A Dose-Escalation Study of SPYK04 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion).

Completed · Phase 1

Conditions studied: Locally Advanced or Metastatic Solid Tumors

In brief

Phase I, open-label, multi-center study

Key facts

Study ID

NCT04511845

Run by

Chugai Pharmaceutical

People needed

85

Starts

2020-09-10

Expected to finish

2026-06-18

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• (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 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)

You may not qualify if…

• (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 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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