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The study was terminated prior to starting the Phase 2 portion due to a business decision.
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| Name | Class |
|---|---|
| Arcus Biosciences, Inc. | INDUSTRY |
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The goal of this clinical trial is to learn about the safety and preliminary antitumor activity of zanzalintinib in combination with AB521 (doublet) and in combination with AB521 plus nivolumab (triplet) in participants with advanced ccRCC or other advanced solid tumors. The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose-finding Cohort A: Zanzalintinib + AB521 | Experimental | Participants with solid tumors will receive zanzalintinib + AB521 |
|
| Dose-finding Cohort B: zanzalintinib + AB521 + nivolumab | Experimental | Participants with ccRCC will receive zanzalintinib + AB521 + nivolumab |
|
| Expansion Cohort 1: Zanzalintinib + AB521 | Experimental | Participants with ccRCC will receive zanzalintinib + AB521 |
|
| Expansion Cohort 2: zanzalintinib + AB521 + nivolumab | Experimental | Participants with ccRCC will receive zanzalintinib + AB521 + nivolumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zanzalintinib | Drug | Specified doses on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-finding Stage: Number of participants with dose-limiting toxicities (DLTs) | Up to 24 months | |
| Expansion Stage: Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the Investigator | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-finding Stage: Number of participants with adverse events (AEs), including serious adverse events (SAEs) and immune-mediated adverse events (imAEs) | Up to 24 months | |
| Dose-finding Stage: Concentration of study treatments (zanzalintinib and AB521) in plasma at specified time points |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Exelixis Site #8 | Los Angeles | California | 90033 | United States | ||
| Exelixis Site #9 |
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|
| AB521 | Drug | Specified doses on specified days |
|
| Nivolumab | Biological | Specified doses on specified days |
|
|
| Up to 24 months |
| Dose-finding Stage: Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the Investigator | Up to 24 months |
| Expansion Stage: Number of participants with adverse events (AEs), including serious adverse events (SAEs), and immune-mediated adverse events (imAEs) | Up to 24 months |
| Expansion Stage: Duration of response (DOR) per RECIST 1.1 as assessed by the Investigator | Up to 24 months |
| Expansion Stage: Progression-free survival (PFS) per RECIST 1.1 as assessed by the Investigator | Up to 24 months |
| Expansion Stage: Overall survival (OS) | Up to 24 months |
| Expansion Stage: Concentration of study treatments (zanzalintinib and AB521) in plasma at specified time points | Up to 24 months |
| Miami |
| Florida |
| 33176 |
| United States |
| Exelixis Clinical Site #1 | Orlando | Florida | 32804 | United States |
| Exelixis Site #11 | Tampa | Florida | 33612 | United States |
| Exelixis Site #6 | Scarborough | Maine | 04074 | United States |
| Exelixis Site #5 | St Louis | Missouri | 63110 | United States |
| Exelixis Clinical Site #3 | New Hyde Park | New York | 11776 | United States |
| Exelixis Site #14 | New York | New York | 10028 | United States |
| Exelixis Site #13 | Shirley | New York | 11987 | United States |
| Exelixis Site #15 | The Bronx | New York | 10469 | United States |
| Exelixis Clinical Site #2 | Nashville | Tennessee | 37203 | United States |
| Exelixis Clinical Site #16 | Salt Lake City | Utah | 84112 | United States |
| Exelixis Site #4 | Spokane | Washington | 99208 | United States |
| Exelixis Site #12 | Madison | Wisconsin | 53792 | United States |
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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