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SPYK04 for Solid Cancers

Phase 1

Recruiting

Research Sponsored by Chugai Pharmaceutical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with a locally advanced, recurrent, or metastatic solid tumor for which standard therapy either does not exist or has proven ineffective or intolerable

ECOG performance status of 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first, assessed up to 42 months (study completion)

Awards & highlights

Study Summary

This trial is a Phase I study, which means that it is the first time this particular treatment is being tested in humans. The study is open-label, meaning that both the participants and the researchers know which treatment the participants are receiving. The study is multi-center, meaning that it is taking place at more than one research center.

Who is the study for?

This trial is for adults over 18 with advanced solid tumors where standard treatments failed or aren't suitable. They must be relatively healthy, meaning they can do daily activities without much help (ECOG status of 0 or 1). People with serious lung disease, recent heart problems, uncontrolled illnesses like heart disease or infections, or brain cancer/tumors needing treatment can't join.Check my eligibility

What is being tested?

The study tests different doses of a new drug called SPYK04 on patients to see how much they can take and what effects it has. It's an early-phase trial (Phase I), which means it's one of the first times this drug is being given to people. The study is open-label and multi-center, so everyone knows what treatment they're getting and it's happening in several hospitals.See study design

What are the potential side effects?

Since SPYK04 is new and this is a dose-escalation study to find out the best dose, specific side effects are not yet fully known. Generally, such trials look out for any signs of organ damage, allergic reactions, fatigue, nausea among others as potential side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has spread, and standard treatments haven't worked or can't be used.

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I am fully active or can carry out light work.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first, assessed up to 42 months (study completion)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first, assessed up to 42 months (study completion)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first, assessed up to 42 months (study completion) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pharmacokinetics of SPYK04 [Dose escalation]

Safety and tolerability of SPYK04 (Adverse Events) [Dose escalation]

Safety and tolerability of SPYK04 (Dose limiting toxicities) [Dose escalation]

+1 more

Secondary outcome measures

Pharmacodynamics of SPYK04 [Cohort expansion]

Pharmacokinetics of SPYK04 [Cohort expansion]

Preliminary anti-tumor activity of SPYK04 [Cohort expansion]

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Expansion part in NSCLC, ovarian cancer and other solid tumorsExperimental Treatment1 Intervention

Patients will receive SPYK04 at the recommended dose.

Group II: Dose escalation cohort of SPYK04Experimental Treatment1 Intervention

Patients will receive SPYK04 at escalated dose.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Chugai PharmaceuticalLead Sponsor

95 Previous Clinical Trials

21,591 Total Patients Enrolled

Sponsor Chugai Pharmaceutical Co. LtdStudy Directorclinical-trials@chugai-pharm.co.jp

9 Previous Clinical Trials

757 Total Patients Enrolled

Media Library

SPYK04 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04511845 — Phase 1

Solid Tumors Research Study Groups: Expansion part in NSCLC, ovarian cancer and other solid tumors, Dose escalation cohort of SPYK04

Solid Tumors Clinical Trial 2023: SPYK04 Highlights & Side Effects. Trial Name: NCT04511845 — Phase 1

SPYK04 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04511845 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available opportunities to participate in this research project?

"Yes, according to information listed on clinicaltrials.gov this experimental medical study is still accepting patients for participation. First posted in September of 2020 and updated as recently as March 2022, the trial requires 90 volunteers across two sites."

Answered by AI

What are the chief aims of this medical experiment?

"The primary goal of this trial, assessed over a time frame extending from Cycle 0 Day 1 until 28 days after the final dose and lasting up to 42 months (study completion), is to evaluate SPYK04's safety and tolerability through electrocardiograms. Secondary objectives include assessing SPYK04's pharmacodynamics with regards to pMEK/pERK expression in solid tumors, its overall safety via AE analysis using NCI CTCAE v5.0 standards, and preliminary anti-tumor efficacy by measuring objective responses."

Answered by AI

How many participants are participating in this medical experiment?

"Affirmative. The information featured on clinicaltrials.gov suggests that this medical experiment is presently recruiting participants, having initially been posted in September 10th 2020 and most recently updated on March 7th 2022. This study seeks to enrol 90 patients from two separate sites."

Answered by AI

Is SPYK04 generally perceived as a safe medication by medical professionals?

"As this is a Phase 1 clinical trial, meaning that there is little data to support the safety and efficacy of SPYK04, we have assigned it a score of 1."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "A Dose-Escalation Study of SPYK04 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion).". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04511845.