HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell CarcinomaPhase 1NCT01598077
A Phase I Study of LJM716 in Squamous Cell Carcinoma of Head and Neck, or HER2+ Breast Cancer or Gastric Cancer
A Phase 1 study testing LJM716 in people with HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma and HER2 + Breast Cancer, run by Novartis Pharmaceuticals at 8 sites in 5 countries.
Trial summary
This primary purpose of this study is to estimate the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) and preferred dosing schedule of LJM716 given by IV infusion in adult patients with squamous cell carcinoma of head and neck, or esophagus, or HER2 overexpressing metastatic breast cancer or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma, HER2 + Breast Cancer, HER2 + Gastric Cancer
- What is being tested?
- LJM716
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 8 sitesin 5 countries
- Study dates
- Jul 2012to Mar 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Patients with HER2+ breast cancer, or HER2+ gastric cancer, or squamous cell carcinoma of head and neck, or esophageal squamous cell carcinoma
- Site of disease that can be safely biopsied
Who cannot join
- Patients received prior anti-HER3 antibody treatment
- Patients with impaired cardiac function
- Brain metastases that have not been adequately treated
- Malignant disease other than that being treated in this study
- Pregnant or nursing (lactating) women
- Laboratory abnormalities as specified in the protocol Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
United States4 sites
Massachusetts General Hospital SC-5
Boston, Massachusetts, 02114
University of Chicago Medical Center University of Chicago (16)
Chicago, Illinois, 60546
University of Texas/MD Anderson Cancer Center UT MD
Houston, Texas, 77030-4009
University of Utah / Huntsman Cancer Institute Huntsman
Salt Lake City, Utah, 84103
About this study
Official title: A Phase I Study of LJM716 in Patients With Squamous Cell Carcinoma of Head and Neck, or HER2 Overexpressing Metastatic Breast Cancer or Gastric Cancer
This primary purpose of this study is to estimate the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) and preferred dosing schedule of LJM716 given by IV infusion in adult patients with squamous cell carcinoma of head and neck, or esophagus, or HER2 overexpressing metastatic breast cancer or gastric cancer
- Conditions
- HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma, HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma
- Being tested
- LJM716
- Keywords
- Breast cancer, gastric cancer, squamous cell carcinoma of head and neck, esophageal squamous cell carcinoma, Breast cancer, Gastric cancer, Squamous cell carcinoma of head and neck, Esophageal squamous cell carcinoma
- Medical subject headings
- Breast Neoplasms, Stomach Neoplasms, Esophageal Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LJM716Drug
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation and dose expansion | Experimental | Not described Receives: Drug: LJM716 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities (DLTs)
Measured: 4 weeks
Secondary outcomes (8)
Adverse events
Measured: 4 months
Serious adverse events
Measured: 4 months
Pharmacodynamic response to LJM716 in tumor tissue
Measured: 3 months
Frequency of partial responses, complete responses and stable disease according to RECIST
Measured: every 2 months
Serum concentration of antibodies to LJM716
Measured: 18 months
Progression-free survival
Measured: 18 months
Duration of response
Measured: 18 months
Serum concentration of LJM716,
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startJul 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598077
- Sponsor's protocol ID
- CLJM716X2101
- Other IDs
- 2011-004865-33
- Status last verified
- Apr 2014
- First submitted
- 4 May 2012
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Reynolds KL, Bedard PL, Lee SH, Lin CC, Tabernero J, Alsina M, Cohen E, Baselga J, Blumenschein G Jr, Graham DM, Garrido-Laguna I, Juric D, Sharma S, Salgia R, Seroutou A, Tian X, Fernandez R, Morozov A, Sheng Q, Ramkumar T, Zubel A, Bang YJ. A phase I open-label dose-escalation study of the anti-HER3 monoclonal antibody LJM716 in patients with advanced squamous cell carcinoma of the esophagus or head and neck and HER2-overexpressing breast or gastric cancer. BMC Cancer. 2017 Sep 12;17(1):646. doi: 10.1186/s12885-017-3641-6.
PubMed 28899363
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of LJM716 in Patients With Squamous Cell Carcinoma of Head and Neck, or HER2 Overexpressing Metastatic Breast Cancer or Gastric Cancer
- ClinicalTrials.gov ID
- NCT01598077
- Acronym / sponsor ID
- CLJM716X2101
- Conditions
- HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma, HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma
- Keywords
- Breast cancer, gastric cancer, squamous cell carcinoma of head and neck, esophageal squamous cell carcinoma, Breast cancer, Gastric cancer, Squamous cell carcinoma of head and neck, Esophageal squamous cell carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 15 May 2012 (estimated)
- 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 primary purpose of this study is to estimate the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) and preferred dosing schedule of LJM716 given by IV infusion in adult patients with squamous cell carcinoma of head and neck, or esophagus, or HER2 overexpressing metastatic breast cancer or gastric cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose escalation and dose expansion | Experimental | Drug: LJM716 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with HER2+ breast cancer, or HER2+ gastric cancer, or squamous cell carcinoma of head and neck, or esophageal squamous cell carcinoma
- Site of disease that can be safely biopsied
Key exclusion criteria (6 listed)
- Patients received prior anti-HER3 antibody treatment
- Patients with impaired cardiac function
- Brain metastases that have not been adequately treated
- Malignant disease other than that being treated in this study
- Pregnant or nursing (lactating) women
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 |
|---|---|---|
| LJM716 | Drug | Dose escalation and dose expansion |
Primary outcome
Dose-limiting toxicities (DLTs)
Time frame: 4 weeks
8 secondary outcomes
Adverse events
Time frame: 4 months
Serious adverse events
Time frame: 4 months
Pharmacodynamic response to LJM716 in tumor tissue
Time frame: 3 months
Frequency of partial responses, complete responses and stable disease according to RECIST
Time frame: every 2 months
Serum concentration of antibodies to LJM716
Time frame: 18 months
Progression-free survival
Time frame: 18 months
Duration of response
Time frame: 18 months
Serum concentration of LJM716,
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Derived from this study: PubMed 28899363Reynolds KL, Bedard PL, Lee SH, Lin CC, Tabernero J, Alsina M, Cohen E, Baselga J, Blumenschein G Jr, Graham DM, Garrido-Laguna I, Juric D, Sharma S, Salgia R, Seroutou A, Tian X, Fernandez R, Morozov A, Sheng Q, Ramkumar T, Zubel A, Bang YJ. A phase I open-label dose-escalation study of the anti-HER3 monoclonal antibody LJM716 in patients with advanced squamous cell carcinoma of the esophagus or head and neck and HER2-overexpressing breast or gastric cancer. BMC Cancer. 2017 Sep 12;17(1):646. doi: 10.1186/s12885-017-3641-6.
- Results for CLJM716X2101 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LJM716 in people with HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma and HER2 + Breast Cancer, run by Novartis Pharmaceuticals at 8 sites in 5 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada, South Korea, Spain, Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dose-limiting toxicities (DLTs) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01598077, which also lists 1 linked publication.
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 19 Dec 2020.