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This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design, evaluating MM-151 at varying dose levels and frequencies, and subsequently in combination with irinotecan.
This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design exploring weekly, bi-weekly, and tri-weekly dosing schedules. Successive MM-151 monotherapy cohorts of three or more patients will be treated at escalating doses until a maximum tolerated dose is identified, and subsequently in combination with irinotecan. The study consists of three parts as follows: MM-151 monotherapy dose escalation (Part 1); MM-151 monotherapy expansion cohort in cetuximab-refractory colorectal cancer (Part 2); MM-151 + irinotecan dose escalation (Part 3). It is expected that approximately 4 study sites will participate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MM-151 Dose Escalation | Experimental | MM-151 Dose escalation frequency - once weekly, once every two weeks, once every three weeks |
|
| MM-151 Expansion in KRAS wild type colorectal cancer | Experimental | MM-151 given weekly |
|
| MM-151 + irinotecan | Experimental | MM-151 given weekly, irinotecan 180 mg/m2 given once every two weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MM-151 | Drug | MM-151 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase II dose of MM-151 alone and in combination with irinotecan based either on the maximum tolerated dose (MTD) or maximum dose of 18 mg/kg in patients with advanced solid malignancies. | Two years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of dose limiting toxicities (DLTs) within a cohort | 2 years | |
| Adverse event profile of MM-151 alone and in combination with irinotecan | 2 years | |
| Objective response to MM-151 alone and in combination with irinotecan based on RECIST |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States | ||
| Horizon Oncology Research, Inc. |
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| MM-151 + irinotecan | Drug | MM-151 + irinotecan |
|
|
| 2 years |
| Lafayette |
| Indiana |
| 47905 |
| United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| South Texas Accelerated Research Therapeutics, LLC (START) | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D064726 | Triple Negative Breast Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000607291 | MM-151 |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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