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Clinical trial

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

ID
Name
SPK101JG
Description
Phase I, open-label, multi-center study
Trial arms
Trial start
2020-09-10
Estimated PCD
2024-06-30
Trial end
2024-09-30
Status
Recruiting
Phase
Early phase I
Treatment
SPYK04
SPYK04 capsule
Arms:
Dose escalation cohort of SPYK04, Expansion part in NSCLC, ovarian cancer and other solid tumors
Size
113
Primary endpoint
Safety and tolerability of SPYK04 (Dose limiting toxicities) [Dose escalation]
From first dose until the end of Cycle 1 (approximately 35 days)
Safety and tolerability of SPYK04 (Adverse Events) [Dose escalation]
From Cycle 0 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion)
Safety and tolerability of SPYK04 (Electrocardiograms in triplicate) [Dose escalation]
From first dose until the end of Cycle 1 (approximately 35 days)
Safety and tolerability of SPYK04 (Electrocardiograms in triplicate) [Dose escalation]
From first dose until the end of Cycle 1 (approximately 35 days)
Pharmacokinetics of SPYK04 [Dose escalation]
From Cycle 0 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion)
Pharmacokinetics of SPYK04 [Dose escalation]
From Cycle 0 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion)
Pharmacokinetics of SPYK04 [Dose escalation]
From Cycle 0 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion)
Pharmacokinetics of SPYK04 [Dose escalation]
From Cycle 0 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion)
Preliminary anti-tumor activity of SPYK04 [Cohort expansion]
From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first, assessed up to 42 months (study completion)
Eligibility 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: (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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 113, 'type': 'ESTIMATED'}}
Updated at
2023-10-27

1 organization

1 product

1 indication

Product
SPYK04
Indication
Metastatic Solid Tumors
Organization
Chugai Pharmaceutical