Status:
ACTIVE_NOT_RECRUITING
A Dose-Escalation Study of SPYK04 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion).
Lead Sponsor:
Chugai Pharmaceutical
Conditions:
Locally Advanced or Metastatic Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Phase I, open-label, multi-center study
Eligibility Criteria
Inclusion
- (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
- (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)
Key Trial Info
Start Date :
September 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT04511845
Start Date
September 10 2020
End Date
September 30 2026
Last Update
July 14 2025
Active Locations (15)
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1
Arizona Oncology
Tucson, Arizona, United States, 85711
2
Rocky Mountain Cancer Centers
Lone Tree, Colorado, United States, 80124
3
Minnesota Oncology
Minneapolis, Minnesota, United States, 55404
4
Rhode Island Hospital
Providence, Rhode Island, United States, 02903