A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

May 27, 2026 updated by: Genentech, Inc.

A Phase Ia/Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Runimotamab Administered Intravenously as a Single Agent and in Combination With Trastuzumab in Patients With Locally Advanced or Metastatic HER2-Expressing Cancers

This study will evaluate the safety, tolerability, and pharmacokinetics of Runimotamab administered intravenously as a single agent and in combination with Trastuzumab in participants with locally advanced or metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-expressing cancers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
123

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Peter MacCallum Cancer Centre
  • Belgium
      • Charleroi, Belgium, 6000
        • Grand Hopital de Charleroi asbl
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet-Blegdamsvej 9
  • France
      • Toulouse, France, 31059
        • Institut Claudius Regaud
    • Gironde
      • Bordeaux, Gironde, France, 33000
        • EDOG - Institut Bergonie - PPDS
    • Rhône
      • Lyon, Rhône, France, 69008
        • Centre Leon Berard
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94805
        • Gustave Roussy
  • Italy
    • Lombardy
      • Milan, Lombardy, Italy, 20162
        • ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
  • Japan
      • Chiba, Japan, 277-8577
        • National Cancer Center East
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
  • Singapore
      • Singapore, Singapore, 168583
        • National Cancer Centre
  • South Korea
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 110-744
        • Seoul National University Hospital
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28040
        • START MADRID_Hospital Universiario Fundacion Jimenez Diaz
      • Madrid, Spain, 28050
        • START MADRID_Hospital Universitario HM Sanchinarro - CIOCC - EDOS
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Hospital Universitario Quirónsalud Madrid
  • Taiwan
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taipei, Taiwan, 10048
        • National Taiwan University Hospital
  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LJ
        • Churchill Hospital
  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale University
    • Michigan
      • Saint Louis, Michigan, United States, 63130
        • Washington University
    • New York
      • New York, New York, United States, 10017
        • Memorial Sloan Kettering Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • SCRI Oncology Partners
    • Texas
      • Houston, Texas, United States, 77030
        • Md Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Life expectancy of at least 12 weeks
  • Adequate hematologic and end-organ function
  • Acute, clinically significant treatment-related toxicity from prior therapy must have resolved to Grade </=1 prior to study entry
  • Left Ventricular Ejection Fraction (LVEF) >/=50%

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

HER2-Positive Solid Tumor Specific Inclusion Criteria

  • HER2-positive tumor (primary tumor or metastasis) as assessed by local (non-central) laboratory testing
  • Locally advanced, recurrent, or metastatic incurable malignancy that has progressed after at least one available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable, or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized standard of care; or for whom a clinical trial of an investigational agent is considered an acceptable treatment option

Exclusion Criteria

  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 140 days after the last dose of runimotamab
  • Significant cardiopulmonary dysfunction
  • Known clinically significant liver disease
  • Positive for acute or chronic Hepatitis B virus (HBV) infection
  • Acute or chronic Hepatitis C virus (HCV) infection
  • Human Immunodeficiency Virus (HIV) seropositivity
  • Poorly controlled Type 2 diabetes mellitus
  • History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias
  • Current treatment with medications that are well known to prolong the Q-wave/T-wave (QT) interval
  • Known clinically significant liver disease
  • Primary central nervous system (CNS) malignancy, untreated CNS metastases, or active CNS metastases (progressing or requiring corticosteroids for symptomatic control)
  • Leptomeningeal disease
  • Spinal cord compression that has not definitively treated with surgery and/or radiation
  • History of autoimmune disease
  • Prior allogeneic stem cell or solid organ transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dose Escalation
Participants will be assigned sequentially to escalating doses of runimotamab up to the maximum tolerated dose (MTD).
Drug: Runimotamab
Runimotamab will be administered via IV infusion until disease progression, intolerable toxicity, or any other discontinuation criteria are met.
Other Names:
  • BTRC4017A
  • RO7227780
Drug: Trastuzumab
Trastuzumab will be administered via IV infusion
Drug: Tocilizumab
Participants will receive IV tocilizumab if needed
Experimental: Dose Expansion
Participants will receive runimotamab based on the MTD or maximum allowed dose (MAD) identified during dose escalation.
Drug: Runimotamab
Runimotamab will be administered via IV infusion until disease progression, intolerable toxicity, or any other discontinuation criteria are met.
Other Names:
  • BTRC4017A
  • RO7227780
Drug: Trastuzumab
Trastuzumab will be administered via IV infusion
Drug: Tocilizumab
Participants will receive IV tocilizumab if needed

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of Participants with Adverse Events
Time Frame: From baseline through end of study (approximately 78 months)
From baseline through end of study (approximately 78 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Serum Concentration of Runimotamab
Time Frame: At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
Area Under the Serum Concentration vs. Time Curve (AUC) of Runimotamab
Time Frame: At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
Maximum Observed Serum Concentration (Cmax) of Runimotamab
Time Frame: At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
Minimum Observed Serum Concentration (Cmin) of Runimotamab
Time Frame: At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
Clearance (CL) of Runimotamab
Time Frame: At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
Volume of Distribution at Steady State (Vss) of Runimotamab
Time Frame: At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
Objective Response (OR) as Determined by the Investigator According to Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1)
Time Frame: Baseline through the end of study (approximately 78 months)
Baseline through the end of study (approximately 78 months)
Duration of Response (DOR)
Time Frame: From the first occurrence of a documented objective response to first documented disease progression or death from any cause, through the end of the study (approximately 78 months)
From the first occurrence of a documented objective response to first documented disease progression or death from any cause, through the end of the study (approximately 78 months)
Anti-Drug Antibody (ADA) Levels of Runimotamab
Time Frame: At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
At predefined intervals from Cycle 1, Day 1 (approximately 1 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genentech, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 6, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GO40311

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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