Solid TumorsPhase 1NCT03448042
A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers
A Phase 1 study testing Runimotamab, Trastuzumab and Tocilizumab in people with Solid Tumors, run by Genentech, Inc. at 26 sites in 13 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Runimotamab, Trastuzumab and Tocilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 26 sitesin 13 countries
- Study dates
- 6 Jun 2018to 30 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
26 sites in 13 countries.
26 sites in 13 countries
United States5 sites
MD Anderson Cancer Center
Houston, Texas, 77030
SCRI Oncology Partners
Nashville, Tennessee, 37203
Yale University
New Haven, Connecticut, 06511
Memorial Sloan Kettering Cancer Center
New York, New York, 10017
Washington University
Saint Louis, Michigan, 63130
Spain5 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
START MADRID_Hospital Universiario Fundacion Jimenez Diaz
Madrid, 28040
START MADRID_Hospital Universitario HM Sanchinarro - CIOCC - EDOS
Madrid, 28050
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, 28223
Hospital Clinico Universitario de Valencia
Valencia, 46010
France4 sites
EDOG - Institut Bergonie - PPDS
Bordeaux, Gironde, 33000
Centre Léon Bérard
Lyon, Rhône, 69008
Institut Claudius Regaud
Toulouse, 31059
Gustave Roussy
Villejuif, Val-de-Marne, 94805
South Korea2 sites
Asan Medical Center
Seoul, 05505
Seoul National University Hospital
Seoul, 110-744
Taiwan2 sites
China Medical University Hospital
Taichung, 40447
National Taiwan University Hospital
Taipei, 10048
Italy1 site
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
Milan, Lombardy, 20162
Netherlands1 site
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, 1066 CX
About this study
Official title: 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.
- Conditions
- Solid Tumors
- Being tested
- Runimotamab, Trastuzumab, Tocilizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RunimotamabDrug
Also called BTRC4017A, RO7227780
Runimotamab will be administered via IV infusion until disease progression, intolerable toxicity, or any other discontinuation criteria are met.
TrastuzumabDrug
Trastuzumab will be administered via IV infusion
TocilizumabDrug
Participants will receive IV tocilizumab if needed
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Participants will be assigned sequentially to escalating doses of runimotamab up to the maximum tolerated dose (MTD). Receives: Drug: Runimotamab; Drug: Trastuzumab; Drug: Tocilizumab |
| Dose Expansion | Experimental | Participants will receive runimotamab based on the MTD or maximum allowed dose (MAD) identified during dose escalation. Receives: Drug: Runimotamab; Drug: Trastuzumab; Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Adverse Events
Measured: From baseline through end of study (approximately 78 months)
Secondary outcomes (9)
Serum Concentration of Runimotamab
Measured: At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
Area Under the Serum Concentration vs. Time Curve (AUC) of Runimotamab
Measured: At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
Maximum Observed Serum Concentration (Cmax) of Runimotamab
Measured: At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
Minimum Observed Serum Concentration (Cmin) of Runimotamab
Measured: At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
Clearance (CL) of Runimotamab
Measured: At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
Volume of Distribution at Steady State (Vss) of Runimotamab
Measured: 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)
Measured: Baseline through the end of study (approximately 78 months)
Duration of Response (DOR)
Measured: 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
Measured: At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start6 Jun 2018
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448042
- Sponsor's protocol ID
- GO40311
- Status last verified
- Aug 2026
- First submitted
- 20 Feb 2018
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03448042
- Acronym / sponsor ID
- GO40311
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 27 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: Runimotamab, Drug: Trastuzumab, Drug: TocilizumabParticipants will be assigned sequentially to escalating doses of runimotamab up to the maximum tolerated dose (MTD). |
| Dose Expansion | Experimental | Drug: Runimotamab, Drug: Trastuzumab, Drug: TocilizumabParticipants will receive runimotamab based on the MTD or maximum allowed dose (MAD) identified during dose escalation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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%
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RunimotamabAlso: BTRC4017A, RO7227780Runimotamab will be administered via IV infusion until disease progression, intolerable toxicity, or any other discontinuation criteria are met. | Drug | Dose Escalation, Dose Expansion |
| TrastuzumabTrastuzumab will be administered via IV infusion | Drug | Dose Escalation, Dose Expansion |
| TocilizumabParticipants will receive IV tocilizumab if needed | Drug | Dose Escalation, Dose Expansion |
Primary outcome
Percentage of Participants with Adverse Events
Time frame: From baseline through end of study (approximately 78 months)
9 secondary outcomes
Serum Concentration of Runimotamab
Time frame: 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)
Maximum Observed Serum Concentration (Cmax) of Runimotamab
Time frame: 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)
Clearance (CL) of Runimotamab
Time frame: 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)
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)
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)
Anti-Drug Antibody (ADA) Levels of Runimotamab
Time frame: At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
26 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Runimotamab, Trastuzumab and Tocilizumab in people with Solid Tumors, run by Genentech, Inc. at 26 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Spain, France, South Korea, Taiwan and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Adverse Events (time frame: From baseline through end of study (approximately 78 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.