SPYK04 for Solid Cancers

Not currently recruiting at 14 trial locations
Ct
Overseen ByClinical trials information
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Chugai Pharmaceutical
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new treatment called SPYK04 for various solid cancers. It includes two parts: one where patients receive increasing doses and another where patients with specific cancer types or mutations, such as KRAS-mutated lung and ovarian cancer, receive a recommended dose. People with advanced solid tumors that haven't responded to standard treatments, especially those with certain gene mutations, might be a good fit.

As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that SPYK04 is likely to be safe for humans?

Research has shown that SPYK04 is generally well-tolerated by patients with advanced solid tumors. Studies found that doses up to 1.3 mg per day were manageable. Some patients experienced partial responses, with their tumors shrinking. Although specific side effects weren't detailed, reaching this dose level without major issues suggests reasonable safety. This treatment remains under study, and the trial aims to further understand its safety and effectiveness.12345

Why do researchers think this study treatment might be promising?

SPYK04 is unique because it offers a fresh approach to treating solid tumors, including non-small cell lung cancer (NSCLC) and ovarian cancer. Unlike traditional chemotherapy, which attacks both healthy and cancerous cells, SPYK04 targets specific cancer cell pathways, potentially reducing side effects. Researchers are particularly excited about its flexible dosing strategy, which allows for escalation to find the most effective and safest dose for each patient. This precision approach may lead to better outcomes and improved quality of life for people dealing with these challenging cancers.

What evidence suggests that SPYK04 might be an effective treatment for solid cancers?

Research has shown that SPYK04 is a promising new treatment for solid tumors. It targets specific parts of cancer cells, known as RAF and MEK proteins, to help stop cell growth. In this trial, participants will receive SPYK04 in different treatment arms. Early results indicated that patients tolerated SPYK04 well at doses up to 1.3 mg per day. Encouragingly, some patients with advanced solid tumors experienced partial responses, meaning their tumors became smaller. This suggests that SPYK04 could effectively treat certain solid cancers.23567

Who Is on the Research Team?

SC

Sponsor Chugai Pharmaceutical Co. Ltd

Principal Investigator

clinical-trials@chugai-pharm.co.jp

Are You a Good Fit for This Trial?

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.

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.
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Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Expansion part in NSCLC, ovarian cancer and other solid tumorsExperimental Treatment1 Intervention
Group II: Dose escalation cohort of SPYK04Experimental Treatment1 Intervention

Find a Clinic Near You

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

Citations

SPYK04, a novel RAF-MEK molecular glue: Dose ...Conclusions: SPYK04 was tolerated at doses up to 1.3 mg/day in patients with advanced solid tumors. PRs were observed in two patients with ...
A Dose-Escalation Study of SPYK04 in Patients With Locally ...Patients will receive SPYK04 at escalated dose. Expansion part in NSCLC, ovarian cancer and other solid tumors ... SB17170 Phase 1 Clinical Trial in Solid Tumors.
Clinical Trial: NCT04511845A dose-escalation study of SPYK04 in patients with locally advanced or metastatic solid tumors (with expansion).
SPYK04 for Solid Cancers · Info for ParticipantsThe study tests different doses of a new drug called SPYK04 on patients to see how much they can take and what effects it has.
SPYK04, a novel RAF-MEK molecular glue: Dose ...Despite their great success in treating blood cancers, CAR-T therapies exhibit significantly lower effectiveness in treating solid tumors.
NCT04511845 | A Dose-Escalation Study of SPYK04 in ...Expansion part in NSCLC, ovarian cancer and other solid tumors. Patients will receive SPYK04 at the recommended dose. Intervention/Treatment, Drug : SPYK04.
SPYK04 / RocheSPYK04, a novel RAF-MEK molecular glue: Dose escalation (DE) in first-in-human study for MAPK pathway-altered solid tumors.
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