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

Chugai Pharmaceutical

Status and phase: Active, not recruiting; Phase 1

Conditions: Locally Advanced or Metastatic Solid Tumors

Treatments: Drug: SPYK04

Study type: Interventional

Funder types: Industry

Identifiers

NCT04511845

SPK101JG

Details and patient eligibility

About

Phase I, open-label, multi-center study

Enrollment: 113 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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113 participants in 2 patient groups

Dose escalation cohort of SPYK04

Experimental group

Description:

Patients will receive SPYK04 at escalated dose.

Treatment:

Drug: SPYK04

Expansion part in NSCLC, ovarian cancer and other solid tumors

Experimental group

Description:

Patients will receive SPYK04 at the recommended dose.

Treatment:

Drug: SPYK04