Trial Title:
A Study of AMG 355 Alone and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
NCT ID:
NCT06131398
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Pembrolizumab
Conditions: Keywords:
Advanced Solid Tumors
AMG 355
Pembrolizumab
Pharmacokinetics
Non-small Cell Lung Cancer (NSCLC)
Colorectal Cancer (CRC)
Gastric Cancer (GC)
Melanoma (MEL)
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AMG 355
Description:
Short-term intravenous (IV) infusion
Arm group label:
Group A: AMG 355 monotherapy
Arm group label:
Group B: AMG 355 and pembrolizumab
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Short-term IV infusion
Arm group label:
Group B: AMG 355 and pembrolizumab
Other name:
Keytruda
Summary:
The primary objectives of this study are to:
- Evaluate the safety and tolerability of AMG 355 as monotherapy and in combination
with pembrolizumab in participants with advanced solid tumors
- Determine the recommended phase 2 dose and the maximum tolerated dose for AMG 355 as
monotherapy and in combination with pembrolizumab in participants with advanced
solid tumors.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- Age ≥ 18 years at the time of signing informed consent.
- Participants with histologically or cytologically confirmed metastatic or locally
advanced solid tumors who have relapsed after and/or are refractory to or ineligible
for established and available therapies with known clinical benefit at time of
pre-screening:
- Group A: NSCLC, CRC, GC, and melanoma. Additional indications may be explored
in consultation with Medical Monitor.
- Group B: NSCLC, CRC, GC. Additional indications may be explored in consultation
with Medical Monitor.
- Eastern Cooperative Oncology Group Performance status 0 or 1.
- Life expectancy of > 3 months, in the opinion of the investigator.
- At least 1 measurable lesion as defined by modified RECIST 1.1 guidelines. Note:
this lesion must not be used for the required biopsies on the study.
- Participants must be willing to undergo 1 or more biopsies as follows:
- Fresh biopsy prior to enrollment is preferred or, if fresh tissue is not
obtainable, an archival tumor sample may be acceptable if the sample was
obtained within 6 months of enrollment and participant has not received any
other treatment since sample was obtained, consult the Medical Monitor.
- Mandatory fresh biopsy during cycle 2 (before the restaging of CT-scan) of
treatment with AMG 355 (± pembrolizumab).
Note: Samples must consist of a minimum of 10 (20 preferred) freshly-cut, serially,
sectioned, unstained slides. A formalin-fixed, paraffin embedded block is preferred if
available, but in lieu of a block, unstained slides or fresh wet tissue is acceptable.
Key Exclusion Criteria:
- Participant who received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2
agent or with an agent directed to another stimulatory or co-inhibitory T-cell
receptor (eg, cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40, CD137),
and was discontinued from that treatment due to an immune-related adverse events.
- Untreated or symptomatic brain metastases and leptomeningeal disease Note:
participants with previously treated brain metastases may participate provided they
are radiologically stable, ie, without evidence of progression for at least 4 weeks
by repeat imaging (note that the repeat imaging should be performed during study
screening), clinically stable and without requirement of steroid treatment for at
least 14 days prior to first dose of study treatment.
- Chronic intake of systemic corticosteroids (eg prednisone > 10 mg/day or equivalent)
or any other form of immunosuppressive therapy within 7 days prior to the first dose
of study treatment.
- Has an active autoimmune disease that has required systemic treatment in past 2
years (ie, with use of disease modifying agents, corticosteroids, or
immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or
physiologic corticosteroid replacement therapy for adrenal or pituitary
insufficiency) is not considered a form of systemic treatment and is allowed.
- History of organ transplantation.
- History of (non-infectious) pneumonitis/interstitial lung disease that required
steroids or has current pneumonitis/interstitial lung disease.
- History of any immune-related colitis. Infectious colitis is allowed if evidence of
adequate treatment and clinical recovery exists and at least 3 months interval
observed since diagnosis of colitis.
Other protocol-defined inclusion/exclusion criteria apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope National Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Facility:
Name:
Alliance for Multispecialty Research Kansas City
Address:
City:
Merriam
Zip:
66204
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington University
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Wake Forest University Health Sciences
Address:
City:
Winston-Salem
Zip:
27157
Country:
United States
Status:
Recruiting
Facility:
Name:
South Texas Accelerated Research Therapeutics
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Facility:
Name:
The Queen Elizabeth Hospital
Address:
City:
Woodville South
Zip:
5011
Country:
Australia
Status:
Recruiting
Facility:
Name:
Princess Margaret Cancer Centre
Address:
City:
Toronto
Zip:
M5G 1Z5
Country:
Canada
Status:
Recruiting
Facility:
Name:
Institut Bergonie
Address:
City:
Bordeaux
Zip:
33076
Country:
France
Status:
Recruiting
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa-shi
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
138-736
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Radboud Universitair Medisch Centrum
Address:
City:
Nijmegen
Zip:
6525 GA
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Erasmus Medisch Centrum
Address:
City:
Rotterdam
Zip:
3015 CE
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Address:
City:
Warszawa
Zip:
02-781
Country:
Poland
Status:
Recruiting
Facility:
Name:
Hospital Universitari Vall d Hebron
Address:
City:
Barcelona
Zip:
08023
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Clinic i Provincial de Barcelona
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Ramon y Cajal
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Recruiting
Facility:
Name:
Istituto Oncologico della Svizzera Italiana
Address:
City:
Bellinzona
Zip:
6500
Country:
Switzerland
Status:
Recruiting
Facility:
Name:
Kantonsspital Sankt Gallen
Address:
City:
St. Gallen
Zip:
9007
Country:
Switzerland
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:
March 7, 2024
Completion date:
February 13, 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/NCT06131398
http://www.amgentrials.com
