Trial Title:
A Phase 1/2 Study of AMG 193 in Combination With IDE397 in Participants With Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors
NCT ID:
NCT05975073
Condition:
MTAP-null Non-Small-Cell Lung Cancer
MTAP-null Solid Tumors
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Oncology
AMG 193
IDE397
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AMG 193
Description:
Administered PO
Arm group label:
Part 1: Dose Exploration of AMG 193 Combined With IDE397
Arm group label:
Part 2: Dose Expansion of AMG 193 Combined With IDE397
Intervention type:
Drug
Intervention name:
IDE397
Description:
Administered PO
Arm group label:
Part 1: Dose Exploration of AMG 193 Combined With IDE397
Arm group label:
Part 2: Dose Expansion of AMG 193 Combined With IDE397
Summary:
The main aims of this study are to evaluate the safety and tolerability, and to determine
the maximum tolerated dose (MTD) or the recommended combination dose of AMG 193 in
combination with IDE397 in adult participants with metastatic or locally advanced
MTAP-null solid tumors, and to evaluate the preliminary anti-tumor activity of AMG 193 in
combination with IDE397 in adult participants with metastatic or locally advanced
MTAP-null Non-Small-Cell Lung Cancer (NSCLC).
Criteria for eligibility:
Criteria:
Inclusion Criteria
1. Evidence of homozygous loss of MTAP (null) and/or MTAP deletion.
2. Presence of advanced/metastatic solid tumor not amenable to curative treatment
1. Part 1: MTAP-null or lost MTAP expression solid tumor for which no standard
therapy exists
2. Part 2: MTAP-null or lost MTAP expression NSCLC with progression after 1 to 2
prior lines of systemic therapy.
3. Able to swallow and retain PO administered study treatment and willing to record
adherence to investigational product
4. Disease measurable as defined by RECIST v1.1
5. Adequate organ function as defined in the protocol.
6. Archived tumor tissue. Participants without archived tumor tissue available may be
allowed to enroll by undergoing tumor biopsy before cycle 1 day 1 dosing.
Exclusion Criteria
1. Prior treatment with an MAT2A inhibitor or a PRMT5 inhibitor.
2. Radiologic or clinical evidence of spinal cord compression, untreated or symptomatic
brain metastases or leptomeningeal disease.
3. Cardiovascular and pulmonary exclusion criteria as defined in the protocol.
4. 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)
5. History of bowel obstruction, abdominal fistula, gastrointestinal perforation, or
intra-abdominal abscess within 6 months of study entry.
6. Prior irradiation to > 25% of the bone marrow
7. Use of prescription medications that are known strong CYP3A4/5 inducers or strong
CYP3A4/5 inhibitors within 7 days for CYP3A4/5 inhibitors, 14 days for CYP3A4/5
inducers or 5 half-lives, whichever is longer, prior to any dose of investigational
medical product.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope National Medical Center
Address:
City:
Duarte
Zip:
91090
Country:
United States
Status:
Recruiting
Facility:
Name:
Sarah Cannon Research Institute
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Facility:
Name:
Community Health Network MD Anderson Cancer Center - North
Address:
City:
Indianapolis
Zip:
46250
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Michigan
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Facility:
Name:
Health Partners Cancer Center at Regions Hospital
Address:
City:
Saint Paul
Zip:
55102
Country:
United States
Status:
Recruiting
Facility:
Name:
Astera Cancer Care
Address:
City:
East Brunswick
Zip:
08816
Country:
United States
Status:
Recruiting
Facility:
Name:
New York University Grossman School of Medicine and New York University Langone Hospitals
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Facility:
Name:
Columbia University Irving Medical Center
Address:
City:
New York
Zip:
10032
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:
Duke University
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Facility:
Name:
Prisma Health Upstate
Address:
City:
Greenville
Zip:
29605
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Next Oncology
Address:
City:
Irving
Zip:
75039
Country:
United States
Status:
Recruiting
Facility:
Name:
The Queen Elizabeth Hospital
Address:
City:
Woodville South
Zip:
5011
Country:
Australia
Status:
Recruiting
Facility:
Name:
Monash Medical Centre
Address:
City:
Clayton
Zip:
3168
Country:
Australia
Status:
Recruiting
Facility:
Name:
Cross Cancer Institute
Address:
City:
Edmonton
Zip:
T6G 1Z2
Country:
Canada
Status:
Recruiting
Facility:
Name:
Princess Margaret Cancer Centre
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Facility:
Name:
Rigshospitalet
Address:
City:
Copenhagen
Zip:
2100
Country:
Denmark
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Severance Hospital Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Hospital Universitari Vall d Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Ramon y Cajal
Address:
City:
Madrid
Zip:
28034
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
Start date:
August 1, 2023
Completion date:
September 8, 2027
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/NCT05975073
http://www.amgentrials.com
