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

NCT04511845

CompletedPhase 1

Sponsor: Chugai Pharmaceutical

Conditions: Locally Advanced or Metastatic Solid Tumors

Interventions: SPYK04

Countries: United States, Japan

Phase I, open-label, multi-center study

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 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:

(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)

Locations (15)

Tucson, Arizona, United States
Lone Tree, Colorado, United States
Minneapolis, Minnesota, United States
Providence, Rhode Island, United States
Houston, Texas, United States
Tyler, Texas, United States
Charlottesville, Virginia, United States
Fairfax, Virginia, United States
Milwaukee, Wisconsin, United States
Kashiwa, Chiba, Japan
Kurume, Fukuoka, Japan
Chuo Ku, Tokyo, Japan
Koto-Ku, Tokyo, Japan
Fukuoka, Japan
Osaka, Japan