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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003320-79 | EudraCT Number |
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This is a 2-part study to evaluate the safety and antitumor activity of MSC-1. MSC-1 is a first-in-class, humanized monoclonal antibody (IgG1) which binds to the immunosuppressive human cytokine Leukemia Inhibitory Factor (LIF), and is intended to treat adult patients with Advanced Solid Tumors.
In part 1, multiple dose levels of MSC-1 in patients with advanced solid tumors will be studied to determine the recommended dose for further evaluation of safety and efficacy in Part 2.
MSC-1 is a first-in-class, humanized monoclonal antibody (IgG1) which binds to the immunosuppressive human cytokine Leukemia Inhibitory Factor (LIF), and is intended to treat adult patients with advanced solid tumors. LIF is a pleiotropic cytokine involved in many physiological and pathological processes including the promotion of an immunosuppressive environment. In cancer, it is hypothesized that LIF expressing malignancies co-opt this activity, creating an immunosuppressive tumor microenvironment as well as promoting the activity of cancer-initiating cell(s) (CICs). LIF is highly expressed in a subset of tumors across multiple solid tumor types.
During dose escalation, patients with advanced solid tumors will be treated with MSC-1 with the primary objective of determining the safety and tolerability of MSC-1 and defining an appropriate dose for further evaluation in dose expansion. MSC-1 will be administered intravenously (IV) until disease progression, unmanageable toxicity, withdrawal of consent or study termination.
In dose expansion, up to 4 parallel cohorts of patients with LIF-High tumors (NSCLC, Ovarian Cancer, Pancreatic Cancer), and a cohort of mixed solid tumors (referred to as the "basket cohort"), may be treated at the recommended expansion dose to further characterize the safety, tolerability, PK, PD and anti-tumor activity of MSC-1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | Multiple dose levels of MSC-1 treatment once every 3 weeks |
|
| Dose Expansion | Experimental | MSC-1 treatment at the recommended Phase 2 dose once every 3 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSC-1 | Biological | humanized monoclonal antibody for intravenous administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety and tolerability of MSC-1 and determine the recommended dose for MSC-1 monotherapy for further evaluation in the expansion part of the study | Assessment of frequency & severity of adverse events | Patients will be evaluated for approximately 6 months or until disease progression |
| Assess the preliminary anti-tumor activity of MSC-1 monotherapy | Determine objective response rate (ORR) | Patients will be evaluated for approximately 6 months or until disease progression |
| Measure | Description | Time Frame |
|---|---|---|
| Confirm safest dose of MSC-1 for further study | Assessment of adverse events | Patients will be evaluated for approximately 6 months or until disease progression |
| Characterize the PK of MSC-1 | Serum levels of MSC-1 |
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Inclusion Criteria (All patients):
Inclusion Criteria (Dose Expansion patients only)
Exclusion Criteria (All Patients):
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth | Scottsdale | Arizona | 85258 | United States | ||
| START MidWest |
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| Label | URL |
|---|---|
| Sponsor Website | View source |
| CSR Synopsis | View source |
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Open-Label
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| Patients will be evaluated before and after each dose of MSC-1 for approximately 6 months or until disease progression. PK will be evaluated more frequently for the first 2 cycles of treatment |
| Grand Rapids |
| Michigan |
| 49546 |
| United States |
| Memorial Sloan Kettering Cancer Center- Monmouth | Middletown | New Jersey | 07748 | United States |
| Memorial Sloan Kettering Cancer Center- Westchester | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Princess Margaret Cancer Center | Toronto | Ontario | M5G 1Z5 | Canada |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
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