A Dose-Escalation Study of SPYK04 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion).
NCT ID: NCT04511845
Last Updated: 2025-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
113 participants
INTERVENTIONAL
2020-09-10
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dose escalation cohort of SPYK04
Patients will receive SPYK04 at escalated dose.
SPYK04
SPYK04 capsule
Expansion part in NSCLC, ovarian cancer and other solid tumors
Patients will receive SPYK04 at the recommended dose.
SPYK04
SPYK04 capsule
Interventions
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SPYK04
SPYK04 capsule
Eligibility Criteria
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Inclusion Criteria
* 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 which standard 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-RAS mutations)
(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 Criteria
* Significant cardiovascular disease, such as New York Heart Association (NYHA) cardiac disease (Class II or greater), unstable angina, or myocardial infarction within the previous 6 months or unstable arrhythmias within the previous 3 months
* Patients with primary central nervous system (CNS) malignancy, untreated CNS metastases requiring any anti-tumor treatment, or active CNS metastases
* Patients with current severe, uncontrolled systemic disease (including, but not limited to, clinically significant cardiovascular disease, pulmonary disease, or renal disease, ongoing or active infection)
* Patients with a history or complication of interstitial lung disease (ILD)
18 Years
ALL
No
Sponsors
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Chugai Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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Arizona Oncology
Tucson, Arizona, United States
Rocky Mountain Cancer Centers
Lone Tree, Colorado, United States
Minnesota Oncology
Minneapolis, Minnesota, United States
Rhode Island Hospital
Providence, Rhode Island, United States
MD Anderson Cancer Center
Houston, Texas, United States
Texas Oncology
Tyler, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
National Cancer Center Hospital
Chuo Ku, Tokyo, Japan
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-Ku, Tokyo, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, , Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Center
Osaka, , Japan
Countries
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Other Identifiers
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SPK101JG
Identifier Type: -
Identifier Source: org_study_id
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