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DBC-664-ONC-101 is a first-in-human Phase 1a/1b open-label, multicenter study to evaluate the safety, tolerability, PK, pharmacodynamic, and preliminary anti-tumor activity of DBC-664 in patients with endometrial cancer, ovarian cancer, and other advanced solid tumors . This study is divided into 2 parts: Phase-1a Dose Escalation (Part 1), and Phase-1b Dose Expansion (Part 2). In each part, patients who meet specific eligibility criteria will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 (Dose Escalation) | Experimental | Participants will receive DBC-664 to determine the recommended dose for expansion (RDE) regimen. |
|
| Part 2 (Dose Expansion) | Experimental | Participants will receive DBC-664 at the RDE as determined in Part 1 of the study to confirm the safety and anti-tumor activity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DBC-664 | Biological | DBC-664 will be administered intravenously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | The safety and tolerability of DBC-664 in patients with solid tumor measured by frequency and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs), adverse events of special interest (AESIs), adverse events (AEs) leading to dose interruption and of adverse events (AEs) leading to treatment discontinuation | 2 years |
| Determine Recommended Dose for Expansion | To determine the maximum tolerated dose (MTD) and/or select the recommended dose(s) for expansion (RDE[s]) of DBC-664 | 1 year |
| Characterize Pharmacokinetics | To characterize the pharmacokinetics (PK) of DBC-664 with Cmax following administration | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Knapp | Contact | +1 (650) 442-3367 | lknapp@tcglsoleil.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| START Midwest | Recruiting | Grand Rapids | Michigan | 49546 | United States | |
| START New Jersey |
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| Recruiting |
| East Brunswick |
| New Jersey |
| 08816 |
| United States |
| START New York | Recruiting | Lake Success | New York | 11402 | United States |
| ID | Term |
|---|---|
| D000077192 | Adenocarcinoma of Lung |
| D000230 | Adenocarcinoma |
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
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