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Phase 1 Combination Study of MM-151 With MM-121, MM-141, or Trametinib

Primary Purpose

Colorectal Cancer, Non-small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

MM-151

MM-121

MM-141

trametinib

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Heregulin-positive, EGFR, ErbB3, Phase I, Oncology, Cancer, IGF-1, MEKinhibitor, IGF-1R inhibitor, KRAS, NRAS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

University of Colorado
Northside Hospital
Northwestern
Washington University
Vanderbilt

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

MM-151+MM-121 Dose Escalation

MM-151+ trametinib Dose Escalation

MM-151+MM-141 Dose Escalation

MM-151+trametinib Dose Escalation

Colorectal cancer Expansion

Head and neck Expansion

Arm Description

MM-151 and MM-121 dose escalation in lung, head and neck, and colorectal cancers

MM-151 and trametinib dose escalation in lung, head and neck, and colorectal cancers.

MM-151 and MM-141 dose escalation in lung, head and neck, and colorectal cancers

MM-151 and trametinib dose escalation in lung, head and neck, and colorectal cancers.

Doses established in part 1 of the study

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of dose limiting toxicities (DLTs) within a group

Adverse event profile of MM-151 in combination with MM-121, MM-141, and trametinib

Objective response to MM-151 in combination with MM-121, MM-141, and trametinib based on RECIST

Full Information

NCT ID

NCT02538627

First Posted

August 31, 2015

Last Updated

August 31, 2017

Sponsor

Merrimack Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02538627

Brief Title

Phase 1 Combination Study of MM-151 With MM-121, MM-141, or Trametinib

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Terminated

Why Stopped

Sponsor decision

Study Start Date

August 2015 (undefined)

Primary Completion Date

October 5, 2016 (Actual)

Study Completion Date

October 5, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merrimack Pharmaceuticals

4. Oversight

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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, IGF-1R inhibitor, KRAS, NRAS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MM-151+MM-121 Dose Escalation

Arm Type

Experimental

Arm Description

MM-151 and MM-121 dose escalation in lung, head and neck, and colorectal cancers

Arm Title

MM-151+ trametinib Dose Escalation

Arm Type

Experimental

Arm Description

MM-151 and trametinib dose escalation in lung, head and neck, and colorectal cancers.

Arm Title

MM-151+MM-141 Dose Escalation

Arm Type

Experimental

Arm Description

MM-151 and MM-141 dose escalation in lung, head and neck, and colorectal cancers

Arm Title

MM-151+trametinib Dose Escalation

Arm Type

Experimental

Arm Description

MM-151 and trametinib dose escalation in lung, head and neck, and colorectal cancers.

Arm Title

Colorectal cancer Expansion

Arm Type

Experimental

Arm Description

Doses established in part 1 of the study

Arm Title

Head and neck Expansion

Arm Type

Experimental

Arm Description

Doses established in part 1 of the study

Intervention Type

Drug

Intervention Name(s)

MM-151

Intervention Description

MM-151

Intervention Type

Drug

Intervention Name(s)

MM-121

Intervention Description

MM-121

Intervention Type

Drug

Intervention Name(s)

MM-141

Intervention Description

MM-141

Intervention Type

Drug

Intervention Name(s)

trametinib

Other Intervention Name(s)

MEKINIST

Intervention Description

trametininb

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Number of dose limiting toxicities (DLTs) within a group

Time Frame

1.5 years

Title

Adverse event profile of MM-151 in combination with MM-121, MM-141, and trametinib

Time Frame

1.5 years

Title

Objective response to MM-151 in combination with MM-121, MM-141, and trametinib based on RECIST

Time Frame

1.5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Facility Information:

Facility Name

University of Colorado

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Northside Hospital

City

Sandy Springs

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Northwestern

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Washington University

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Vanderbilt

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37235

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Phase 1 Combination Study of MM-151 With MM-121, MM-141, or Trametinib

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