Runimotamab for Solid Tumors

Not currently recruiting at 45 trial locations
RS
RS
Overseen ByReference Study ID Number: GO40311 https://forpatients.roche.com/
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 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.12345

Why 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?

CT

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

My breast cancer is HER2 positive and has either returned or didn't respond to treatment.
My cancer is HER2-positive and has not responded well to standard treatments.
My stomach cancer is advanced, cannot be surgically removed, and has been treated with specific drugs including trastuzumab.
See 5 more

Exclusion Criteria

I have Hepatitis C.
I am not on medications that affect heart rhythm.
I have had a previous transplant of stem cells or an organ.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants will be assigned sequentially to escalating doses of runimotamab up to the maximum tolerated dose (MTD)

8-12 weeks

Dose Expansion

Participants will receive runimotamab based on the MTD or maximum allowed dose (MAD) identified during dose escalation

12-16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Runimotamab
Trial Overview The study tests Runimotamab alone and combined with Trastuzumab on participants with HER2-positive cancers. It aims to understand the safety and how the body processes these drugs when given through an IV.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment3 Interventions
Group II: Dose EscalationExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Genentech, Inc.

Lead Sponsor

Trials
1,578
Recruited
569,000+
Ashley Magargee profile image

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway profile image

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Published Research Related to This Trial

Immunotherapy, particularly immune checkpoint inhibitors, has significantly improved treatment outcomes for high-risk resectable and metastatic melanoma, showcasing its effectiveness across various cancer types.
The success of immunotherapy in melanoma has led to its approval and evaluation in other solid tumors, indicating a broader application of these therapies in both early and advanced stages of cancer.
The Current Landscape of Immune Checkpoint Inhibition for Solid Malignancies.Keung, EZ., Wargo, JA.[2020]
In a study of 155 patients with advanced solid tumors, those with a better performance status (ECOG PS 0-1) had a median overall survival (OS) of 9.1 months, compared to only 2.9 months for those with poorer performance status (ECOG PS 2-4), indicating that performance status significantly impacts treatment outcomes with immune checkpoint inhibitors (ICIs).
Despite having a poor performance status, 27.3% of patients in the study were still alive after one year, and the treatment was generally well-tolerated, with 84.6% of patients experiencing no severe toxicities, suggesting that ICIs can be a safe and effective option for this patient group.
Immune checkpoint inhibitors in patients with solid tumors and poor performance status: A prospective data from the real-world settings.Kapoor, A., Noronha, V., Patil, VM., et al.[2023]
Avelumab, a monoclonal antibody targeting PD-L1, demonstrated an acceptable safety profile in a phase 1a trial with 53 patients, with only one dose-limiting toxicity observed at the highest dose of 20 mg/kg, indicating that the maximum tolerated dose was not reached.
The pharmacokinetic analysis showed a dose-proportional exposure and a half-life of approximately 4 days at higher doses, leading to the selection of 10 mg/kg every 2 weeks for further development, as it achieved over 90% target occupancy.
Avelumab for metastatic or locally advanced previously treated solid tumours (JAVELIN Solid Tumor): a phase 1a, multicohort, dose-escalation trial.Heery, CR., O'Sullivan-Coyne, G., Madan, RA., et al.[2022]

Citations

NCT03448042 | A Study of Runimotamab in Participants ...This study will evaluate the safety, tolerability, and pharmacokinetics of Runimotamab administered intravenously as a single agent and in combination with ...
Runimotamab for Solid Tumors · Info for ParticipantsResearch on immune checkpoint inhibitors, which are similar to Runimotamab, shows they can be effective in treating various solid tumors, even in patients with ...
Runimotamab by Genentech USA for Solid TumorAccording to GlobalData, Phase I drugs for Solid Tumor have a 69% phase transition success rate (PTSR) indication benchmark for progressing into ...
Runimotamab Plus Trastuzumab Shows Encouraging ...Runimotamab plus trastuzumab resulted in positive clinical activity and tolerability over runimotamab alone in patients with HER2-positive breast cancer.
Current landscape of T-cell engagers in early-phase ...This review examines the current landscape of TCEs in early clinical development for the treatment of solid tumors, describing their mechanism, ...
runimotamab (RG6194) / RocheA novel HER2 x CD3 T cell engager with selective activity for HER2-overexpressing tumors and reduced activity on cells with normal HER2 expression levels.
Phase 1a/b study of runimotamab, a HER2 x CD3 T cell ...Runimotamab + trastuzumab demonstrated a manageable safety profile and encouraging clinical activity in heavily pretreated HER2-positive BC ...
Stepping forward: T-cell redirecting bispecific antibodies in ...A subset of solid tumor antigens is expressed in tissues of healthy organs, resulting in varying degrees of off-tumor toxicity. ② Cytokine release syndrome (CRS) ...
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