Runimotamab for Solid Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines a new treatment called Runimotamab for individuals with certain advanced cancers that exhibit high levels of the HER2 protein. The researchers aim to assess the safety and tolerability of Runimotamab, both alone and in combination with another drug, Trastuzumab. Participants will receive varying doses to determine the optimal amount. This trial may suit individuals whose HER2-positive breast or gastric cancers have not responded to standard treatments. 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.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on medications that prolong the QT interval (a heart rhythm measurement), you may need to stop those.
Is there any evidence suggesting that Runimotamab is likely to be safe for humans?
Research has shown that Runimotamab generally has a manageable safety profile based on previous studies. When combined with Trastuzumab, it was usually well-tolerated, even by patients who had undergone extensive treatment for HER2-positive breast cancer.
However, treatments like Runimotamab can sometimes cause side effects such as cytokine release syndrome (CRS), leading to flu-like symptoms. Earlier studies reported these side effects as manageable.
Since this trial is in an early phase, the main goal is to assess the safety and tolerability of Runimotamab. Researchers continue to gather information on how participants react to the treatment.12345Why do researchers think this study treatment might be promising?
Runimotamab is unique because it targets solid tumors by tackling them in a novel way. Unlike traditional treatments like chemotherapy, which can affect both healthy and cancerous cells, runimotamab is designed to hone in more precisely on cancer cells, potentially reducing side effects. Researchers are excited about its potential to improve outcomes by using a targeted approach that may offer a more personalized and efficient treatment option. This precision targeting might lead to better results with fewer unwanted effects, making it a promising candidate for patients with solid tumors.
What evidence suggests that Runimotamab might be an effective treatment for HER2-expressing cancers?
Research has shown that Runimotamab, a drug that aids the immune system in fighting cancer, might effectively treat various solid tumors. These drugs have shown promise even for difficult-to-treat cancers. In this trial, participants will receive Runimotamab either in a dose escalation phase to determine the maximum tolerated dose or in a dose expansion phase based on the identified dose. One study found that combining Runimotamab with Trastuzumab worked well in patients with HER2-positive breast cancer, proving more effective than Runimotamab alone. Additionally, drugs like Runimotamab have demonstrated success in early trials. Overall, evidence suggests that Runimotamab could help treat solid tumors, especially when combined with Trastuzumab.12678
Who Is on the Research Team?
Clinical Trials
Principal Investigator
Genentech, Inc.
Are You a Good Fit for This Trial?
This trial is for people with advanced or metastatic HER2-expressing cancers who have tried at least one standard therapy without success, or can't tolerate it. They should expect to live at least 12 weeks, be in good physical condition (ECOG 0-1), and have a heart pumping function (LVEF) of at least 50%. People with untreated brain metastases, significant heart/lung problems, certain infections like HIV/HCV, uncontrolled diabetes, or those pregnant cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants will be assigned sequentially to escalating doses of runimotamab up to the maximum tolerated dose (MTD)
Dose Expansion
Participants will receive runimotamab based on the MTD or maximum allowed dose (MAD) identified during dose escalation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Runimotamab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Genentech, Inc.
Lead Sponsor
Ashley Magargee
Genentech, Inc.
Chief Executive Officer since 2024
MBA from Harvard University, BA from Princeton University
Levi Garraway
Genentech, Inc.
Chief Medical Officer since 2021
MD, PhD