ERAS-007 Combination Therapy for Gastrointestinal Cancer
(HERKULES-3 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial evaluates the safety and effectiveness of a new treatment called ERAS-007, a potential cancer therapy, used with other cancer drugs for advanced gastrointestinal cancers, specifically colorectal cancer (CRC) and pancreatic cancer (PDAC) with certain mutations. The main goal is to determine safe dosage levels and assess how well this combination works against tumors. The trial includes different arms: some participants will receive ERAS-007 with encorafenib and cetuximab, while others will receive it with palbociclib. It seeks individuals with specific genetic mutations in their cancer who are willing to try new treatments and do not have certain other health issues. 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 therapy.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had anti-cancer therapy within 21 days or 4 half-lives before the first dose of the study drug, whichever is shorter.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that ERAS-007, when combined with encorafenib and cetuximab, is generally safe and well-tolerated. Studies indicate it works effectively without major safety issues. In patients with a specific type of colorectal cancer (BRAF V600E mutation), the treatment proved to be safe.
For the combination of ERAS-007 with palbociclib, research suggests it is also safe. Most side effects were manageable and reversible. This was observed in patients with certain mutations in colorectal and pancreatic cancers (KRASm/NRASm).
Overall, both combinations have been tested in clinical settings and have demonstrated manageable safety profiles. Most side effects are not severe and can be controlled. These findings suggest that ERAS-007, when combined with other treatments, is generally well-tolerated in patients with advanced gastrointestinal cancers.12345Why are researchers excited about this trial's treatments?
Researchers are excited about ERAS-007 because it offers a unique approach for treating gastrointestinal cancers, specifically targeting mutations like BRAFm, KRASm, and NRASm. Unlike standard treatments like chemotherapy and targeted therapies such as cetuximab and encorafenib alone, ERAS-007, when combined with these drugs or with palbociclib, aims to enhance effectiveness by targeting multiple pathways simultaneously. This multi-target strategy could potentially improve outcomes for patients with specific gene mutations, offering a novel mechanism of action that may overcome resistance seen with current therapies. Additionally, its oral administration makes it more convenient compared to traditional intravenous treatments.
What evidence suggests that this trial's treatments could be effective for gastrointestinal cancer?
This trial will evaluate ERAS-007 in combination with other drugs for gastrointestinal cancer. Research has shown that ERAS-007, when combined with encorafenib and cetuximab, produced promising results against a specific type of colorectal cancer with a BRAF V600E mutation in both lab and animal studies. This drug combination is already approved for treating this cancer type, which increases confidence in its potential effectiveness. In this trial, some participants will receive ERAS-007 with encorafenib and cetuximab.
Additionally, ERAS-007 combined with palbociclib has demonstrated encouraging early safety results in patients with colorectal or pancreatic cancer that have KRAS or NRAS mutations. Other participants in this trial will receive ERAS-007 with palbociclib. These drug combinations aim to fight tumors by overcoming resistance, a common challenge in cancer treatment. Early findings suggest these combinations might work well, but more research is needed to confirm their effects.12678Who Is on the Research Team?
Joyce Antal
Principal Investigator
Clinical Development
Are You a Good Fit for This Trial?
This trial is for adults (18+) with advanced gastrointestinal cancers, specifically metastatic colorectal cancer (CRC) or pancreatic ductal adenocarcinoma (PDAC), that have certain mutations. Participants must be in good health otherwise, able to take oral medication, and willing to follow the study procedures. People with brain metastasis, significant heart disease, recent thrombosis or stroke, prior treatment with similar drugs, or those who are pregnant 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
ERAS-007 is administered in combination with other therapies in sequential ascending doses to determine the Maximum Tolerated Dose (MTD) and Recommended Dose (RD)
Dose Expansion
ERAS-007 is administered at the recommended dose in combination with other therapies to evaluate safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ERAS-007
Find a Clinic Near You
Who Is Running the Clinical Trial?
Erasca, Inc.
Lead Sponsor