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This study consists of a Dose-Escalation stage and a Dose Expansion stage. The primary purpose of the dose escalation stage is to determine the maximum tolerated dose (MTD) and/or recommended dosage(s) for expansion (RDE[s]); and the dose expansion stage is to evaluate the preliminary antitumor activity of XB628 as a single agent and in combination with zanzalintinib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation Phase | Experimental | Participants with recurrent advanced or metastatic solid tumors will receive escalating dose levels doses of XB628 as a single agent and in combination with zanzalintinib. |
|
| Dose Expansion | Experimental | Participants with recurrent advanced or metastatic solid tumors will receive XB628 as a single agent and in combination with zanzalintinib. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XB628 | Biological | Intravenous infusion(s) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation Cohort: Number of Participants with Dose Limiting Toxicities (DLTs) | 21 days | |
| Dose Escalation Cohort: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Up to 27 months | |
| Dose Expansion Cohort: Objective Response Rate (ORR) | Up to 27 months |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve (AUC) of XB628 | 25 months | |
| Maximum Plasma Concentration (Cmax) of XB628 | 25 months | |
| Time to Maximum Concentration (Tmax) of XB628 |
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Key Inclusion Criteria:
Key Exclusion Criteria
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Exelixis Clinical Trials | Contact | 1-888-EXELIXIS (888-393-5494) | druginfo@exelixis.com | |
| Backup or International | Contact | 650-837-7400 |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Exelixis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Exelixis Clinical Site #5 | Recruiting | San Francisco | California | 94158 | United States | |
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| Zanzalintinib |
| Drug |
Oral tablet(s) |
|
|
| 25 months |
| Elimination Half-life (T1/2) of XB628 | 25 months |
| Apparent Clearance (CL/F) of XB628 | 25 months |
| Trough Concentration (Ctrough) of XB628 | 25 months |
| Number of Participants with Antidrug Antibody (ADA) Response to XB628 | 25 months |
| RDE for XB628 | 25 months |
| Dose Expansion Cohort: Duration of Response (DOR) | 27 months |
| Dose Expansion Cohort: Progression-Free Survival (PFS) of XB628 | 27 months |
| Exelixis Clinical Site #4 |
| Recruiting |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| Exelixis Clinical Site #8 | Recruiting | Tampa | Florida | 33612 | United States |
| Exelixis Clinical Site #10 | Recruiting | Boston | Massachusetts | 02114 | United States |
| Exelixis Clinical Site #11 | Recruiting | Boston | Massachusetts | 02114 | United States |
| Exelixis Clinical Site #6 | Recruiting | St Louis | Missouri | 63108 | United States |
| Exelixis Clinical Site #7 | Recruiting | New York | New York | 10029 | United States |
| Exelixis Clinical Site #1 | Recruiting | Hickory | North Carolina | 28602 | United States |
| Exelixis Clinical Site #3 | Recruiting | Nashville | Tennessee | 37203 | United States |
| Exelixis Clinical Site #9 | Recruiting | Houston | Texas | 77030 | United States |
| Exelixis Clinical Site #2 | Recruiting | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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