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

NCT03448042 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: GO40311
• Study Type: interventional
• Target: 123
• Locations: 14 countries
• Sites: 27

Brief 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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with Adverse Events

  From baseline through end of study (approximately 78 months)

Secondary Outcomes (9)

• Serum Concentration of Runimotamab

  At predefined intervals from Cycle 1, Day 1 (approximately 1 year)

• Area Under the Serum Concentration vs. Time Curve (AUC) of Runimotamab

  At predefined intervals from Cycle 1, Day 1 (approximately 1 year)

• Maximum Observed Serum Concentration (Cmax) of Runimotamab

  At predefined intervals from Cycle 1, Day 1 (approximately 1 year)

• Minimum Observed Serum Concentration (Cmin) of Runimotamab

  At predefined intervals from Cycle 1, Day 1 (approximately 1 year)

• Clearance (CL) of Runimotamab

  At predefined intervals from Cycle 1, Day 1 (approximately 1 year)

Study Arms (2)

Dose Escalation

EXPERIMENTAL

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

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.

Drug: Runimotamab; Drug: Trastuzumab; Drug: Tocilizumab

Interventions

Runimotamab DRUG

Runimotamab will be administered via IV infusion until disease progression, intolerable toxicity, or any other discontinuation criteria are met.

Also known as: BTRC4017A, RO7227780

Dose Escalation; Dose Expansion

Trastuzumab DRUG

Trastuzumab will be administered via IV infusion

Dose Escalation; Dose Expansion

Tocilizumab DRUG

Participants will receive IV tocilizumab if needed

Dose Escalation; Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%
• 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
• 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (27)

Yale University

New Haven, Connecticut, 06511, United States

Location

Washington University

Saint Louis, Michigan, 63130, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10017, United States

Location

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Grand Hopital de Charleroi asbl

Charleroi, 6000, Belgium

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Rigshospitalet-Blegdamsvej 9

Copenhagen, 2100, Denmark

Location

EDOG - Institut Bergonie - PPDS

Bordeaux, Gironde, 33000, France

Location

Centre Léon Bérard

Lyon, Rhône, 69008, France

Location

Gustave Roussy

Villejuif, Val-de-Marne, 94805, France

Location

Institut Claudius Regaud

Toulouse, 31059, France

Location

ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda

Milan, Lombardy, 20162, Italy

Location

National Cancer Center East

Chiba, 277-8577, Japan

Location

Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

Amsterdam, 1066 CX, Netherlands

Location

National Cancer Centre

Singapore, 168583, Singapore

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

START MADRID_Hospital Universiario Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

START MADRID_Hospital Universitario HM Sanchinarro - CIOCC - EDOS

Madrid, 28050, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Taiwan University Hospital

Taipei, 10048, Taiwan

Location

Churchill Hospital

Oxford, Oxfordshire, OX3 7LJ, United Kingdom

Location

MeSH Terms

Interventions

Trastuzumab; tocilizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: February 27, 2018
• Study Start: June 6, 2018
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4); CA (1); US (5); AU (1); DK (1); GB (1); KR (2); ES (5); BE (1); NL (1); SG (1); TW (2); JP (1); IT (1)