Trial Title:
AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol)
NCT ID:
NCT06333951
Condition:
Thoracic Tumors
Non-small Cell Lung Cancer
Conditions: Official terms:
Thoracic Neoplasms
Paclitaxel
Carboplatin
Pembrolizumab
Pemetrexed
Sotorasib
Conditions: Keywords:
Oncology
Methylthioadenosine phosphorylase
AMG 193
PRMT5 inhibitor
MTAP
NSCLC
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 PO
Arm group label:
Subprotocol A: NSCLC Arm B
Arm group label:
Subprotocol A: NSCLC Arm C
Arm group label:
Subprotocol A: Non-Small Cell Lung Cancer (NSCLC) Arm A
Arm group label:
Subprotocol B: NSCLC With KRasG12C Mutation
Arm group label:
Subprotocol C: NSCLC With Brain Metastases
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Administered IV
Arm group label:
Subprotocol A: NSCLC Arm B
Arm group label:
Subprotocol A: Non-Small Cell Lung Cancer (NSCLC) Arm A
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Administered IV
Arm group label:
Subprotocol A: Non-Small Cell Lung Cancer (NSCLC) Arm A
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Administered IV
Arm group label:
Subprotocol A: NSCLC Arm B
Arm group label:
Subprotocol A: NSCLC Arm C
Arm group label:
Subprotocol A: Non-Small Cell Lung Cancer (NSCLC) Arm A
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
Administered IV
Arm group label:
Subprotocol A: NSCLC Arm B
Intervention type:
Drug
Intervention name:
Sotorasib
Description:
Administered PO
Arm group label:
Subprotocol B: NSCLC With KRasG12C Mutation
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria
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.
Exclusion Criteria
Subprotocol A, B, and C
- 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 transplant.
- Major surgery within 28 days of first dose of AMG 193.
- Prior treatment with a MAT2A inhibitor or a PRMT5 inhibitor.
- Radiation therapy within 28 days of first dose.
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:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Facility:
Name:
Eastern Connecticut Hematology and Oncology Associates
Address:
City:
Norwich
Zip:
06360
Country:
United States
Status:
Recruiting
Facility:
Name:
HealthPartners Institute
Address:
City:
Saint Paul
Zip:
55102
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:
New York University Grossman School of Medicine
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Facility:
Name:
Perlmutter Cancer Center at New York University Langone Hospital----Long Island
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Facility:
Name:
Hightower Clinical
Address:
City:
Oklahoma City
Zip:
73102
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Tennessee Medical Center Knoxville
Address:
City:
Knoxville
Zip:
37920
Country:
United States
Status:
Recruiting
Facility:
Name:
Baylor Charles A Sammons Cancer Center
Address:
City:
Dallas
Zip:
75246
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology - Dallas Fort Worth
Address:
City:
Dallas
Zip:
75246
Country:
United States
Status:
Recruiting
Facility:
Name:
US Oncology Research Investigational Products Center
Address:
City:
Dallas
Zip:
75246
Country:
United States
Status:
Recruiting
Facility:
Name:
Oncology Consultants Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology Northeast Texas
Address:
City:
Tyler
Zip:
75702
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:
Orange Health Service
Address:
City:
Orange
Zip:
2800
Country:
Australia
Status:
Recruiting
Facility:
Name:
The Queen Elizabeth Hospital
Address:
City:
Woodville South
Zip:
5011
Country:
Australia
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa-shi
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Facility:
Name:
Shizuoka Cancer Center
Address:
City:
Sunto-gun
Zip:
411-8777
Country:
Japan
Status:
Recruiting
Facility:
Name:
Wakayama Medical University Hospital
Address:
City:
Wakayama-shi
Zip:
641-8510
Country:
Japan
Status:
Recruiting
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
National Cheng Kung University Hospital
Address:
City:
Tainan
Zip:
70403
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Taipei Veterans General Hospital
Address:
City:
Taipei
Zip:
11217
Country:
Taiwan
Status:
Recruiting
Start date:
September 17, 2024
Completion date:
June 16, 2032
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/NCT06333951
http://www.amgentrials.com
