Colorectal CancerPhase 1NCT02538627
Phase 1 Combination Study of MM-151 With MM-121, MM-141, or Trametinib
A Phase 1 study testing MM-151, MM-121 and MM-141 in people with Colorectal Cancer and Non-small Cell Lung Cancer, run by Merrimack Pharmaceuticals at 5 sites in United States.
Trial summary
This is a Phase 1 open-label, dose-escalation trial using "3+3" design, evaluating MM-151 co-administration with MM-121, MM-141, and trametinib at varying dose levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Non-small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- MM-151, MM-121 and MM-141
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2015to 5 Oct 2016
- 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 must be >18 years of age
- Patients must be able to provide informed consent
- Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of any study therapy). This applies to women of childbearing potential as well as fertile men and their partners
- Patients must be recovered from the effects of any prior surgery, radiotherapy or other antineoplastic therapy, up to CTCAE grade 1
- Patients must have either heregulin-positive cancer, cancer with RAS mutation, IGF-1 positive cancer, or RAS wild type cancer.
Who cannot join
- Patients who are pregnant or lactating
- Patients who have an active infection or with an unexplained fever > 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 (primary) or symptomatic CNS (primary or metastatic) malignancies; patients with CNS metastases who have undergone surgery or radiotherapy or who have been on a stable dose of corticosteroids for at least 2 weeks and whose disease is stable prior to the first scheduled day of dosing will be eligible for the trial.
- Patients who have received other recent antitumor therapy including any standard chemotherapy or radiation within 14 days (and having passed the time of any actual or anticipated toxicities) prior to the first scheduled dose of the study treatment.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Colorado
Aurora, Colorado, 80045
Northwestern
Chicago, Illinois, 60611
Vanderbilt
Nashville, Tennessee, 37235
Northside Hospital
Sandy Springs, Georgia, 30342
Washington University
St Louis, Missouri, 63110
About this study
Official title: A Phase 1 Multi Arm Study Evaluating the Safety, Pharmacology and Preliminary Activity of the Co-Administration of MM-151 With Seribantumab (MM-121), Istiratumab (MM-141), or Trametinib in Biomarker-selected Cancer Patients
This is a Phase 1 open-label, dose-escalation trial using "3+3" design, evaluating MM-151 co-administration with MM-121, MM-141, and trametinib at varying dose levels.
Read the detailed description
This is a two-part Phase 1, non-randomized, open-label study of MM-151 plus MM-121, MM-141, or trametinib in patients with advanced, heregulin-positive lung, head and neck, and colorectal cancers. In part 1 of the study, cohorts of 3 or more patients will be treated at escalating doses of MM-151 in combination with MM-121, MM-141, and trametinib until a maximum tolerated combination dose for each combination is identified. In part 2 of the study, patients will be treated with the combination dose identified in part 1 of the study.
- Conditions
- Colorectal Cancer, Non-small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck
- Being tested
- MM-151, MM-121, MM-141, trametinib
- Keywords
- Heregulin-positive, EGFR, ErbB3, Phase I, Oncology, Cancer, IGF-1, MEKinhibitor, IGF-1R inhibitor, KRAS, NRAS
- Medical subject headings
- Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MM-151Drug
MM-151
MM-121Drug
MM-121
MM-141Drug
MM-141
trametinibDrug
Also called MEKINIST
trametininb
| Study group | Role | What they receive |
|---|---|---|
| MM-151+MM-121 Dose Escalation | Experimental | MM-151 and MM-121 dose escalation in lung, head and neck, and colorectal cancers Receives: Drug: MM-151; Drug: MM-121 |
| MM-151+ trametinib Dose Escalation | Experimental | MM-151 and trametinib dose escalation in lung, head and neck, and colorectal cancers. Receives: Drug: MM-151; Drug: trametinib |
| MM-151+MM-141 Dose Escalation | Experimental | MM-151 and MM-141 dose escalation in lung, head and neck, and colorectal cancers Receives: Drug: MM-151; Drug: MM-141 |
| MM-151+trametinib Dose Escalation | Experimental | MM-151 and trametinib dose escalation in lung, head and neck, and colorectal cancers. Receives: Drug: MM-151; Drug: trametinib |
| Colorectal cancer Expansion | Experimental | Doses established in part 1 of the study Receives: Drug: MM-151; Drug: MM-121; Drug: MM-141; Drug: trametinib |
| Head and neck Expansion | Experimental | Doses established in part 1 of the study Receives: Drug: MM-151; Drug: MM-121; Drug: MM-141; Drug: trametinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To find a phase II dose of MM-151 in combination with MM-121, MM-141, and trametinib based on maximum tolerated dose (MTD) in patients with lung, head and neck, and colorectal cancers
Measured: 1.5 years
Secondary outcomes (3)
Number of dose limiting toxicities (DLTs) within a group
Measured: 1.5 years
Adverse event profile of MM-151 in combination with MM-121, MM-141, and trametinib
Measured: 1.5 years
Objective response to MM-151 in combination with MM-121, MM-141, and trametinib based on RECIST
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startAug 2015
- Primary completion5 Oct 2016
- Study completion5 Oct 2016
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merrimack Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538627
- Sponsor's protocol ID
- MM-151-01-01-02
- Status last verified
- Aug 2017
- First submitted
- 31 Aug 2015
- Last updated
- 5 Sep 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Multi Arm Study Evaluating the Safety, Pharmacology and Preliminary Activity of the Co-Administration of MM-151 With Seribantumab (MM-121), Istiratumab (MM-141), or Trametinib in Biomarker-selected Cancer Patients
- ClinicalTrials.gov ID
- NCT02538627
- Acronym / sponsor ID
- MM-151-01-01-02
- Conditions
- Colorectal Cancer, Non-small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck
- Keywords
- Heregulin-positive, EGFR, ErbB3, Phase I, Oncology, Cancer, IGF-1, MEKinhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Merrimack PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- 5 Oct 2016 (actual)
- Study completion
- 5 Oct 2016 (actual)
- First posted
- 2 Sep 2015 (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 a Phase 1 open-label, dose-escalation trial using "3+3" design, evaluating MM-151 co-administration with MM-121, MM-141, and trametinib at varying dose levels.
Detailed description
This is a two-part Phase 1, non-randomized, open-label study of MM-151 plus MM-121, MM-141, or trametinib in patients with advanced, heregulin-positive lung, head and neck, and colorectal cancers. In part 1 of the study, cohorts of 3 or more patients will be treated at escalating doses of MM-151 in combination with MM-121, MM-141, and trametinib until a maximum tolerated combination dose for each combination is identified. In part 2 of the study, patients will be treated with the combination dose identified in part 1 of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| MM-151+MM-121 Dose Escalation | Experimental | Drug: MM-151, Drug: MM-121MM-151 and MM-121 dose escalation in lung, head and neck, and colorectal cancers |
| MM-151+ trametinib Dose Escalation | Experimental | Drug: MM-151, Drug: trametinibMM-151 and trametinib dose escalation in lung, head and neck, and colorectal cancers. |
| MM-151+MM-141 Dose Escalation | Experimental | Drug: MM-151, Drug: MM-141MM-151 and MM-141 dose escalation in lung, head and neck, and colorectal cancers |
| MM-151+trametinib Dose Escalation | Experimental | Drug: MM-151, Drug: trametinibMM-151 and trametinib dose escalation in lung, head and neck, and colorectal cancers. |
| Colorectal cancer Expansion | Experimental | Drug: MM-151, Drug: MM-121, Drug: MM-141, Drug: trametinibDoses established in part 1 of the study |
| Head and neck Expansion | Experimental | Drug: MM-151, Drug: MM-121, Drug: MM-141, Drug: trametinibDoses established in part 1 of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must be >18 years of age
- Patients must be able to provide informed consent
- Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of any study therapy). This applies to women of childbearing potential as well as fertile men and their partners
- Patients must be recovered from the effects of any prior surgery, radiotherapy or other antineoplastic therapy, up to CTCAE grade 1
- Patients must have either heregulin-positive cancer, cancer with RAS mutation, IGF-1 positive cancer, or RAS wild type cancer.
Key exclusion criteria (4 listed)
- Patients who are pregnant or lactating
- Patients who have an active infection or with an unexplained fever > 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 (primary) or symptomatic CNS (primary or metastatic) malignancies; patients with CNS metastases who have undergone surgery or radiotherapy or who have been on a stable dose of corticosteroids for at least 2 weeks and whose disease is stable prior to the first scheduled day of dosing will be eligible for the trial.
- Patients who have received other recent antitumor therapy including any standard chemotherapy or radiation within 14 days (and having passed the time of any actual or anticipated toxicities) prior to the first scheduled dose of the study treatment.
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-151MM-151 | Drug | Colorectal cancer Expansion, Head and neck Expansion, MM-151+ trametinib Dose Escalation, MM-151+MM-121 Dose Escalation, MM-151+MM-141 Dose Escalation, MM-151+trametinib Dose Escalation |
| MM-121MM-121 | Drug | Colorectal cancer Expansion, Head and neck Expansion, MM-151+MM-121 Dose Escalation |
| MM-141MM-141 | Drug | Colorectal cancer Expansion, Head and neck Expansion, MM-151+MM-141 Dose Escalation |
| trametinibAlso: MEKINISTtrametininb | Drug | Colorectal cancer Expansion, Head and neck Expansion, MM-151+ trametinib Dose Escalation, MM-151+trametinib Dose Escalation |
Primary outcome
To find a phase II dose of MM-151 in combination with MM-121, MM-141, and trametinib based on maximum tolerated dose (MTD) in patients with lung, head and neck, and colorectal cancers
Time frame: 1.5 years
3 secondary outcomes
Number of dose limiting toxicities (DLTs) within a group
Time frame: 1.5 years
Adverse event profile of MM-151 in combination with MM-121, MM-141, and trametinib
Time frame: 1.5 years
Objective response to MM-151 in combination with MM-121, MM-141, and trametinib based on RECIST
Time frame: 1.5 years
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 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-151, MM-121 and MM-141 in people with Colorectal Cancer and Non-small Cell Lung Cancer, run by Merrimack Pharmaceuticals at 5 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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
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?
To find a phase II dose of MM-151 in combination with MM-121, MM-141, and trametinib based on maximum tolerated dose (MTD) in patients with lung, head and neck, and colorectal cancers (time frame: 1.5 years). 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 5 Sep 2017.