What side effects are associated with this type of intervention?

Common treatments for HER2-expressing solid tumors, such as trastuzumab and lapatinib, often have side effects including diarrhea, rash, and hepatic adverse events. Trastuzumab is generally well tolerated but can cause chills, fever, nausea, vomiting, weakness, headache, and more seriously, cardiac dysfunction. Lapatinib, when combined with trastuzumab, can lead to similar adverse events, with diarrhea and rash being particularly common. These side effects are generally manageable but require monitoring and supportive care.

What prior FDA approvals exist?

The FDA has approved several treatments for solid tumors that target HER2 or related pathways. Trastuzumab, a monoclonal antibody targeting HER2, is widely used for HER2-positive breast cancer and gastric cancer. Pertuzumab, another HER2-targeted therapy, is often used in combination with Trastuzumab for enhanced efficacy. Additionally, Ado-trastuzumab emtansine (T-DM1) combines Trastuzumab with a cytotoxic agent to deliver targeted chemotherapy. These treatments have significantly improved outcomes for patients with HER2-expressing cancers.

What other types of research exist?

Promising alternatives to Runimotamab for solid tumor patients in 2024 include Trastuzumab Deruxtecan (an antibody-drug conjugate targeting HER2), Tucatinib (a HER2-targeted tyrosine kinase inhibitor), and Margetuximab (a HER2-targeted monoclonal antibody). Additionally, novel immunotherapies and combination therapies involving checkpoint inhibitors and targeted agents are also being explored.

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Monoclonal Antibodies

Runimotamab for Solid Tumors

Phase 1

Waitlist Available

Research Sponsored by Genentech, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

HER2-Expressing Breast Cancer-Specific Inclusion Criteria: Locally tested, Human Epidermal Growth Factor Receptor 2 (HER2)-expressing BC; Locally advanced or metastatic BC that has relapsed or is refractory to established therapies

HER2-Expressing Gastric/Gastroesophageal (GEJ) Cancer-Specific Inclusion Criteria: Adenocarcinoma of the stomach or GEJ with inoperable locally advanced or recurrent and/or metastatic disease, not amenable to curative therapy; HER2-expressing tumor (primary tumor or metastasis) as assessed by local lab testing; HER2-positive gastric/GEJ cancer must have received prior trastuzumab, cisplatin (or carboplatin or oxaliplatin or investigational platinum agent) and 5-fluorouracil (5-FU)/capecitabine

Must not have

Acute or chronic Hepatitis C virus (HCV) infection

Current treatment with medications that are well known to prolong the Q-wave/T-wave (QT) interval

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment, Runimotamab, given alone or with another drug, in patients with advanced cancers that have a lot of a specific protein. The drugs work by attaching to this protein on cancer cells to stop their growth. Hersintuzumab is a new treatment that targets a different part of the protein.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions related to infusion such as fever or chills, organ inflammation due to immune response from the treatment, fatigue from drug action on cancer cells and normal tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is HER2 positive and has either returned or didn't respond to treatment.

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My stomach cancer is advanced, cannot be surgically removed, and has been treated with specific drugs including trastuzumab.

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I am fully active or restricted in physically strenuous activity but can do light work.

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Any major side effects from my previous treatments have mostly gone away.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have Hepatitis C.

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I am not on medications that affect heart rhythm.

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I have had a previous transplant of stem cells or an organ.

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My spinal cord compression hasn't been fully treated.

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My cancer has spread to the lining of my brain and spinal cord.

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I am HIV positive.

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I have a history of irregular heartbeats or risk factors for it.

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I have serious heart or lung problems.

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I do not have an active brain tumor or untreated brain metastases.

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I have a known liver condition.

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My Type 2 diabetes is not well-managed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose ExpansionExperimental Treatment3 Interventions

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

Group II: Dose EscalationExperimental Treatment3 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tocilizumab

2012

Completed Phase 4

~1840

Trastuzumab

2014

Completed Phase 4

~5190

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for solid tumors, particularly those targeting HER2, include monoclonal antibodies like Trastuzumab and antibody-drug conjugates like T-DM1. Trastuzumab binds to the HER2 receptor, inhibiting its signaling pathways, which are crucial for tumor cell growth and survival. T-DM1 combines Trastuzumab with a cytotoxic agent, delivering targeted chemotherapy directly to HER2-positive cancer cells. These treatments are significant for solid tumor patients because they specifically target cancer cells with minimal impact on normal cells, leading to improved efficacy and reduced side effects compared to traditional chemotherapy.

New and emerging combination therapies for esophageal cancer.Promising novel therapies for the treatment of endometrial cancer.