A PHASE I STUDY OF SPYK04 IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS
- Conditions
- ocally advanced or metastatic solid tumors
- Registration Number
- JPRN-jRCT2080225265
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- recruiting
- Sex
- All
- Target Recruitment
- 113
(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)
(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 (ncluding, 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>exploratory<br>pharmacokinetics<br>Observation/test
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>exploratory<br>pharmacodynamics<br>Observation/test