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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03448042




Registration number
NCT03448042
Ethics application status
Date submitted
20/02/2018
Date registered
27/02/2018

Titles & IDs
Public title
A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers
Scientific 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
Secondary ID [1] 0 0
GO40311
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Runimotamab
Treatment: Drugs - Trastuzumab
Treatment: Drugs - Tocilizumab

Experimental: Dose Escalation - Participants will be assigned sequentially to escalating doses of runimotamab up to the maximum tolerated dose (MTD).

Experimental: Dose Expansion - Participants will receive runimotamab based on the MTD or maximum allowed dose (MAD) identified during dose escalation.


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

Treatment: Drugs: Trastuzumab
Trastuzumab will be administered via IV infusion

Treatment: Drugs: Tocilizumab
Participants will receive IV tocilizumab if needed
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with Adverse Events
Timepoint [1] 0 0
From baseline through end of study (approximately 78 months)
Secondary outcome [1] 0 0
Serum Concentration of Runimotamab
Timepoint [1] 0 0
At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
Secondary outcome [2] 0 0
Area Under the Serum Concentration vs. Time Curve (AUC) of Runimotamab
Timepoint [2] 0 0
At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
Secondary outcome [3] 0 0
Maximum Observed Serum Concentration (Cmax) of Runimotamab
Timepoint [3] 0 0
At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
Secondary outcome [4] 0 0
Minimum Observed Serum Concentration (Cmin) of Runimotamab
Timepoint [4] 0 0
At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
Secondary outcome [5] 0 0
Clearance (CL) of Runimotamab
Timepoint [5] 0 0
At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
Secondary outcome [6] 0 0
Volume of Distribution at Steady State (Vss) of Runimotamab
Timepoint [6] 0 0
At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
Secondary outcome [7] 0 0
Objective Response (OR) as Determined by the Investigator According to Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1)
Timepoint [7] 0 0
Baseline through the end of study (approximately 78 months)
Secondary outcome [8] 0 0
Duration of Response (DOR)
Timepoint [8] 0 0
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)
Secondary outcome [9] 0 0
Anti-Drug Antibody (ADA) Levels of Runimotamab
Timepoint [9] 0 0
At predefined intervals from Cycle 1, Day 1 (approximately 1 year)

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2025
Actual
Sample size
Target
Accrual to date
Final
123
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre; Medical Oncology - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Missouri
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Belgium
State/province [6] 0 0
Charleroi
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Denmark
State/province [8] 0 0
København Ø
Country [9] 0 0
France
State/province [9] 0 0
Bordeaux
Country [10] 0 0
France
State/province [10] 0 0
Lyon
Country [11] 0 0
France
State/province [11] 0 0
Toulouse
Country [12] 0 0
France
State/province [12] 0 0
Villejuif
Country [13] 0 0
Italy
State/province [13] 0 0
Lombardia
Country [14] 0 0
Japan
State/province [14] 0 0
Chiba
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Seoul
Country [16] 0 0
Netherlands
State/province [16] 0 0
Amsterdam
Country [17] 0 0
Singapore
State/province [17] 0 0
Singapore
Country [18] 0 0
Spain
State/province [18] 0 0
Madrid
Country [19] 0 0
Spain
State/province [19] 0 0
Barcelona
Country [20] 0 0
Spain
State/province [20] 0 0
Valencia
Country [21] 0 0
Taiwan
State/province [21] 0 0
Taichung
Country [22] 0 0
Taiwan
State/province [22] 0 0
Taipei
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Genentech, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03448042