Trial Title:
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
NCT ID:
NCT06360354
Condition:
Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers
Conditions: Official terms:
Pancreatic Neoplasms
Paclitaxel
Gemcitabine
Folfirinox
Conditions: Keywords:
Advanced Cancer
Methylthioadenosine Phosphorylase
AMG 193
Oncology
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AMG 193
Description:
Administered Orally
Arm group label:
Subprotocol B: PDAC Arm B
Arm group label:
Subprotocol B: Pancreatic Ductal Adenocarcinoma (PDAC) Arm A
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Administered IV
Arm group label:
Subprotocol B: Pancreatic Ductal Adenocarcinoma (PDAC) Arm A
Intervention type:
Drug
Intervention name:
Nab-paclitaxel
Description:
Administered IV
Arm group label:
Subprotocol B: Pancreatic Ductal Adenocarcinoma (PDAC) Arm A
Intervention type:
Drug
Intervention name:
Modified FOLFIRINOX
Description:
Modified FOLFIRINOX consists of irinotecan, 5-FU, LV, and oxaliplatin administered IV
Arm group label:
Subprotocol B: PDAC Arm B
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.
Criteria for eligibility:
Criteria:
Subprotocol B
Inclusion:
- 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.
Exclusion:
- Prior treatment with a MAT2A inhibitor or a PRMT5 inhibitor.
- Radiation therapy within 28 days of first dose.
- Major surgery within 28 days of first dose of AMG 193.
- Cardiovascular and pulmonary exclusion criteria as defined in the protocol.
- Gastrointestinal tract disease causing the inability to take PO medication,
malabsorption syndrome, requirement for IV alimentation, gastric/jejunal tube feeds,
uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative
colitis).
- History of solid organ transplantation.
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Comprehensive Blood and Cancer Center
Address:
City:
Bakersfield
Zip:
93309
Country:
United States
Status:
Recruiting
Facility:
Name:
City of Hope National Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Facility:
Name:
Translational Research in Oncology US Inc, Trio Central Pharmacy
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Facility:
Name:
University of California Los Angeles
Address:
City:
Santa Monica
Zip:
90404
Country:
United States
Status:
Recruiting
Facility:
Name:
Rocky Mountain Cancer Centers
Address:
City:
Aurora
Zip:
80012
Country:
United States
Status:
Recruiting
Facility:
Name:
Hartford Hospital
Address:
City:
Hartford
Zip:
06105
Country:
United States
Status:
Recruiting
Facility:
Name:
Norwalk Hospital
Address:
City:
Norwalk
Zip:
06856
Country:
United States
Status:
Recruiting
Facility:
Name:
Indiana University
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Status:
Recruiting
Facility:
Name:
Norton Cancer Institute
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington University
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Comprehensive Cancer Centers of Nevada
Address:
City:
Las Vegas
Zip:
89169
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Facility:
Name:
Cleveland Clinic Foundation
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Facility:
Name:
Oncology Consultants Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
US Oncology Research Investigational Products Center
Address:
City:
Irving
Zip:
75063
Country:
United States
Status:
Recruiting
Facility:
Name:
Virginia Cancer Specialists PC
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwest Medical Specialties, PLLC
Address:
City:
Tacoma
Zip:
98405
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwest Cancer Specialists - Vancouver
Address:
City:
Vancouver
Zip:
98684
Country:
United States
Status:
Recruiting
Facility:
Name:
Chris OBrien Lifehouse
Address:
City:
Camperdown
Zip:
2050
Country:
Australia
Status:
Recruiting
Facility:
Name:
GenesisCare -North Shore Oncology
Address:
City:
St Leonards
Zip:
2065
Country:
Australia
Status:
Recruiting
Facility:
Name:
The Queen Elizabeth Hospital
Address:
City:
Woodville South
Zip:
5011
Country:
Australia
Status:
Recruiting
Facility:
Name:
Austin Health, Austin Hospital
Address:
City:
Heidelberg
Zip:
3084
Country:
Australia
Status:
Recruiting
Facility:
Name:
Peter MacCallum Cancer Centre
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Status:
Recruiting
Facility:
Name:
Epworth Healthcare
Address:
City:
St Albans
Zip:
3021
Country:
Australia
Status:
Recruiting
Facility:
Name:
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Address:
City:
Bruxelles
Zip:
1200
Country:
Belgium
Status:
Recruiting
Facility:
Name:
CHU de Quebec Hopital de l Enfant Jesus
Address:
City:
Quebec
Zip:
G1J 1Z4
Country:
Canada
Status:
Recruiting
Facility:
Name:
Herlev og Gentofte Hospital
Address:
City:
Herlev
Zip:
2730
Country:
Denmark
Status:
Recruiting
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Essen
Address:
City:
Essen
Zip:
45147
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Heidelberg
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Wuerzburg
Address:
City:
Wuerzburg
Zip:
97078
Country:
Germany
Status:
Recruiting
Facility:
Name:
Saint Luke Hospital
Address:
City:
Thessaloniki
Zip:
55236
Country:
Greece
Status:
Recruiting
Facility:
Name:
General Hospital Of Thessaloniki Papageorgiou
Address:
City:
Thessaloniki
Zip:
56429
Country:
Greece
Status:
Recruiting
Facility:
Name:
Centro Ricerche Cliniche Di Verona Societa responsabilita limitata
Address:
City:
Verona
Zip:
37134
Country:
Italy
Status:
Recruiting
Facility:
Name:
Aichi Cancer Center
Address:
City:
Nagoya-shi
Zip:
464-8681
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa-shi
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Address:
City:
Yokohama-shi
Zip:
241-8515
Country:
Japan
Status:
Recruiting
Facility:
Name:
Radboud Universitair Medisch Centrum
Address:
City:
Nijmegen
Zip:
6525 GA
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen del Rocio
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitari Vall d Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
National Cheng Kung University Hospital
Address:
City:
Tainan
Zip:
70403
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
10002
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Taipei Veterans General Hospital
Address:
City:
Taipei
Zip:
11217
Country:
Taiwan
Status:
Recruiting
Start date:
May 29, 2024
Completion date:
April 30, 2028
Lead sponsor:
Agency:
Amgen
Agency class:
Industry
Source:
Amgen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06360354
http://www.amgentrials.com
