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The primary purpose of the study is to characterize the safety and tolerability of XB371. The dose-escalation cohorts and Part B of the expansion cohorts are non-randomized. Part A of the expansion cohorts is randomized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose-escalation Cohorts | Experimental | Participants will receive escalating doses of XB371 every 3 weeks of a 21-day cycle (alternate schedules may be evaluated) until meeting the criteria for treatment discontinuation. |
|
| Dose-expansion Cohorts: Part A | Experimental | Participants with Tumor Type 1 (tumor type will be selected based on available data) will be randomized to receive XB371 at one of two recommended dose levels (recommended dose [RD]-1 or RD-2) every 3 weeks of a 21-day cycle (alternate schedules may be evaluated) until meeting the criteria for treatment discontinuation. |
|
| Dose-expansion Cohorts: Part B | Experimental | Participants with Tumor Type 2 (tumor type will be selected based on available data) will receive XB371 at the recommended dose level every 3 weeks of a 21-day cycle (alternate schedules may be evaluated) until meeting the criteria for treatment discontinuation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XB371 | Drug | Intravenous (IV) infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with a Dose-limiting Toxicity (DLT) | Up to the end of the first cycle (Up to Day 21 of a 21-day cycle) | |
| Number of Participants with a Treatment-emergent Adverse Event (TEAE) | Up to approximately 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-time Curve (AUC) of XB371, Total Antibody and Unconjugated Belotecan | Up to approximately 7 months | |
| Maximum Observed Plasma Concentration (Cmax) of XB371, Total Antibody and Unconjugated Belotecan | Up to approximately 7 months |
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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 | 1-650-837-7400 |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Exelixis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Exelixis Clinical Site #5 | Recruiting | Rogers | Arkansas | 72758 | United States | |
| Exelixis Clinical Site #9 |
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| Time to Maximum Observed Plasma Concentration (Tmax) of XB371, Total Antibody and Unconjugated Belotecan | Up to approximately 7 months |
| Trough Observed Plasma Concentration (Ctrough) of XB371, Total Antibody and Unconjugated Belotecan | Up to approximately 7 months |
| Number of Participants with Antidrug Antibodies to XB371 | Up to approximately 7 months |
| Dose-escalation Cohorts Only: Recommended Dose(s) for Expansion | Through completion of dose-escalation (up to approximately 18 months) |
| Dose-expansion Cohorts Only: Objective Response Rate as Assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Up to approximately 18 months |
| Dose-expansion Cohorts Only: Duration of Response as Assessed by the Investigator per RECIST v1.1 | Up to approximately 18 months |
| Recruiting |
| Los Angeles |
| California |
| 90033 |
| United States |
| Exelixis Clinical Site #6 | Recruiting | Washington D.C. | District of Columbia | 20057 | United States |
| Exelixis Clinical Site #4 | Recruiting | Orlando | Florida | 32827 | United States |
| Exelixis Clinical Site #3 | Recruiting | Grand Rapids | Michigan | 49546 | United States |
| Exelixis Clinical Site #7 | Recruiting | New Brunswick | New Jersey | 08901 | United States |
| Exelixis Clinical Site #2 | Recruiting | Huntersville | North Carolina | 28078 | United States |
| Exelixis Clinical Site #8 | Recruiting | Houston | Texas | 77030 | United States |
| Exelixis Clinical Site #1 | Recruiting | San Antonio | Texas | 78229 | United States |