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Completed
NCT04511845
A Dose-Escalation Study of SPYK04 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion).
Conditions: Locally Advanced or Metastatic Solid Tumors
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 85
Sponsor: Chugai Pharmaceutical
Location: Arizona Oncology Tucson Arizona
Summary
Phase I, open-label, multi-center study
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)
Source: ClinicalTrials.gov (NCT04511845). StuddyBuddy aggregates publicly available trial information.