ERAS-601 for Advanced Solid Cancer
(FLAGSHP-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called ERAS-601 for individuals with advanced or metastatic solid tumors. The main goal is to determine the safety of ERAS-601 and the optimal dose, whether administered alone or with other cancer treatments. The trial includes several parts, some focusing on ERAS-601 alone and others combining it with drugs like cetuximab or pembrolizumab. It seeks participants with advanced cancer who have no effective standard treatment options and can take oral medications. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently receiving another study therapy or have taken an investigational agent within 4 weeks of starting this trial.
Is there any evidence suggesting that ERAS-601 is likely to be safe for humans?
In earlier studies, researchers tested ERAS-601 for safety as a treatment for advanced solid tumors. When used alone, the research has primarily focused on determining the right dose. Patients have experienced varied responses, but more information is still being gathered about specific side effects and tolerance.
In combination with cetuximab, another cancer treatment, ERAS-601 has shown promising results in the lab. Cetuximab is already used for certain cancers, such as colorectal cancer and head and neck cancer, suggesting that the combination might be safe. However, more real-world data is needed.
ERAS-601 is also being tested with pembrolizumab, a treatment effective for head and neck cancers. Pembrolizumab is approved for these cancers, indicating the mix could be safe, but further study results are needed to confirm this.
Since the current study is in an early phase, it focuses on understanding safety and determining a safe dose. This means some side effects may remain unknown, but the trial will provide more detailed information.12345Why are researchers excited about this trial's treatments?
Researchers are excited about ERAS-601 for advanced solid cancers because it introduces a novel mechanism of action targeting specific cancer pathways, which could potentially offer an advantage over current treatments like chemotherapy, radiation, and standard immunotherapies. Unlike traditional therapies that often have broad and aggressive effects, ERAS-601 is designed to precisely target and disrupt cancer cell growth, potentially leading to more effective results with fewer side effects. Additionally, the trial is exploring ERAS-601 in combination with cetuximab and pembrolizumab, which could enhance its efficacy by utilizing complementary mechanisms, opening up new possibilities for treating hard-to-treat cancers like head and neck squamous cell carcinoma and colorectal cancer.
What evidence suggests that ERAS-601 could be an effective treatment for advanced solid cancer?
Research has shown that ERAS-601 may help treat advanced or spreading solid tumors. In one study, 23% of patients with certain genetic changes saw their tumors shrink. Another study found that 7 out of 8 patients experienced some tumor reduction. In this trial, some participants will receive ERAS-601 with cetuximab, which early research found to be safe and effective. Others will receive ERAS-601 combined with pembrolizumab, a treatment for some lung cancers, which might enhance its effectiveness, especially for head and neck cancers. These results suggest ERAS-601 could be helpful, but more research is needed.12367
Who Is on the Research Team?
Les Brail, PhD
Principal Investigator
Clinical Development
Are You a Good Fit for This Trial?
This trial is for adults (18+) with advanced or metastatic solid tumors who have no standard treatment options left, can't tolerate the usual treatments, or choose not to use them. Participants must be able to take oral medication and have a good performance status, meaning they're fully active or restricted in physically strenuous activity but can still carry out work of a light nature.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
ERAS-601 monotherapy is administered in sequential ascending doses to determine the Maximum Tolerated Dose (MTD) and/or recommended dose (RD)
Dose Expansion
Once the MTD/RD is determined, ERAS-601 monotherapy is expanded to more participants with specific molecular alterations
Combination Therapy Dose Escalation
ERAS-601 is administered with cetuximab or pembrolizumab in sequential ascending doses to determine the combination therapy MTD/RD
Combination Therapy Dose Expansion
Once the combination therapy MTD/RD is determined, the treatment is expanded to more participants with specific cancer types
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ERAS-601
Find a Clinic Near You
Who Is Running the Clinical Trial?
Erasca, Inc.
Lead Sponsor