Solid TumorsPhase 1NCT01271972
Study of Nesvacumab (REGN910/ SAR307746)
A Phase 1 study testing nesvacumab (REGN910/ SAR307746) in people with Solid Tumors, run by Regeneron Pharmaceuticals at 3 sites in 2 countries.
Trial summary
This is an open-label, multicenter, ascending, multiple dose study of nesvacumab (REGN910/ SAR307746) administered IV every 2 weeks. 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?
- nesvacumab (REGN910/ SAR307746)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2011to May 2015
- 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
- Confirmed diagnosis of advanced solid malignancy.
- ECOG performance status 0 - 1
- Adequate hepatic, renal and bone marrow function
- At least 3 weeks since last dose of chemotherapy, hormonal therapy or radiotherapy
- At least 6 weeks since last dose of bevacizumab
- At least 4 weeks since last surgery
- At least 4 weeks since last dose of investigational treatment
Who cannot join
- Patients with brain metastases, spinal cord compression, carcinomatous meningitis, or other evidence of central nervous system involvement
- Patients with serious non healing wound or acute ulcer
- Either systolic blood pressure >150 mm Hg or diastolic blood pressure >95 mm Hg
- Patients with medical history of myocardial infarction, unstable angina pectoris, coronary/ peripheral artery bypass graft, congestive heart failure or ventricular arrhythmia
- Patients with deep vein thrombosis or pulmonary embolism within last 6 months
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Study site
San Antonio, Texas
Study site
San Francisco, California
About this study
Official title: A Phase 1 Study of REGN910 Administered Every 2 Weeks in Patients With Advanced Solid Malignancies
This is an open-label, multicenter, ascending, multiple dose study of nesvacumab (REGN910/ SAR307746) administered IV every 2 weeks.
- Conditions
- Solid Tumors
- Being tested
- nesvacumab (REGN910/ SAR307746)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nesvacumab (REGN910/ SAR307746)Drug
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Dose 1 Receives: Drug: nesvacumab (REGN910/ SAR307746) |
| Cohort 2 | Experimental | Dose 2 Receives: Drug: nesvacumab (REGN910/ SAR307746) |
| Cohort 3 | Experimental | Dose 3 Receives: Drug: nesvacumab (REGN910/ SAR307746) |
| Cohort 4 | Experimental | Dose 4 Receives: Drug: nesvacumab (REGN910/ SAR307746) |
| Cohort 5 | Experimental | Dose 5 Receives: Drug: nesvacumab (REGN910/ SAR307746) |
| Expansion Cohort 1 | Experimental | Dose 4 Receives: Drug: nesvacumab (REGN910/ SAR307746) |
| Expansion Cohort 2 | Experimental | Dose 5 Receives: Drug: nesvacumab (REGN910/ SAR307746) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximum tolerable dose or recommended phase 2 dose of nesvacumab (REGN910/ SAR307746) in patients with advanced solid malignancies
Measured: 28 days
Secondary outcomes (4)
PK/PD profile
Measured: 28 days
Immunogenicity
Measured: 28 days
Anti-tumor activity
Measured: 28 days
Correlative biomarkers
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionSep 2014
- Study completionMay 2015
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 Regeneron 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271972
- Sponsor's protocol ID
- R910-ST-1010
- Status last verified
- Jun 2015
- First submitted
- 5 Jan 2011
- Last updated
- 16 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of REGN910 Administered Every 2 Weeks in Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT01271972
- Acronym / sponsor ID
- R910-ST-1010
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- Jan 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 7 Jan 2011 (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 is an open-label, multicenter, ascending, multiple dose study of nesvacumab (REGN910/ SAR307746) administered IV every 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: nesvacumab (REGN910/ SAR307746)Dose 1 |
| Cohort 2 | Experimental | Drug: nesvacumab (REGN910/ SAR307746)Dose 2 |
| Cohort 3 | Experimental | Drug: nesvacumab (REGN910/ SAR307746)Dose 3 |
| Cohort 4 | Experimental | Drug: nesvacumab (REGN910/ SAR307746)Dose 4 |
| Cohort 5 | Experimental | Drug: nesvacumab (REGN910/ SAR307746)Dose 5 |
| Expansion Cohort 1 | Experimental | Drug: nesvacumab (REGN910/ SAR307746)Dose 4 |
| Expansion Cohort 2 | Experimental | Drug: nesvacumab (REGN910/ SAR307746)Dose 5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed diagnosis of advanced solid malignancy.
- ECOG performance status 0 - 1
- Adequate hepatic, renal and bone marrow function
- At least 3 weeks since last dose of chemotherapy, hormonal therapy or radiotherapy
- At least 6 weeks since last dose of bevacizumab
Key exclusion criteria (5 listed)
- Patients with brain metastases, spinal cord compression, carcinomatous meningitis, or other evidence of central nervous system involvement
- Patients with serious non healing wound or acute ulcer
- Either systolic blood pressure >150 mm Hg or diastolic blood pressure >95 mm Hg
- Patients with medical history of myocardial infarction, unstable angina pectoris, coronary/ peripheral artery bypass graft, congestive heart failure or ventricular arrhythmia
- Patients with deep vein thrombosis or pulmonary embolism within last 6 months
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 |
|---|---|---|
| nesvacumab (REGN910/ SAR307746) | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Expansion Cohort 1, Expansion Cohort 2 |
Primary outcome
Determine the maximum tolerable dose or recommended phase 2 dose of nesvacumab (REGN910/ SAR307746) in patients with advanced solid malignancies
Time frame: 28 days
4 secondary outcomes
PK/PD profile
Time frame: 28 days
Immunogenicity
Time frame: 28 days
Anti-tumor activity
Time frame: 28 days
Correlative biomarkers
Time frame: 28 days
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 16 Jun 2015.
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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 Trial Management study director
Regeneron Pharmaceuticals
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing nesvacumab (REGN910/ SAR307746) in people with Solid Tumors, run by Regeneron Pharmaceuticals at 3 sites in 2 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 7 inclusion and 5 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 16 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. 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?
Determine the maximum tolerable dose or recommended phase 2 dose of nesvacumab (REGN910/ SAR307746) in patients with advanced solid malignancies (time frame: 28 days). 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 16 Jun 2015; AzTrials last refreshed its copy on 1 Nov 2026.