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

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)