A PHASE I STUDY OF SPYK04 IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS

A PHASE I, OPEN-LABEL, MULTICENTER, DOSE ESCALATION AND COHORT EXPANSION STUDY OF SPYK04 AS MONOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225265

Enrollment

113

Registered

2020-07-06

Start date

2020-11-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced or metastatic solid tumors

Interventions

investigational material(s) Generic name etc : SPYK04 INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material

Eligibility

Sex/Gender

All

Inclusion 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

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 (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)

Design outcomes

Primary

Measure	Time frame
safety efficacy exploratory pharmacokinetics Observation/test	—

Secondary

Measure	Time frame
safety efficacy exploratory pharmacodynamics Observation/test	—

Countries

Japan, the US

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026