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This is an open-label, phase 1 study to determine the maximum tolerated dose (MTD) or appropriate target dose if MTD not reached to identify the recommended phase 2 dose of LOR-253 HCl in patients with advanced or metastatic solid tumours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LOR-253 HCl | Experimental | LOR-253 HCl will be given in ascending doses until the maximum administered dose or appropriate target dose is reached. A biomarker study of up to 10 patients will be conducted upon achieving appropriate dose level. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LOR-253 HCl | Drug | LOR-253 HCl will be given in ascending doses starting from 20 mg/m2 until the maximum administered dose or appropriate target dose is reached. Patient will be treated on LOR-253 HCl for 2 cycles for the evaluation. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the maximum tolerated dose (MTD) or appropriate target dose if MTD not reached to identify the recommended phase 2 dose of LOR-253 HCl in patients with advanced or metastatic solid tumours. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the safety profile of LOR-253 HCl when administered to patients with advanced or metastatic solid tumours. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Cercek, M.D. | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Jennifer Wheler, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States | ||
| MD Anderson Cancer Center |
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|
| Houston |
| Texas |
| 77030 |
| United States |