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Phase I, open-label, multi-center study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation cohort of SPYK04 | Experimental | Patients will receive SPYK04 at escalated dose. |
|
| Expansion part in NSCLC, ovarian cancer and other solid tumors | Experimental | Patients will receive SPYK04 at the recommended dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPYK04 | Drug | SPYK04 capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of SPYK04 (Dose limiting toxicities) [Dose escalation] | Incidence and nature of DLTs | From first dose until the end of Cycle 1 (approximately 35 days) |
| Safety and tolerability of SPYK04 (Adverse Events) [Dose escalation] | Incidence, nature, and severity of adverse events (AEs) as assessed by the NCI CTCAE v5.0 | 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] | Uncorrected QT interval, QTcF, PR duration, QRS interval and RR interval | From first dose until the end of Cycle 1 (approximately 35 days) |
| Safety and tolerability of SPYK04 (Electrocardiograms in triplicate) [Dose escalation] | Heart Rate | From first dose until the end of Cycle 1 (approximately 35 days) |
| Pharmacokinetics of SPYK04 [Dose escalation] | Plasma concentrations of SPYK04 | 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] | Maximum plasma concentration (Cmax) of SPYK04 | 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] |
| Measure | Description | Time Frame |
|---|---|---|
| Preliminary anti-tumor activity of SPYK04 [Dose escalation] | Objective Response | From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first, assessed up to 42 months (study completion) |
| Safety and tolerability of SPYK04 (AEs) [Cohort expansion] |
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Inclusion Criteria:
(Both Part I and Part II)
(Part I only)
(Part II only)
Exclusion Criteria:
(Both Part I and Part II)
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| Name | Affiliation | Role |
|---|---|---|
| Sponsor Chugai Pharmaceutical Co. Ltd | clinical-trials@chugai-pharm.co.jp | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology | Tucson | Arizona | 85711 | United States | ||
| Rocky Mountain Cancer Centers |
Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds\_request.html).
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Time to reach maximum plasma drug concentration (Tmax) of SPYK04 |
| 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] | Area under the concentration versus time curve (AUC) of SPYK04 | 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] | Objective Response Rate (ORR) is defined as proportion of patients who had a confirmed complete response (CR) or partial response (PR), as determined by the investigator with use of Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) | From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first, assessed up to 42 months (study completion) |
Incidence, nature, and severity of AEs assessed by the NCI CTCAE v5.0 |
| From Cycle 1 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] | Disease control rate (DCR) is defined as proportion of patients who had an objective response or stable disease (SD), as determined by the investigator with use of RECIST v1.1 | From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first, assessed up to 42 months (study completion) |
| Preliminary anti-tumor activity of SPYK04 [Cohort expansion] | Progression-free survival (PFS) is defined as the time from the first study treatment to the first occurrence of progression as determined by the investigator using RECIST v1.1 or death from any cause, whichever occurs first | From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first, assessed up to 42 months (study completion) |
| Preliminary anti-tumor activity of SPYK04 [Cohort expansion] | Duration of response (DoR) is defined for patients with a CR or PR at the time from the first documented CR or PR to documented disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first | From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first, assessed up to 42 months (study completion) |
| Pharmacokinetics of SPYK04 [Cohort expansion] | Plasma concentrations of SPYK04 | From Cycle 1 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion) |
| Pharmacokinetics of SPYK04 [Cohort expansion] | Maximum plasma concentration (Cmax) of SPYK04 | From Cycle 1 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion) |
| Pharmacokinetics of SPYK04 [Cohort expansion] | Time to reach maximum plasma drug concentration (Tmax) of SPYK04 | From Cycle 1 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion) |
| Pharmacokinetics of SPYK04 [Cohort expansion] | Area under the concentration versus time curve (AUC) of SPYK04 | From Cycle 1 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion) |
| Pharmacodynamics of SPYK04 [Cohort expansion] | Expression level of pMEK and pERK in solid tumor tissues (e.g., baseline archival or biopsy, and on treatment biopsy) | 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 |
| Lone Tree |
| Colorado |
| 80124 |
| United States |
| Minnesota Oncology | Minneapolis | Minnesota | 55404 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Texas Oncology | Tyler | Texas | 75702 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | United States |
| Froedtert Hospital and the Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| National Cancer Center Hospital East | Kashiwa | Chiba | 277-8577 | Japan |
| Kurume University Hospital | Kurume | Fukuoka | 830-0011 | Japan |
| National Cancer Center Hospital | Chuo Ku | Tokyo | 104-0045 | Japan |
| Cancer Institute Hospital of Japanese Foundation for Cancer Research | Koto-Ku | Tokyo | 135-8550 | Japan |
| National Hospital Organization Kyushu Cancer Center | Fukuoka | 811-1395 | Japan |
| Osaka Prefectural Hospital Organization Osaka International Cancer Center | Osaka | 541-8567 | Japan |