Her2 Amplified Solid TumorsPhase 1MonotherapyNCT00911898
A Study of MM-111 in Patients With Advanced, Refractory Her2 Amplified, Heregulin Positive Cancers
A Phase 1 study testing MM-111 in people with Her2 Amplified Solid Tumors and Metastatic Breast Cancer, run by Merrimack Pharmaceuticals at 4 sites in United States.
Trial summary
This study is an open-label Phase 1 trial of MM-111. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Her2 Amplified Solid Tumors, Metastatic Breast Cancer
- What is being tested?
- MM-111
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2009to Mar 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 must have histologically or cytologically confirmed advanced cancer that is:
- HER2 amplified (IHC 2+ or greater) based on archived tumor evaluation
- Heregulin positive based on a study required fresh biopsy sample performed at screening and confirmed by central laboratory
- Patients must have blocks of archived formalin-fixed, paraffin-embedded tumor tissue available for sectioning and immunohistochemical staining
- Patient's cancer must have recurred or progressed following standard therapy, have not responded to standard therapy, or for which no standard therapy exists.
- Patients must be >= 18 years of age
Show all 15Show fewer
- Patients or their legal representatives must be able to understand and sign an informed consent
- Patients may have measurable or non-measurable tumor(s)
- Patients should have ECOG Performance Score (PS) 0 or 1
- Patients must have adequate bone marrow reserves as evidenced by:
- Absolute neutrophil count (ANC) >= 1,500/uL and
- Platelet count >= 100,000/uL
- Hemoglobin >= 9 g/dL
- Patients must have tumor tissue amenable to biopsy
- Patients must be willing to undergo biopsy prior to treatment to MM-111
Who cannot join
- Patients for whom potentially curative antineoplastic therapy is available
- Patients who are pregnant or lactating
- Patients with an active infection or with an unexplained fever greater than 38.5 C during screening visits or on the first scheduled day of dosing. (At the discretion of the investigator, patients with tumor fever may be enrolled)
- Patients with untreated and/or symptomatic primary or metastatic CNS malignancies (patients with CNS metastases who have undergone surgery or radiotherapy, whose disease is stable, and who have been on a stable dose of corticosteroids for at least 2 weeks prior to the first scheduled day of dosing will be eligible for the trial
- Patients with known hypersensitivity to any of the components of MM-111 or who have had hypersensitivity reactions to fully human monoclonal antibodies (patients with a history of hypersensitivity to trastuzumab, a humanized antibody, are not excluded)
- Patients with known HIV, hepatitis B or C (if patients have previously been treated for C and have undetectable viral loads, they can be considered eligible for the trial)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Indiana University (IUPUI)
Indianapolis, Indiana, 46268
University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Fox Chase Center
Philadelphia, Pennsylvania, 19111
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
About this study
Official title: A Phase 1 and Pharmacologic Study of MM-111 in Patients With Advanced, Refractory Her2 Amplified, Heregulin Positive Cancers
This study is an open-label Phase 1 trial of MM-111.
Read the detailed description
Phase 1: Patients with any solid tumor type may be enrolled to evaluate the safety and tolerability of MM-111.
- Being tested
- MM-111
- Keywords
- Her2 amplified solid tumors, Breast Cancer, Her3/ErbB3, Bispecific Antibody
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MM-111Drug
For Phase 1: Dose-escalation cohorts, drug is administered weekly via IV
| Study group | Role | What they receive |
|---|---|---|
| MM-111 | Experimental | Not described Receives: Drug: MM-111 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) or Maximum Feasible Dose
The Maximum Tolerated Dose (MTD) was defined as the highest dose level in which a DLT is experienced by fewer than two patients in a cohort of 3 - 6 patients. If a DLT is observed in at least two patients in a cohort of 3 - 6 patients, the MTD will be determined to have been exceeded and an additional three patients (up to a total of six) are to be treated at the next lower dose level.
Measured: 28 days
Secondary outcomes (2)
To Determine the Clinical Activity of MM-111 in Patients Based on Objective Response Rate (ORR), Duration of Response (DoR), Progression Free Survival (PFS), and 16 & 24-week Clinical Benefit Rate (CBR)
Measured: December 2011
To Explore the Role Functional Imagining (FDG-PET CT Scan), as a Predictor of Clinical Activity
Measured: December 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Her2 Amplified Solid TumorsStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merrimack Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Muralidhar Beeram, MD, Principal investigator, The START Center for Cancer Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911898
- Sponsor's protocol ID
- MM-111-01-100
- Acronym
- Monotherapy
- Status last verified
- Dec 2014
- First submitted
- 2 Jun 2009
- Last updated
- 13 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 and Pharmacologic Study of MM-111 in Patients With Advanced, Refractory Her2 Amplified, Heregulin Positive Cancers
- ClinicalTrials.gov ID
- NCT00911898
- Acronym / sponsor ID
- Monotherapy / MM-111-01-100
- Keywords
- Her2 amplified solid tumors, Breast Cancer, Her3/ErbB3, Bispecific Antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Merrimack PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 3 Jun 2009 (estimated)
- Results
- Posted 15 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an open-label Phase 1 trial of MM-111.
Detailed description
Phase 1: Patients with any solid tumor type may be enrolled to evaluate the safety and tolerability of MM-111.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MM-111 | Experimental | Drug: MM-111 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must have histologically or cytologically confirmed advanced cancer that is:
- Patients must have blocks of archived formalin-fixed, paraffin-embedded tumor tissue available for sectioning and immunohistochemical staining
- Patient's cancer must have recurred or progressed following standard therapy, have not responded to standard therapy, or for which no standard therapy exists.
- Patients must be >= 18 years of age
- Patients or their legal representatives must be able to understand and sign an informed consent
Key exclusion criteria (6 listed)
- Patients for whom potentially curative antineoplastic therapy is available
- Patients who are pregnant or lactating
- Patients with an active infection or with an unexplained fever greater than 38.5 C during screening visits or on the first scheduled day of dosing. (At the discretion of the investigator, patients with tumor fever may be enrolled)
- Patients with untreated and/or symptomatic primary or metastatic CNS malignancies (patients with CNS metastases who have undergone surgery or radiotherapy, whose disease is stable, and who have been on a stable dose of corticosteroids for at least 2 weeks prior to the first scheduled day of dosing will be eligible for the trial
- Patients with known hypersensitivity to any of the components of MM-111 or who have had hypersensitivity reactions to fully human monoclonal antibodies (patients with a history of hypersensitivity to trastuzumab, a humanized antibody, are not excluded)
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 |
|---|---|---|
| MM-111For Phase 1: Dose-escalation cohorts, drug is administered weekly via IV | Drug | MM-111 |
Primary outcome
Maximum Tolerated Dose (MTD) or Maximum Feasible Dose
Time frame: 28 days
The Maximum Tolerated Dose (MTD) was defined as the highest dose level in which a DLT is experienced by fewer than two patients in a cohort of 3 - 6 patients. If a DLT is observed in at least two patients in a cohort of 3 - 6 patients, the MTD will be determined to have been exceeded and an additional three patients (up to a total of six) are to be treated at the next lower dose level.
2 secondary outcomes
To Determine the Clinical Activity of MM-111 in Patients Based on Objective Response Rate (ORR), Duration of Response (DoR), Progression Free Survival (PFS), and 16 & 24-week Clinical Benefit Rate (CBR)
Time frame: December 2011
To Explore the Role Functional Imagining (FDG-PET CT Scan), as a Predictor of Clinical Activity
Time frame: December 2011
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Her2 Amplified Solid Tumors
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
RecruitingPhase 1
A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC)
Active, not recruitingPhase 2
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer, Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer
RecruitingPhase 1/2
Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
RecruitingPhase 2
Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations
Solid Tumours
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.
Muralidhar Beeram, MD principal investigator
The START Center for Cancer Care
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MM-111 in people with Her2 Amplified Solid Tumors and Metastatic Breast Cancer, run by Merrimack Pharmaceuticals at 4 sites in United States.
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 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 13 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Yes. Results are posted in the registry (first posted 15 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (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 13 Jan 2015.