Locally Advanced or Metastatic Solid TumorsPhase 1NCT04511845
A Dose-Escalation Study of SPYK04 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion).
A Phase 1 study testing SPYK04 in people with Locally Advanced or Metastatic Solid Tumors, run by Chugai Pharmaceutical at 15 sites in 2 countries.
Trial summary
Phase I, open-label, multi-center study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Solid Tumors
- What is being tested?
- SPYK04
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 10 Sep 2020to 18 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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
Show all 12Show fewer
- 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)
Who cannot join
- (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 locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States9 sites
University of Virginia
Charlottesville, Virginia, 22903
Virginia Cancer Specialists
Fairfax, Virginia, 22031
MD Anderson Cancer Center
Houston, Texas, 77030
Rocky Mountain Cancer Centers
Lone Tree, Colorado, 80124
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Minnesota Oncology
Minneapolis, Minnesota, 55404
Rhode Island Hospital
Providence, Rhode Island, 02903
Arizona Oncology
Tucson, Arizona, 85711
Texas Oncology
Tyler, Texas, 75702
Japan6 sites
National Cancer Center Hospital
Chuo Ku, Tokyo, 104-0045
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-Ku, Tokyo, 135-8550
Kurume University Hospital
Kurume, Fukuoka, 830-0011
Osaka Prefectural Hospital Organization Osaka International Cancer Center
Osaka, 541-8567
About this study
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
Phase I, open-label, multi-center study
- Being tested
- SPYK04
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPYK04Drug
SPYK04 capsule
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation cohort of SPYK04 | Experimental | Patients will receive SPYK04 at escalated dose. Receives: Drug: SPYK04 |
| Expansion part in NSCLC, ovarian cancer and other solid tumors | Experimental | Patients will receive SPYK04 at the recommended dose. Receives: Drug: SPYK04 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of SPYK04 (Dose limiting toxicities) [Dose escalation]
Incidence and nature of DLTs
Measured: 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
Measured: 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
Measured: From first dose until the end of Cycle 1 (approximately 35 days)
Safety and tolerability of SPYK04 (Electrocardiograms in triplicate) [Dose escalation]
Heart Rate
Measured: From first dose until the end of Cycle 1 (approximately 35 days)
Pharmacokinetics of SPYK04 [Dose escalation]
Plasma concentrations of SPYK04
Measured: 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
Measured: 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]
Time to reach maximum plasma drug concentration (Tmax) of SPYK04
Measured: 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
Measured: 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)
Measured: From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first, assessed up to 42 months (study completion)
Secondary outcomes (10)
Preliminary anti-tumor activity of SPYK04 [Dose escalation]
Objective Response
Measured: 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]
Incidence, nature, and severity of AEs assessed by the NCI CTCAE v5.0
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start10 Sep 2020
- Primary completion18 Jun 2026
- Study completion18 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sponsor Chugai Pharmaceutical Co. Ltd, Study director, clinical-trials@chugai-pharm.co.jp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511845
- Sponsor's protocol ID
- SPK101JG
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2020
- Last updated
- 30 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04511845
- Acronym / sponsor ID
- SPK101JG
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 18 Jun 2026 (actual)
- Study completion
- 18 Jun 2026 (actual)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I, open-label, multi-center study
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose escalation cohort of SPYK04 | Experimental | Drug: SPYK04Patients will receive SPYK04 at escalated dose. |
| Expansion part in NSCLC, ovarian cancer and other solid tumors | Experimental | Drug: SPYK04Patients will receive SPYK04 at the recommended dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- (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)
Key exclusion criteria (5 listed)
- (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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPYK04SPYK04 capsule | Drug | Dose escalation cohort of SPYK04, Expansion part in NSCLC, ovarian cancer and other solid tumors |
Primary outcome
Safety and tolerability of SPYK04 (Dose limiting toxicities) [Dose escalation]
Time frame: From first dose until the end of Cycle 1 (approximately 35 days)
Incidence and nature of DLTs
Safety and tolerability of SPYK04 (Adverse Events) [Dose escalation]
Time frame: From Cycle 0 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion)
Incidence, nature, and severity of adverse events (AEs) as assessed by the NCI CTCAE v5.0
Safety and tolerability of SPYK04 (Electrocardiograms in triplicate) [Dose escalation]
Time frame: From first dose until the end of Cycle 1 (approximately 35 days)
Uncorrected QT interval, QTcF, PR duration, QRS interval and RR interval
Safety and tolerability of SPYK04 (Electrocardiograms in triplicate) [Dose escalation]
Time frame: From first dose until the end of Cycle 1 (approximately 35 days)
Heart Rate
Pharmacokinetics of SPYK04 [Dose escalation]
Time frame: From Cycle 0 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion)
Plasma concentrations of SPYK04
Pharmacokinetics of SPYK04 [Dose escalation]
Time frame: From Cycle 0 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion)
Maximum plasma concentration (Cmax) of SPYK04
Pharmacokinetics of SPYK04 [Dose escalation]
Time frame: From Cycle 0 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion)
Time to reach maximum plasma drug concentration (Tmax) of SPYK04
Pharmacokinetics of SPYK04 [Dose escalation]
Time frame: From Cycle 0 Day 1 until 28 days after the last dose of study treatment, assessed up to 42 months (study completion)
Area under the concentration versus time curve (AUC) of SPYK04
Preliminary anti-tumor activity of SPYK04 [Cohort expansion]
Time frame: From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first, assessed up to 42 months (study completion)
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)
10 secondary outcomes
Preliminary anti-tumor activity of SPYK04 [Dose escalation]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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 frame: 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 frame: 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 frame: 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]
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sponsor Chugai Pharmaceutical Co. Ltd study director
clinical-trials@chugai-pharm.co.jp
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SPYK04 in people with Locally Advanced or Metastatic Solid Tumors, run by Chugai Pharmaceutical at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of SPYK04 (Dose limiting toxicities) [Dose escalation] (time frame: From first dose until the end of Cycle 1 (approximately 35 days)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.