 21 or 28 days) Area Under the Plasma Concentration-time Curve (AUC) of AMG 193 Up to Day 1 of Cycle 5 (one cycle = 21 or 28 days)
Trial Locations
- Locations (60)
Prince of Wales Hospital / CUHK
ðŸ‡ðŸ‡°Shatin, New Territories, Hong Kong
Comprehensive Blood and Cancer Center
🇺🇸Bakersfield, California, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
Translational Research in Oncology US Inc, Trio Central Pharmacy
🇺🇸Los Angeles, California, United States
University of California Los Angeles
🇺🇸Santa Monica, California, United States
Rocky Mountain Cancer Centers
🇺🇸Aurora, Colorado, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Norwalk Hospital
🇺🇸Norwalk, Connecticut, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Norton Cancer Institute
🇺🇸Louisville, Kentucky, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Oncology Consultants Cancer Center
🇺🇸Houston, Texas, United States
US Oncology Research Investigational Products Center
🇺🇸Irving, Texas, United States
Virginia Cancer Specialists PC
🇺🇸Fairfax, Virginia, United States
Northwest Medical Specialties, PLLC
🇺🇸Tacoma, Washington, United States
Northwest Cancer Specialists - Vancouver
🇺🇸Vancouver, Washington, United States
Chris OBrien Lifehouse
🇦🇺Camperdown, New South Wales, Australia
GenesisCare -North Shore Oncology
🇦🇺St Leonards, New South Wales, Australia
The Queen Elizabeth Hospital
🇦🇺Woodville South, South Australia, Australia
Austin Health, Austin Hospital
🇦🇺Heidelberg, Victoria, Australia
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia
Epworth Healthcare
🇦🇺St Albans, Victoria, Australia
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
🇧🇪Bruxelles, Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
🇧🇪Leuven, Belgium
CHU de Quebec Hopital de l Enfant Jesus
🇨🇦Quebec, Canada
Herlev og Gentofte Hospital
🇩🇰Herlev, Denmark
Institut Bergonie
🇫🇷Bordeaux, France
Centre Georges Francois Leclerc
🇫🇷Dijon, France
Institut Paoli Calmettes
🇫🇷Marseille, France
Gustave Roussy
🇫🇷Villejuif, France
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Universitaetsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Universitaetsklinikum Wuerzburg
🇩🇪Wuerzburg, Germany
Alexandra Hospital
🇬🇷Athens, Greece
Saint Luke Hospital
🇬🇷Thessaloniki, Greece
General Hospital Of Thessaloniki Papageorgiou
🇬🇷Thessaloniki, Greece
Queen Mary Hospital / HKU
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Fondazione IRCCS Istituto Nazionale dei Tumori
🇮🇹Milano, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
🇮🇹Milano, Italy
IRCCS Istituto Clinico Humanitas
🇮🇹Rozzano MI, Italy
Centro Ricerche Cliniche Di Verona Societa responsabilita limitata
🇮🇹Verona, Italy
Aichi Cancer Center
🇯🇵Nagoya-shi, Aichi, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa-shi, Chiba, Japan
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
🇯🇵Yokohama-shi, Kanagawa, Japan
National Cancer Center Hospital
🇯🇵Chuo-ku, Tokyo, Japan
Radboud Universitair Medisch Centrum
🇳🇱Nijmegen, Netherlands
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, AndalucÃa, Spain
Hospital Universitari Vall d Hebron
🇪🇸Barcelona, Cataluña, Spain
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Sarah Cannon Research Institute UK
🇬🇧London, United Kingdom
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