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This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and PK of escalating doses of DLYE5953A administered to patients with incurable, locally advanced, or metastatic solid malignancy that has progressed on standard therapy. The Phase I study consists of two stages: Stage 1 dose-escalation and Stage 2 expansion in selected patients. In Stage 1, a 3 + 3 dose-escalation design will be used to examine the safety, tolerability, and PK of increasing doses of DLYE5953A. In Stage 2, patients will be enrolled to further characterize the safety, tolerability, and PK of the proposed dose and schedule for future studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose-Escalation Phase | Experimental |
| |
| Dose-expansion cohort | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DLYE5953A | Drug | Escalating doses of DLYE5953A |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limiting toxicities | Days 1 to 21 | |
| Incidence of adverse events | Up to 32 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total exposure of the drug, defined as the area under the concentration-time curve (AUC) | Up to 32 months | |
| Incidence of anti-DLYE5953A antibodies | Up to 32 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | United States | ||
| Yale Cancer Center; Medical Oncology |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| DLYE5953A |
| Drug |
Administration of DLYE5953A at the recommended phase II dose (RP2D) |
|
| Objective response according to Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1 |
| Up to 32 months |
| Duration of objective response | Up to 32 months |
| Progression-free survival | Up to 32 months |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| Dana Farber Cancer Inst. | Boston | Massachusetts | 02115 | United States |
| Karmanos Cancer Center | Detroit | Michigan | 48201 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |