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| ID | Type | Description | Link |
|---|---|---|---|
| MK-6482-030 | Other Identifier | Merck Sharp & Dohme LLC |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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This is a Phase 1b, open-label, multicenter, safety, tolerability and efficacy study of HC-7366 in combination with belzutifan (WELIREGâ„¢). This is a multipart study that consists of a HC-7366 monotherapy cohort, a combination dose escalation, and a combination dose expansion. Approximately 80 patients will be enrolled in this study (up to 20 patients will be enrolled into the HC-7366 monotherapy cohort, up to 30 patients into the combination dose escalation, and up to 30 patients into the combination dose expansion). The primary purpose of this study is to determine the maximum tolerated dose of HC-7366 in combination with belzutifan in patients with locally advanced (inoperable) or metastatic RCC with predominantly clear cell histology, irrespective of VHL gene mutation status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy | Experimental | Participants will receive HC-7366 monotherapy [dose to be determined] daily |
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| Combination | Experimental | Participants will receive HC-7366 monotherapy [dose to be determined] in combination with belzutifan [120 mg] daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HC-7366 | Drug | HC-7366 is a novel, orally administered, highly selective and potent general control nonderepressible 2 (GCN2) kinase activator. |
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| Measure | Description | Time Frame |
|---|---|---|
| Determination of MTD and RP2D (combination cohorts only) | To identify the maximum tolerated dose (MTD) and/ or recommended Phase 2 dose (RP2D), and evaluate the safety, tolerability and dose-limiting toxicities (DLTs) of HC-7366 in combination with belzutifan in patients with locally advanced (inoperable) or metastatic RCC with predominantly clear cell histology irrespective of VHL gene mutation status | 30 months |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michele Gargano | Contact | 651-675-0300 | mgargano@hibercell.com | |
| Paulette Mattson | Contact | 651-675-0300 | pmattson@hibercell.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Cancer Center | Recruiting | Tucson | Arizona | 85719 | United States |
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| Belzutifan | Drug | Belzutifan is a potent and selective HIF-2α inhibitor |
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| University of California San Diego Moores Cancer Center | Recruiting | La Jolla | California | 92093 | United States |
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| Cedars-Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
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| University of Colorado Anschutz Medical Campus | Recruiting | Aurora | Colorado | 80045 | United States |
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| Rocky Mountain Cancer Centers, LLP | Recruiting | Lone Tree | Colorado | 80124 | United States |
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| Yale - New Haven Hospital | Recruiting | New Haven | Connecticut | 06520 | United States |
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| HealthPartners Cancer Research Center | Recruiting | Saint Paul | Minnesota | 55101 | United States |
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| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
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| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
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| University Hospitals Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
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| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
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| Providence Cancer Institute | Recruiting | Portland | Oregon | 97213 | United States |
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| SCRI Oncology Partners | Recruiting | Nashville | Tennessee | 37203 | United States |
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| Texas Oncology | Recruiting | Dallas | Texas | 75246 | United States |
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| University of Texas Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
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| University Medical Center & Texas Tech Health Science Center | Recruiting | Lubbock | Texas | 79430 | United States |
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| Virginia Cancer Specialists | Recruiting | Fairfax | Virginia | 22031 | United States |
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| Swedish Medical Center | Recruiting | Seattle | Washington | 98104 | United States |
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| Fred Hutchinson Cancer Center | Recruiting | Seattle | Washington | 98109 | United States |
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| University of Wisconsin - Carbone Cancer Center | Recruiting | Madison | Wisconsin | 53705 | United States |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D007680 | Kidney Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000720612 | belzutifan |
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