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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 baseline through the end of study (approximately 78 months)
Awards & highlights

Summary

This trial will study the safety and effectiveness of a new drug for HER2-positive cancers. The drug will be given alone and with another cancer drug.

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~baseline through the end of study (approximately 78 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through the end of study (approximately 78 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants with Adverse Events
Secondary outcome measures
Anti-Drug Antibody (ADA) Levels of Runimotamab
Area Under the Serum Concentration vs. Time Curve (AUC) of Runimotamab
Clearance (CL) of Runimotamab
+6 more

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
Trastuzumab
2014
Completed Phase 4
~5190
Tocilizumab
2012
Completed Phase 4
~1840

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.

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor
1,542 Previous Clinical Trials
567,540 Total Patients Enrolled
Clinical TrialsStudy DirectorGenentech, Inc.
2,204 Previous Clinical Trials
889,769 Total Patients Enrolled

Media Library

Runimotamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03448042 — Phase 1
Solid Tumors Research Study Groups: Dose Escalation, Dose Expansion
Solid Tumors Clinical Trial 2023: Runimotamab Highlights & Side Effects. Trial Name: NCT03448042 — Phase 1
Runimotamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03448042 — Phase 1
~65 spots leftby May 2025