Phase
Condition
Neoplasms
Treatment
SPYK04
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
(Both Part I and Part II)
Age >= 18 years at time of signing informed consent form
ECOG performance status of 0 or 1
Patients with a locally advanced, recurrent, or metastatic solid tumor for whichstandard therapy either does not exist or has proven ineffective or intolerable
(Part I only)
Patients with measurable and/or evaluable disease per RECIST v1.1
Patients with MAPK pathway alterations positive solid tumor (i.e., BRAF, K/N/H-RASmutations)
(Part II only)
Patients with measurable disease per RECIST v1.1
Patients with KRAS mutated NSCLC (NSCLC cohort)
Patients with KRAS mutated Ovarian Cancer (Ovarian Cancer cohort)
Patients with RAS mutated solid tumor (Biopsy cohort)
Exclusion
Exclusion Criteria:
(Both Part I and Part II)
Significant cardiovascular disease, such as New York Heart Association (NYHA)cardiac disease (Class II or greater), unstable angina, or myocardial infarctionwithin the previous 6 months or unstable arrhythmias within the previous 3 months
Patients with primary central nervous system (CNS) malignancy, untreated CNSmetastases requiring any anti-tumor treatment, or active CNS metastases
Patients with current severe, uncontrolled systemic disease (including, but notlimited to, clinically significant cardiovascular disease, pulmonary disease, orrenal disease, ongoing or active infection)
Patients with a history or complication of interstitial lung disease (ILD)
Study Design
Connect with a study center
National Cancer Center Hospital East
Kashiwa, Chiba 277-8577
JapanSite Not Available
Kurume University Hospital
Kurume, Fukuoka 830-0011
JapanSite Not Available
National Cancer Center Hospital
Chuo Ku, Tokyo 104-0045
JapanSite Not Available
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-Ku, Tokyo 135-8550
JapanSite Not Available
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
JapanSite Not Available
Osaka Prefectural Hospital Organization Osaka International Cancer Center
Osaka, 541-8567
JapanSite Not Available
Arizona Oncology
Tucson, Arizona 85711
United StatesSite Not Available
Rocky Mountain Cancer Centers
Lone Tree, Colorado 80124
United StatesSite Not Available
Minnesota Oncology
Minneapolis, Minnesota 55404
United StatesSite Not Available
Rhode Island Hospital
Providence, Rhode Island 02903
United StatesSite Not Available
MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
Texas Oncology
Tyler, Texas 75702
United StatesSite Not Available
University of Virginia
Charlottesville, Virginia 22903
United StatesSite Not Available
Virginia Cancer Specialists
Fairfax, Virginia 22031
United StatesSite Not Available
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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