Clinical trial NCT04511845: A Dose-Escalation Study of SPYK04 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion).
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Locally Advanced or Metastatic Solid Tumors
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2020-08-13
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase I, open-label, multi-center study


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)

Primary outcomes:
measure: Safety and tolerability of SPYK04 (Dose limiting toxicities) [Dose escalation]
timeFrame: From first dose until the end of Cycle 1 (approximately 35 days)
measure: Safety and tolerability of SPYK04 (Adverse Events) [Dose escalation]
timeFrame: From Cycle 0 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion)
measure: Safety and tolerability of SPYK04 (Electrocardiograms in triplicate) [Dose escalation]
timeFrame: From first dose until the end of Cycle 1 (approximately 35 days)
measure: Safety and tolerability of SPYK04 (Electrocardiograms in triplicate) [Dose escalation]
timeFrame: From first dose until the end of Cycle 1 (approximately 35 days)
measure: Pharmacokinetics of SPYK04 [Dose escalation]
timeFrame: From Cycle 0 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion)
measure: Pharmacokinetics of SPYK04 [Dose escalation]
timeFrame: From Cycle 0 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion)
measure: Pharmacokinetics of SPYK04 [Dose escalation]
timeFrame: From Cycle 0 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion)
measure: Pharmacokinetics of SPYK04 [Dose escalation]
timeFrame: From Cycle 0 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion)
measure: Preliminary anti-tumor activity of SPYK04 [Cohort expansion]
timeFrame: From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first, assessed up to 42 months (study completion)
Secondary outcomes:
measure: Preliminary anti-tumor activity of SPYK04 [Dose escalation]
timeFrame: From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first, assessed up to 42 months (study completion)
measure: Safety and tolerability of SPYK04 (AEs) [Cohort expansion]
timeFrame: From Cycle 1 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion)
measure: Preliminary anti-tumor activity of SPYK04 [Cohort expansion]
timeFrame: From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first, assessed up to 42 months (study completion)
measure: Preliminary anti-tumor activity of SPYK04 [Cohort expansion]
timeFrame: From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first, assessed up to 42 months (study completion)
measure: Preliminary anti-tumor activity of SPYK04 [Cohort expansion]
timeFrame: From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first, assessed up to 42 months (study completion)
measure: Pharmacokinetics of SPYK04 [Cohort expansion]
timeFrame: From Cycle 1 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion)
measure: Pharmacokinetics of SPYK04 [Cohort expansion]
timeFrame: From Cycle 1 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion)
measure: Pharmacokinetics of SPYK04 [Cohort expansion]
timeFrame: From Cycle 1 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion)
measure: Pharmacokinetics of SPYK04 [Cohort expansion]
timeFrame: From Cycle 1 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion)
measure: Pharmacodynamics of SPYK04 [Cohort expansion]
timeFrame: From screening until the time of partial response or stable disease lasting for more than 4 months, and the time of progressive disease, if possible, an average of 1 year
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Oncology
state: Arizona
city: Lone Tree
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Minneapolis
country: United States
facility: Minnesota Oncology
state: Minnesota
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Tyler
country: United States
facility: Texas Oncology
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Milwaukee
country: United States
facility: Froedtert Hospital and the Medical College of Wisconsin
state: Wisconsin
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Chuo Ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto-Ku
country: Japan
facility: Cancer Institute Hospital of Japanese Foundation for Cancer Research
state: Tokyo
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Osaka
country: Japan
facility: Osaka Prefectural Hospital Organization Osaka International Cancer Center
Study officials:
affiliation: clinical-trials@chugai-pharm.co.jp
name: Sponsor Chugai Pharmaceutical Co. Ltd
role: STUDY_DIRECTOR
References: