SPYK04 for Solid Cancers
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Patients receive SPYK04 at escalated doses to determine safety and pharmacokinetics
Cohort Expansion
Patients receive SPYK04 at the recommended dose to assess pharmacodynamics and anti-tumor activity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- SPYK04
Find a Clinic Near You
Who Is Running the Clinical Trial?
Chugai Pharmaceutical
Lead Sponsor
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