SPYK04 for Solid Cancers

Recruiting at 14 trial locations

Overseen By Clinical trials information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Chugai Pharmaceutical

Disqualifiers: Cardiovascular disease, CNS malignancy, ILD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

113 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to evaluate the safety and initial effectiveness of a new treatment. Specific details about the intervention, patient group, and how the treatment works are not provided.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research Team

Sponsor Chugai Pharmaceutical Co. Ltd

Principal Investigator

[e-mail]

Eligibility Criteria

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.

Inclusion Criteria

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

I am fully active or can carry out light work.

I am 18 years old or older.

Exclusion Criteria

I do not have any severe, uncontrolled illnesses like heart, lung, or kidney diseases.

I have a history of lung scarring or ILD.

I do not have serious heart conditions like recent heart attacks or unstable heart rhythms.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Patients receive SPYK04 at escalated doses to determine safety and pharmacokinetics

35 days

Multiple visits for dose administration and monitoring

Cohort Expansion

Patients receive SPYK04 at the recommended dose to assess pharmacodynamics and anti-tumor activity

Up to 42 months

Regular visits for treatment and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days after the last dose

Treatment Details

Interventions

• SPYK04

Trial Overview 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.

Participant Groups

Group I: Expansion part in NSCLC, ovarian cancer and other solid tumors Experimental Treatment 1 Intervention

Patients will receive SPYK04 at the recommended dose.

Group II: Dose escalation cohort of SPYK04 Experimental Treatment 1 Intervention

Patients will receive SPYK04 at escalated dose.

Who Is Running the Clinical Trial?

Chugai Pharmaceutical

Lead Sponsor

Trials

105

Recruited

25,000+

Dr. Osamu Okuda

Chugai Pharmaceutical

Chief Executive Officer since 2020

MD from Kyoto University

Dr. Mariko Y. Momoi

Chugai Pharmaceutical

Chief Medical Officer

MD from Jichi Medical University